Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for Outpatient Medical Treatment

Issued pursuant to
Section 5, Clause 20 of the Pharmaceutical Law

I. General Provisions

1. This Regulation prescribes the procedures for the reimbursement of expenditures for the acquisition of medicinal products and medical devices intended for outpatient medical treatment (hereinafter - the procedures for reimbursement).

2. These procedures for reimbursement are a set of measures, that provide an opportunity for a patient to acquire medicinal products and medical devices, the expenditures for the acquisition of which in accordance with this Regulation are completely or partially covered by the funds from the State budget for the current year granted for the reimbursement of expenditures for the acquisition of medicinal products (hereinafter - the funds granted for reimbursement). The purpose of measures included in these procedures for reimbursement is to ensure medicinal products and medical devices for as wide range of patients as possible within the framework of the funds granted for reimbursement, and also to achieve the lowest possible price of reimbursable medicinal products and medical devices, and to direct the resources obtained as a result of saving for the improvement of health of patients and achievement of the medical treatment objectives.

[22 September 2009; 27 December 2011; 21 October 2014; 26 May 2015]

2.¹ Settlement for medicinal products and medical devices, which are distributed in accordance with the procedures for reimbursement, shall be performed in euros.

[25 August 2009; 10 September 2013]

2.² The price of reimbursable medicinal products shall be determined by applying the Cabinet regulations regarding the principles for the determination of the price of medicinal products.

[16 July 2024]

II. Basic Principles of the Procedures for Reimbursement

3. Expenditures for the acquisition of medicinal products included on the list of reimbursable medicinal products (a list that includes medicinal products and medical devices the expenditures for the acquisition of which are covered from the funds granted for reimbursement in conformity with this Regulation) (hereinafter - the reimbursable medicinal products) and of medical devices included therein (hereinafter - the reimbursable medical devices) shall be covered in accordance with this Regulation for patients who have been diagnosed with any of the diseases referred to in Annex 1 to this Regulation or in the case referred to in Paragraph 52.¹ or Sub-paragraph 92.1 of this Regulation, taking into account the nature and level of seriousness of the disease and complying with reimbursement restrictions and prescription conditions.

[21 December 2021]

3.¹ Expenditures for the acquisition of medicinal products and medical devices shall be covered in full amount from the funds granted for reimbursement for a patient who has been recognised as a needy person or an asylum seeker in accordance with the procedures laid down in laws and regulations and who is entitled to receive reimbursement of expenditures for the acquisition of medicinal products or medical devices in accordance with this Regulation, except the following cases:

3.¹ 1. the patient has been prescribed non-reference medicinal products or medical devices included on the List A of reimbursable medicinal products. In such case the patient shall cover the difference between the pharmacy price of non-reference and reference medicinal products or medical devices of the relevant group (with value added tax);

3.¹ 2. the costs of medicinal products or medical devices prescribed exceed the amount laid down in Paragraph 100 of this Regulation.

[26 January 2010; 21 October 2014; 20 September 2016; 16 July 2019]

3.² [27 December 2011 / See Paragraph 2 of Amendments]

3.³ [27 December 2011 / See Paragraph 2 of Amendments]

3.⁴ [27 December 2011 / See Paragraph 2 of Amendments]

3.⁵ The patient referred to in Paragraph 3.1 of this Regulation shall present a statement in a pharmacy on conformity with the status of a needy family (person) issued by the social service office of the local government in accordance with the laws and regulations on recognition of a family or a person living separately as needy or a personal document of an asylum seeker issued by the State Border Guard.

[27 December 2011; 20 September 2016]

3.⁶ The expenditures for the acquisition of medicinal products and medical devices shall be covered in full amount for a patient until reaching 18 years of age who in accordance with this Regulation is due reimbursement of expenditures for the acquisition of medicinal products or medical devices, except the following cases:

3.⁶ 1. the patient has been prescribed non-reference medicinal products or medical devices included on the List A of reimbursable medicinal products. In such case the patient shall cover the difference between the pharmacy price of non-reference and reference medicinal products or medical devices of the relevant group (with value added tax);

3.⁶ 2. the patient has been prescribed medicinal products included on the List M, expenditures for the acquisition of which are covered in accordance with the procedures laid down in Sub-paragraph 9.2 of this Regulation;

3.⁶3. there exist the reimbursement restrictions specified in Sub-paragraphs 6.2.2 and 8.16 of Annex 1 to this Regulation;

3.⁶ 4. the costs of medicinal products or medical devices prescribed exceed the amount laid down in Paragraph 100 of this Regulation.

[17 December 2013; 26 May 2015; 31 October 2023]

4. Expenditures for the acquisition of reimbursable medicinal products shall be covered, applying the following reimbursement categories:

4.1. Category I - reimbursement in the amount of 100 % or in the amount of the reference price of the relevant group (in respect of medicinal products and medical devices included on List A of reimbursable medicinal products), if it has been determined that a patient has a chronic, life-threatening disease or a disease, which causes serious irreversible disability and the medical treatment of which requires the use of the respective medicinal products in order to maintain the patient's vital functions;

4.2. Category II - reimbursement in the amount of 75 % or - in respect of medicinal products and medical devices included on List A of reimbursable medicinal products - in the amount of 75 % of the reference price of the relevant group, if it has been determined that a patient has a chronic disease, in the medical treatment of which the maintenance of the patient's vital functions is made difficult or which causes serious disability without the use of the respective medicinal products;

4.3. Category III - reimbursement in the amount of 50 % or - in respect of medicinal products and medical devices included on List A of reimbursable medicinal products - in the amount of 75 % of the reference price of the relevant group, if it has been determined that a patient has a chronic or acute disease, in the medical treatment of which the use of the respective medicinal products is necessary in order to maintain or improve the patient's state of health or in case where vaccines are paid for from the funds granted for reimbursement.

[27 January 2009; 27 December 2011]

4.¹ [16 July 2024]

4.² [16 July 2024]

5. Groups of reimbursable medical devices and the amount of reimbursement thereof shall be determined in accordance with Annex 2 to this Regulation.

6. The list of reimbursable medicinal products shall consist of four parts, specifically, List A, List B, List C, and List R. The list of reimbursable medicinal products shall be drawn up according to the following basic principles:

6.1. List A shall include medicinal products of equal therapeutic efficacy within the scope of the common medicinal product name, which conforms to the seven-digit code of the medicinal product in the anatomical therapeutic chemical classification (hereinafter - the common medicinal product name), or the pharmaco-therapeutic group of the medicinal products and medical devices of the same type of the use in accordance with the criteria referred to in Paragraph 23 and Chapter IV of this Regulation;

6.2. List B shall include such medicinal products and medical devices, which do not comply with the criteria referred to in Chapter IV, in accordance with the criteria referred to in Paragraph 23 and Chapter V of this Regulation;

6.3. in accordance with the criteria referred to in Chapter VI of this Regulation, List C shall include such medicinal products and medical devices the costs of which for medical treatment of one patient shall be covered by delivery of the specific amount of medicinal products or medical devices to the medical treatment institution free of charge and to which the prescription conditions referred to in Paragraph 55 of this Regulation are not sufficient in order to limit the number of patients according to the funds granted for reimbursement;

6.4. in accordance with the criteria referred to in Chapter VI¹ of this Regulation, List R shall include medicinal products and medical devices which are intended for the treatment of rare diseases. These shall be included on the list of reimbursable medicinal products by the committee established pursuant to Paragraph 52.² of this Regulation in accordance with the budget funds granted for the treatment of rare diseases in the relevant calendar year if the incremental cost-effectiveness ratio per patient for an additional year of life gained, a year of life without disease progression, or a quality year of life does not exceed EUR 300 000, and also taking into account the cost reduction participation model offered by the manufacturer.

[21 December 2021; 26 March 2024]

7. Medicinal products that are applied for inclusion on the list of reimbursable medicinal products shall comply with the following conditions:

7.1. they are included on the list of medicinal products authorised in the Republic of Latvia or authorised with the European Medicines Agency under a centralised authorisation procedure of medicinal products, or are distributed in parallel or parallel imported in accordance with the laws and regulations on the bringing in and distribution of medicinal products, or there is a permit to bring in and distribute the respective medicinal products in the territory of the Republic of Latvia in accordance with Section 10, Clause 7 of the Pharmaceutical Law;

7.2. the medicinal products are classified as prescription medicinal products in accordance with the laws and regulations on the classification of medicinal products;

7.3. the medicinal products are intended for use in case of a disease specified in Annex 1 to this Regulation or the medicinal products are included on List R of reimbursable medicinal products.

[27 January 2009; 25 August 2009; 21 December 2021]

8. Homeopathic medicinal products shall not be included on the list of reimbursable medicinal products.

9. Medical devices that are applied for inclusion on the list of reimbursable medicinal products shall comply with the following conditions:

9.1. EC declaration of conformity has been drawn up for them and they have been labelled with CE conformity marking in accordance with the laws and regulations on the registration, conformity assessment and distribution of medical devices;

9.2. medical devices intended for use in the event of any of the diseases referred to in Annex 1 to this Regulation.

[29 March 2011]

9.¹ Medicinal products reimbursable within the scope of the reimbursement procedures, which are used by pregnant women, women during the period following childbirth up to 70 days and children up to the age of 24 months, but which are not included on the list of reimbursable medicinal products, shall form List M (hereinafter - the List M medicinal products) and they shall conform to the following conditions:

9.¹1. they are included on the list of medicinal products authorised in the Republic of Latvia or authorised with the European Medicines Agency under a centralised authorisation procedure of medicinal products, or are parallel distributed or parallel imported in accordance with the laws and regulations on the bringing in and distribution of medicinal products;

9.¹ 2. they are classified as prescription medicinal products, except:

9.¹2.1. medicinal products which, in accordance with the laws and regulations regarding the procedures for the classification of medicinal products, correspond to the designation Pr. I, Pr. II stac., or Pr. III;

9.¹2.2. medicinal products in prescribing of which, in accordance with the laws and regulations on the prescribing of prescription medicinal products, the programme for avoiding pregnancy developed by the holder (owner) of the marketing authorisation for medicinal products and co-ordinated with the State Agency of Medicines is conformed to;

9.¹2.3. vaccines which, in accordance with the laws and regulations on vaccination, are included in the vaccination calendar and are paid for within its scope;

9.¹3. they have the price declared in the State Agency of Medicines in accordance with the laws and regulations on the principles of creation of prices for medicinal products.

[24 July 2012; 21 October 2014; 7 August 2018]

9.² The expenditures for the acquisition of the List M medicinal products shall be covered, applying the following reimbursement categories:

9.²1. reimbursement in the amount of 50 % for a child up to the age of 24 months, if a diagnosis with another amount of reimbursement has not been determined for him or her;

9.²2. reimbursement in the amount of 25 % for a pregnant woman or a woman during the period following childbirth up to 70 days, if a diagnosis with another amount of reimbursement has not been determined for her.

[24 July 2012; 7 August 2018]

10. Expenditures for the acquisition of medicinal products and medical devices shall be reimbursed in accordance with the list of reimbursable medicinal products and List M which is created and maintained by the National Health Service. The National Health Service shall indicate on the list the common medicinal product name, the medicinal product name, the code of the medicinal product in the anatomical therapeutic chemical classification, the identification number, the owner of the marketing authorisation, the pharmaceutical form, the strength, the size of the packaging, the basic price of reimbursement, the pharmacy price (with value added tax), the amount of reimbursement, the category of the list and the time period of inclusion of a medicinal product, if the medicinal product is included for a certain time period, and also the group, the name, the identification number, the owner of the marketing authorisation, the size of the packaging, the basic price of reimbursement, the pharmacy price (with value added tax), the amount of reimbursement, the category of the list and the time period of inclusion of a medical device, if the medical device is included for a definite time period.

[25 August 2009; 22 September 2009; 19 October 2011; 24 July 2012 / Amendments to the Paragraph shall come into force on 1 September 2012. See Paragraph 3 of Amendments]

10.¹ The National Health Service shall determine the basic reimbursement price and pharmacy price for the List M medicinal products on the basis of the price declared by the manufacturer with the State Agency of Medicines in accordance with the laws and regulations regarding the principles for the creation of prices for medicinal products and applying corresponding mark-ups. The National Health Service shall update the prices using the manufacturer's price declared with the State Agency of Medicines in the calculations.

[27 May 2025]

II.¹ Receiving of an Opinion from the State Agency of Medicines

[16 July 2019]

10.² The State Agency of Medicines shall perform the assessment of therapeutic effectiveness and cost-effectiveness and provide an opinion on medicinal products and medical devices in relation to the following:

10.²1. the therapeutic effectiveness and cost-effectiveness of a new common name of medicinal products or a new combination of the common names of medicinal products, except for the cases referred to in Sub-paragraph 12.1 of this Regulation;

10.²2. the therapeutic effectiveness and cost-effectiveness of the common name of medicinal products for the revision of reimbursement conditions;

10.²3. the cost-effectiveness of medical devices not included in Annex 2 of this Regulation and the revision of their reimbursement conditions.

[16 July 2024]

10.³ In order to receive an opinion, the applicant shall submit an application to the State Agency of Medicines. The application shall indicate:

10.³1. information regarding the applicant (the name, registration number, legal address of the legal person) and the payer (settlement details);

10.³2. information regarding the medicinal product or medical device (the name, the registration number, the registration date, the manufacturer's price and the anticipated basic price of reimbursement, the number of doses in a packaging (hereinafter - the size of the packaging). In one application, the applicant shall indicate the common name of the medicinal products, their combinations, the code of the medicinal products in the Anatomical Therapeutic Chemical classification (hereinafter - the ATC/DDD classification), the form of the medicinal products and the strength of the medicinal products (the amount of active substances in the dose) for the medicinal products to be assessed;

10.³3. the disease, indicating the diagnosis code according to the International Statistical Classification of Diseases and Related Health Problems (10th Revision) (hereinafter - the ICD), and the target group of patients for whose treatment the assessment of therapeutic effectiveness and cost-effectiveness is to be performed.

[21 December 2021; 16 July 2024]

10.⁴ The following documents and information shall be attached to the application referred to in Paragraph 10.³ of this Regulation:

10.⁴1. a summary of clinical studies with an indication of unlimited access to the full texts of the specified studies or the relevant publications and their annexes in a human-readable format which demonstrate the effectiveness and advantages of these medicinal products or medical devices for the relevant diagnosis and patient group specified in the application compared to other alternative therapies available in Latvia;

10.⁴2. pharmacoeconomic calculations in accordance with the guidelines for the economic evaluation of medicinal products specified in Annex 3 to this Regulation;

10.⁴3. at the discretion of the applicant, proposals for financial participation to improve cost-effectiveness indicators compared to the standard therapy available in Latvia.

[16 July 2019; 16 July 2024]

10.⁵ In addition to the documents and information referred to in Paragraphs 10.³ and 10.⁴ of this Regulation, the State Agency of Medicines has the right to request additional information necessary for providing an opinion.

[16 July 2019]

10.⁶ If the documents referred to in Paragraphs 10.³ and 10.⁴ of this Regulation cannot be prepared in accordance with the laws and regulations regarding the drawing up of electronic documents, they shall be submitted in paper form and their electronic version shall be sent to the State Agency of Medicines.

[16 July 2019]

10.⁷ The expenses for providing opinions shall be covered by the applicant in accordance with the laws and regulations regarding the price list of paid services of the State Agency of Medicines.

[16 July 2019]

10.⁸ After registration of the application with the State Agency of Medicines, the applicant is no longer entitled to amend the information specified in the application on its own initiative.

[16 July 2019]

10.⁹ When preparing an opinion, the State Agency of Medicines shall perform the following activities:

10.⁹1. the therapeutic assessment and evaluation of:

10.⁹1.1. published clinical trials or joint clinical assessment reports developed in accordance with Article 9 of Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU in relation to the therapeutic effectiveness advantages within the pharmacotherapeutic group or diagnosis specified in the application in respect of mortality rate or time to disease progression, decrease in the frequency of chronic diseases, onset of disability, hospitalisation cases, improvement of health condition, compared to other available treatment methods;

10.⁹1.2. the compliance with specific disease treatment schemes developed by medical professional associations (hereinafter - the treatment schemes) and international treatment guidelines, and also assessments carried out in other countries;

10.⁹1.3. the place of the medicinal products in the treatment scheme of the particular disease (for example, the medicinal products of first and second choice, the target groups of patients);

10.⁹1.4. [16 July 2024];

10.⁹1.5. [16 July 2024];

10.⁹2. the economic assessment in accordance with the medicinal product economic assessment guidelines approved in Annex 3 to this Regulation;

10.⁹3. the evaluation of opinions provided by interested parties (including medical professional associations or medical treatment institutions and patient organisations), if such opinions have been received.

[16 July 2019; 16 July 2024]

10.¹⁰ The State Agency of Medicines shall indicate the following in its opinion:

10.¹⁰1. the name of the medicinal product, the common name of the medicinal product, the code of the medicinal product in the ATC/DDD classification, the pharmaceutical form and strength of the medicinal product, the method of administration of the medicinal product or information on the medical device;

10.¹⁰2. the disease and its diagnosis code according to the ICD and also the target patient group if the medicinal products or medical devices have been assessed for use in a specific patient group;

10.¹⁰3. the conclusion on the comparative effectiveness of the medicinal products or medical devices;

10.¹⁰4. the conclusion on the cost-effectiveness of the medicinal products or medical devices in the health care system;

10.¹⁰5. special considerations (if any) that must be taken into account when assessing the medicinal product or medical device for inclusion on the list of reimbursable medicinal products.

[16 July 2019; 16 July 2024]

10.¹¹ The State Agency of Medicines shall provide the opinion in the form of an electronic document, sending it to the applicant's email address within 120 days after receipt of the application, excluding the period required for receiving the additional information referred to in Paragraph 10.⁵ of this Regulation and the period from the drawing up of an invoice until payment thereof. If the applicant has not submitted all the documents and information necessary for providing an opinion or has not paid for the examination of the application in accordance with the laws and regulations regarding the price list of paid services of the State Agency of Medicines, the State Agency of Medicines shall not examine the application and shall inform the applicant accordingly.

[16 July 2019]

10.¹² The State Agency of Medicines shall publish information on the opinion on its website within five working days after sending the opinion to the applicant.

[16 July 2019]

III. Inclusion of Medicinal Products and Medical Devices on the List of Reimbursable Medicinal Products

11. In order to include medicinal products or medical devices on the list of reimbursable medicinal products, the applicant shall submit an application to the National Health Service. The application shall indicate:

11.1. information regarding the applicant (the name, registration number, legal address of the legal person) and the payer (settlement details);

11.2. information on the medicinal product or medical device (the name, registration number, registration date, manufacturer's price and intended basic reimbursement price, package size). The common name of the medicinal product, the medicinal product code in the ATC/DDD classification, the pharmaceutical form, and the strength of the medicinal product (amount of active substance per dose) shall also be indicated for medicinal products;

11.3. the disease, indicating the diagnosis code according to the ICD, and the target patient group (patient group with a specific diagnosis for which the use of the relevant medicinal products or medical devices is justified), for whose treatment the reimbursement of expenditures for the acquisition of medicinal products or medical devices is to be evaluated.

[16 July 2019]

12. The applicant shall append the following documents and information to the application for the inclusion of medicinal products on the list of reimbursable medicinal products:

12.1. the opinion of the State Agency of Medicines (if applicable), except for the following cases:

12.1.1. if the individual common names of medicinal products contained in the composition of a combination of the common names of medicinal products are included on the list of reimbursable medicinal products and the applicant applies for their reimbursement for the same diagnoses and patient groups for which the individual common names of medicinal products are reimbursed;

12.1.2. if medicinal products with the specific common name have already been submitted and assessed for the same diagnoses and patient groups for inclusion on the list of reimbursable medicinal products;

12.1.3. if an application is submitted for generic medicinal products in order to include a new common name of the medicinal product on the list of reimbursable medicinal products on the initiative of the National Health Service;

12.2. information on the sales price of the manufacturer of the medicinal products in the Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, Slovakia, and Hungary in the respective currency and in euros according to the foreign currency exchange rate used in accounting on the day of submission of the application;

12.3. the calculation of the anticipated consumption of funds granted for reimbursement, including the comparative therapy, target groups of patients and the number of patients, and also the calculation regarding the probable quantity and the estimated turnover of the medicinal products to be sold in Latvia in accordance with the procedures of reimbursement;

12.4. a certification that the continuous presence of the reimbursable medicinal products on the market will be ensured;

12.5. an authorisation issued by the holder (owner) of the marketing authorisation for medicinal products or the wholesaler of the medicinal products, if the applicant is the authorised representative of the holder (owner) of the marketing authorisation for medicinal products or the wholesaler of the medicinal products;

12.6. a document confirming that the applicant has been registered in any country of the European Economic Area and also a document confirming the right of representation (copies);

12.7. information on the financial participation of the applicant in the provision of medicinal products.

[16 July 2019; 26 March 2024]

13. Where medicinal products are being brought in and distributed in the territory of the Republic of Latvia in accordance with Section 10, Clause 7 of the Pharmaceutical Law, the applicant shall attach the following information to the application:

13.1. instructions on the use of the medicinal products in the official language and the original language;

13.2. the wholesale price in the currency of the state of manufacture and state of exportation and in euros in accordance with the foreign currency exchange rate to be used in accounting on the day when the application is submitted;

13.3. a certification that the continuous presence of the medicinal products on the market will be ensured;

13.4. the calculations regarding the probable amount of the medicinal products to be sold in Latvia in accordance with the procedures for reimbursement, the estimated turnover (in euros) and the number of patients per year;

13.5. an authorisation issued by the holder of the permit of the State Agency of Medicines for the bringing in of non-authorised medicinal products, where the application is being submitted by an authorised representative.

[25 August 2009; 10 September 2013]

14. Where the medicinal products are being distributed in parallel or parallel imported, an applicant shall attach the following information to the application:

14.1. the sales price of the manufacturer in the currency of the state of manufacture and state of exportation and in euros in accordance with the foreign currency exchange rate to be used in accounting on the day when the application is submitted;

14.2. a certification that the continuous presence of the medicinal products on the market will be ensured;

14.3. the calculations regarding the probable amount of the medicinal products to be sold in Latvia in accordance with the procedures for reimbursement, the estimated turnover (in euros) and the number of patients per year;

14.4. an authorisation issued by the parallel distributor or parallel importer, where the application is being submitted by the authorised representative.

[27 January 2009; 25 August 2009; 10 September 2013]

15. The applicant shall append the following documents and information to the application for the inclusion of medical devices on the list of reimbursable medical devices:

15.1. the opinion of the State Agency of Medicines (if applicable);

15.2. information on the sales price of the manufacturer of the medicinal products in the Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, Slovakia, and Hungary in the respective currency and in euros according to the foreign currency exchange rate used in accounting on the day of submission of the application;

15.3. the calculation of the anticipated consumption of funds granted for reimbursement, including the comparative therapy, target groups of patients and the number of patients, and also the calculation regarding the probable quantity and the estimated turnover of the medical devices to be sold in Latvia in accordance with the procedures of reimbursement;

15.4. a certification that the continuous presence of the reimbursable medical devices on the market will be ensured;

15.5. an authorisation issued by the manufacturer of medical devices, if the application is submitted by an authorised representative of the manufacturer;

15.6. a document confirming that the applicant has been registered in any country of the European Economic Area and also a document confirming the right of representation (copies);

15.7. a proposal for the financial participation of the applicant in the provision of medicinal products;

15.8. a description of the medical devices in Latvian;

15.9. a copy of the EC conformity declaration.

[16 July 2019]

16. The applicant shall append the following documents and information to the application for the re-examination of reimbursement conditions for medicinal products:

16.1. the opinion of the State Agency of Medicines (if applicable), except for the following cases:

16.1.1. if applying for the reimbursement of a combination of the common names of medicinal products for the same diagnoses and patient groups for which the individual common names of medicinal products are reimbursed;

16.1.2. if medicinal products with the specific common name have already been submitted and assessed for the same diagnoses and patient groups for inclusion on the list of reimbursable medicinal products;

16.1.3. if the common name of the medicinal product has already been included on the list of reimbursable medicinal products and the submitter applies to expand the compensation conditions with the cost minimisation method for the same diagnoses and/or patient groups in comparison to a medicinal product which has already been included on the list of reimbursable medicinal products and against which cost minimisation is being carried out;

16.2. the calculation of the anticipated use of funds granted for reimbursement, including the comparative therapy, target groups of patients and the number of patients, and also the calculation of the probable quantity and the estimated turnover of the medicinal products to be sold in Latvia in accordance with the procedures of reimbursement, if changing the prescription conditions or including the medicinal products in another list;

16.3. information on the sales price of the manufacturer of the medicinal products in the Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, Slovakia, and Hungary in the respective currency and in euros according to the foreign currency exchange rate used in accounting on the day of submission of the application.

[16 July 2019; 26 March 2024; 27 May 2025]

16.¹ The applicant shall append the following documents and information to the application for the re-examination of reimbursement conditions for medical devices:

16.¹1. a justification for re-examination of reimbursement conditions for the particular diagnosis or target group of patients or inclusion of the medical device on another list;

16.¹2. the calculation of the anticipated consumption of funds granted for reimbursement, including target groups of patients and the number of patients, and also the calculation regarding the probable quantity and the estimated turnover of the medical devices to be sold in Latvia in accordance with the procedures for reimbursement, in changing the prescription conditions;

16.¹3. information on the sales price of the manufacturer of the medicinal products in the Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, Slovakia, and Hungary in the respective currency and in euros according to the foreign currency exchange rate used in accounting on the day of submission of the application.

[25 August 2009; 10 September 2013; 21 October 2014; 16 July 2019; 16 July 2024]

16.² The applicant shall append the following documents and information to an application for the re-examination of the basic reimbursement price of medicinal products or medical devices:

16.²1. a justification based on calculations regarding the changes in the manufacturer's price or the basic reimbursement price. A justification for increase of the basic reimbursement price may be the growth of manufacturing costs, the changes in the currency exchange rate, the application of maximum mark-up of a wholesaler;

16.²2. the calculation of the anticipated consumption of funds granted for reimbursement after changing of the basic reimbursement price, including the comparative therapy, target groups of patients and the number of patients, and also the calculation regarding the probable quantity and the estimated turnover of the medicinal products and medical devices to be sold in Latvia in accordance with the procedures of reimbursement;

16.²3. information on the sales price of the manufacturer of the medicinal products in the respective currency in the Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, Slovakia, and Hungary and in euros according to the foreign currency exchange rate used in accounting on the day of submission of the application.

[25 August 2009; 10 September 2013; 21 October 2014; 16 July 2019]

16.³ In the application for the temporary reduction of the basic reimbursement price of medicinal products or medical devices, the applicant shall indicate the name of medicinal products or medical devices, the registration number, the common name of the medicinal product, the strength of the medicinal product, the pharmaceutical form of the medicinal product, the size of the packaging, the basic reimbursement price, the basic reimbursement price reduced temporarily envisioning a reduction of not less than 5 % or equal to the lowest price of medicinal products in reference groups without a reference product, and the time from which the reduced basic reimbursement price will be applied. The temporarily reduced basic reimbursement price and the pharmacy price calculated therefrom pursuant to Paragraph 28 of this Regulation of medicinal products and medical devices of List A may not be lower than the reference price already specified in the list of reimbursable medicinal products, or lower than the lowest offered price specified in accordance with Paragraph 62.² of this Regulation or equivalent thereto. The reduced basic reimbursement price shall be waived on the basis of the application of the applicant regarding the waiving of the reduced basic reimbursement price. If the reference medicinal products are deleted from the list of reimbursable medicinal products, the National Health Service shall increase the reduced basic reimbursement price so that it would conform to the criteria laid down in this Paragraph. If the increase in treatment costs after deletion of the reference medicinal product exceeds 30 %, the National Health Service is entitled to establish a reference price without taking into account the requirements specified in Paragraph 36 of this Regulation.

[26 March 2024]

17. The National Health Service, in addition to the documents and information referred to in Paragraphs 11, 12, 13, 14, 15, 16, 16.¹, 16.², and 16.³ of this Regulation, has the right to request additional information necessary for the taking of a decision.

[25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014]

18. The applicant shall be responsible for the veracity of the data included in the documents and information appended to the application. After registration of the application with the National Health Service, the applicant is not entitled to amend the information referred to in the application upon his or her own initiative. If the applicant wants to amend the information referred to in the application, the application shall be submitted anew. The previous application shall be cancelled (payment for the new application shall not be required).

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

18.¹ An applicant shall immediately notify the National Health Service, if the name, the registration number, the holder (owner) or his or her authorised representative of the registration certificate of the medicinal products or medical devices included on the list of reimbursable medicinal products, have been changed.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

19. After registration of the application, the National Health Service shall draw up an invoice in accordance with the price list for paid services of the National Health Service.

[25 August 2009; 22 September 2009; 19 October 2011; 16 July 2019]

20. The National Health Service has the right to waive the charge for the evaluation of medicinal products or medical devices necessary for the inclusion thereof on the list of reimbursable medicinal products or the charge for the evaluation of the revision of reimbursement conditions, or the annual charge for maintaining medicinal products and medical devices on the list of reimbursable medicinal products if:

20.1. the turnover of the relevant medicinal products or medical devices within the scope of reimbursement procedures in the previous year have not exceeded EUR 2845.74, but they are substantially necessary for the provision of the treatment process;

20.2. the medicinal products are brought in and distributed in the territory of the Republic of Latvia in accordance with Section 10, Clause 7 of the Pharmaceutical Law.

[27 May 2025]

21. If the National Health Service takes a decision to waive the charge referred to in Paragraph 20 of this Regulation, it shall not draw up an account for the performance of the relevant payment or shall cancel the account that has already been draw up. If the applicant has already paid for examination of the application or for the maintenance of the medicinal products or medical devices on the list of reimbursable medicinal products, he or she shall not be reimbursed the expenditure.

[27 May 2025]

22. When examining the application for the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, the National Health Service shall assess the following:

22.1. the prices of medicinal products and medical devices in comparison with the prices of the respective medicinal products and medical devices in the Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, Slovakia, and Hungary;

22.2. the treatment costs when using the relevant medicinal products or medical devices, and their impact on the funds granted for reimbursement.

[16 July 2019]

23. Medicinal products shall be included on List A and List B, if they comply with the following criteria in addition to the requirements referred to in Sub-paragraphs 6.1 and 6.2 and Paragraph 7 of this Regulation:

23.1. the therapeutic efficacy and advantages in the treatment of any of the diseases referred to in Annex 1 to this Regulation have been proved to the medicinal product;

23.2. the use of the medicinal product complies with the treatment scheme or international treatment guidelines of the particular disease;

23.3. the pharmaceutical form and strength complies with the treatment scheme;

23.4. the size of the packaging corresponds with the course of treatment;

23.5. the costs of use of the medicinal product can be foreseen and commensurable with the anticipated therapeutic efficacy and with the funding granted for reimbursement in the respective year.

24. Medical devices shall be included on Lists A and B, if they comply with the following criteria in addition to the requirements referred to in Sub-paragraphs 6.1 and 6.2 and Paragraph 9 of this Regulation:

24.1. the therapeutic efficacy and advantages in the treatment of any of the diseases referred to in Annex 1 to this Regulation have been proved to the medical device;

24.2. the costs of use of the medical device can be foreseen and commensurable with the anticipated therapeutic efficacy and with the funds granted for the reimbursement in the respective year.

25. Medicinal products, the efficacy of which is higher, in comparison with another type of efficient treatment of available costs, but the inclusion of which on the list of reimbursable medicinal products might cause additional expenses from the funds granted for reimbursement, shall be included on the list of reimbursable medicinal products, applying the prescription conditions, and also if it is allowed by the amount of the funds granted for the reimbursement.

26. The basic reimbursement price (sales price of the wholesaler) for reimbursable medical devices and any medical devices to be partially or completely covered from the State budget funds shall not exceed the price that is obtained by using the following formula:

KBC = KMRC + LP, where

KBC - the basic reimbursement price of the reimbursable medical devices (in euros);

KMRC - the manufacturer's price of the reimbursable medical devices (in euros);

LP - wholesale mark-up in per cent (Annex 4).

[16 July 2024]

27. [15 May 2012]

28. The pharmacy price of reimbursable medical devices and any medical devices to be partially or completely covered from the State budget funds shall be calculated by using the following formula:

KMAC = KBC x k + X + PVN where

KMAC - the pharmacy price of the reimbursable medical devices (in euros);

KBC - the basic price of reimbursement in euros;

k - the correction coefficient (Annex 5);

X - the correction amount (in euros) (Annex 5);

PVN - the calculated value added tax.

[16 July 2024]

29. A patient shall cover the difference between the pharmacy price of medicinal products or medical devices and the reimbursement sum or the third party or applicant - in the cases referred to in Paragraph 100.¹ of this Regulation.

[9 October 2012]

29.¹ Medicinal products and medical devices included on the list of reimbursable medicinal products shall be distributed in pharmacies only for the pharmacy price determined by the National Health Service, taking into account the procedures referred to in this Regulation.

[26 May 2015]

29.² [16 July 2024]

30. The price of reimbursable medicinal products or medical devices shall not be higher than the second lowest sales price of the manufacturer and the wholesale price of the medicinal products or medical devices in the Czech Republic, Denmark, Poland, Romania, Slovakia, and Hungary and shall not exceed the sales price of the manufacturer and the wholesale price of the medicinal products or medical devices in Estonia and Lithuania. The applicant shall, each year by 1 February, submit electronically to the National Health Service the information on the current prices of medicinal products (in euros) in the abovementioned countries (Annex 8) and indicate them also in the currency of the relevant country, if necessary. If the approved basic reimbursement price does not conform to the abovementioned requirements, the applicant shall simultaneously submit the application for a reduction of the basic reimbursement price.

[26 March 2024]

30.¹ The price of parallel distributed and parallel imported medicinal products shall be lower than the price of such reimbursable medicinal products, in relation to which parallel distribution or parallel importation has been carried out. The prices of other reimbursable medicinal products and medicinal products to be included on the list of reimbursable medicinal products shall not be compared to the prices of parallel distributed or parallel imported medicinal products.

[26 May 2015]

31. [27 May 2025]

31.¹ The applicant shall immediately inform the National Health Service of any interruption in the supply of medicinal products or medical devices and the expected duration thereof. Simultaneously, the applicant is entitled to submit an application to the National Health Service requesting not to remove the medicinal products or medical devices from the list of reimbursable medicinal products for a period of up to six months during the supply interruption. The National Health Service shall electronically notify the State Agency of Medicines of the information provided by the applicant.

[30 June 2020]

IV. Inclusion of Medicinal Products and Medical Devices on List A and the Determination of the Reference Price

32. The medicinal products shall be included on List A:

32.1. within the scope of one common medicinal product name with the same type of administration and medical devices with the same type of use (medicinal products within the scope of one common name are considered as medicinal products of equal therapeutic efficacy, except in cases when as a result of clinic researches submitted by the applicant clinically significant differences in terms of therapeutic efficacy or adverse effects are proven compared to other medicinal products of the same common name included on the list of reimbursable medicinal products);

32.2. within the scope of pharmaco-therapeutic groups of the medicinal products (three to seven symbols in the ATC/DDD classification) if:

32.2.1. therapeutic efficacy of the medicinal products has been proved for the treatment of the same disease referred to in Annex 1 to this Regulation;

32.2.2. there are no clinically significant differences, taking into account the data of the clinical trials, therapeutic efficacy and adverse effects;

32.3. they are medicinal products of combined composition, the composition of which includes common medicinal product names or common medicinal product names of equal therapeutic efficacy included on the list of reimbursable medicinal products and advantages of the medicinal products of combined composition have not been proved in the clinical trials of the medicinal products within the meaning of therapeutic efficacy and adverse effects, in comparison with medicinal products to be used individually included in the composition thereof.

[27 March 2007; 25 August 2009; 9 October 2012; 7 August 2018]

33. Medicinal products on List A shall be classified in groups of equal therapeutic efficacy medicinal products, taking into account the pharmaceutical form, the strength of the medicinal products. The medicinal products which are intended for the commencement of therapy or for dosage titration (gradual diminishing or amplification of dosage of medicinal products) shall be classified in one group with the medicinal products of the nearest strength.

[25 August 2009; 20 September 2016 / Amendment to the first sentence of this Paragraph with regard to the deletion of words "and also the compliance of the size of packaging with the treatment course" shall come into force on 1 April 2017. See Paragraph 2 of the amendments]

34. Medical devices on List A shall be classified in groups, taking into account their type of use.

[25 August 2009]

35. For each group of medicinal products or medical devices included on List A shall be calculated a reference price, which is the pharmacy price of the cheapest medicinal product or the cheapest medical device of an equal therapeutic efficacy group. The reference price shall be the ground for the calculation of the reimbursement sum.

[25 August 2009; 19 October 2011; 27 December 2011; 9 October 2012; 26 May 2015]

36. In order to calculate the reference price for the medicinal product and medical device included on List A, the following principles shall be applied:

36.1. the reference price shall be calculated for each medicinal product name, including the pharmaceutical form, strength, and for each medical device name;

36.2. the reference price shall be calculated for each medicinal product name on the basis of the treatment costs of the reference medicinal product name of equal therapeutic efficacy group in accordance with the daily dosage defined in the ATC/DDD classification, taking into account the pharmaceutical form, strength and size of the packaging;

36.3. if in accordance with the submitted clinical documentation the therapeutic daily dosage of medicinal products does not comply with the defined daily dosage in the ATC/DDD classification, the reference price shall be calculated on the basis of the therapeutic daily dosages;

36.4. the costs of one unit of different forms of medicinal products may differ from the costs of the tablet and capsule form of the medicinal products in accordance with the maximum admissible difference in costs indicated in Annex 6 to this Regulation;

36.5. the unit price of the one common name medicinal product with the stronger active substance shall be less than the unit price of the nearest medicinal product with the active substance of less strength;

36.6. [20 September 2016 / See Paragraph 2 of Amendments];

36.7. the costs of medicinal products of combined composition may not exceed the amount of the cost of the cheapest medicinal product under the same common medicinal product name or common medicinal name of equal therapeutic efficacy included on the list of reimbursable medicinal products to be utilised separately.

[27 January 2009; 25 August 2009; 20 September 2016 / Amendment to Sub-paragraph 36.1 with regard to the deletion of words "and size of packaging" and amendment regarding deletion of Sub-paragraph 36.6 shall come into force on 1 April 2017. See Paragraph 2 of the amendments]

36.¹ Within the scope of one reimbursement group the reimbursement price may be determined for several medicinal products or medical devices.

[26 May 2015]

36.² For medicinal products with the same common name or medical devices with the same method of use included in List A, the pharmacy price must not exceed a 100 % price difference threshold compared to the lowest pharmacy price of medicinal products or medical devices in the respective group, calculated according to the defined daily dose in the ATC/DDD classification or, if such is not specified, according to the therapeutic daily dose if there are more than two medicinal products in the respective group of medicinal products.

[16 July 2019]

37. The reimbursement sum for the medicinal products and medical devices included on List A shall form by applying the reimbursement sum specified in Annex 1 to this Regulation to the reference price.

37.¹ In reviewing the reference price of the medicinal products or medical devices included on List A in accordance with the justification indicated in Paragraph 38 of this Regulation, the National Health Service shall indicate the relevant changes in the list of reimbursable medicinal products in the decision on such medicinal products or medical devices which cause changes to the reference price, without making amendments to decisions on other medicinal products or medical devices included in the relevant reference group (hereinafter - the non-reference medicinal products or medical devices).

[29 March 2011; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

38. The National Health Service shall revise the reference price of medicinal products and medical devices included on List A or the basic reimbursement price on the basis of:

38.1. the applicant's application to which the documents and information referred to in Paragraphs 16.² and 16.³ of this Regulation are appended;

38.2. a decision to include such medicinal products or medical devices on the list of reimbursable medicinal products, by using which the treatment costs are lower than the costs of medicinal products or medical devices already included on the list of reimbursable medicinal products;

38.3. the report of the Health Inspectorate or the information from the information system of the State Agency of Medicines that the reference medicinal products or reference medical devices are not permanently available on the market. In such case the reference price shall be re-calculated taking into account the following cheapest medicinal product or medical device price of the relevant group of medicinal products or medical devices of an equal therapeutic efficacy;

38.4. a decision to delete reference medicinal products and reference medical devices from the list of reimbursable medicinal products;

38.5. the classification in groups performed for the calculation of the reference price.

[1 April 2008; 27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 26 March 2024]

38.¹ The National Health Service shall take a decision not to increase the basic reimbursement price of medicinal products and medical devices included on List A if:

38.¹1. the applicant has not provided a justification based on calculations for the increase of price;

38.¹2. due to revision of the price the foreseeable increase of costs is not commensurable with the funds granted for reimbursement;

38.¹3. the sales amounts of the respective medicinal products or medical devices within the scope of reimbursement procedures have increased by more than 10 % in the preceding year and reimbursement of such medicinal products and medical devices to patients with other diagnoses has not been started or the prescription conditions have been changed;

38.¹4. the manufacturer's price or the basic reimbursement price of medicinal products or medical devices is higher than the second lowest sales price of the manufacturer or the wholesale price of the medicinal products or medical devices in the Czech Republic, Denmark, Romania, Poland, Slovakia, and Hungary or exceeds the sales price of the manufacturer and the wholesale price of these medicinal products or medical devices in Estonia and Lithuania;

38.¹5. the decision to increase the basic reimbursement price has been taken within the last 12 months.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014; 16 July 2019; 26 March 2024]

38.² If the applicant applies to reduce the basic reimbursement price of the medicinal products or medical devices included on List A, determining it lower than the basic reimbursement price of the reference medicinal products and medical devices present in the relevant reference group, the basic reimbursement price of these medicinal products or medical devices shall be at least 5 % lower than the basic reimbursement price of the reference medicinal products or medical devices present in the relevant reference group on List A.

[27 December 2011; 7 August 2018]

38.³ If the applicant applies for inclusion of new medicinal products in List A and the National Health Service takes the decision referred to in Paragraph 45 of this Regulation to include the medicinal products from List B on List A or the decision referred to in Paragraph 50.¹ of this Regulation to include medicinal products from List C on List A, the basic reimbursement price for the new reference medicinal products within the scope of one common medicinal product name shall be by at least 30 % lower than the basic reimbursement price of the medicinal products of List B or List C, and the treatment cost for a patient per year shall be by at least 10 % lower. The basic reimbursement price of the subsequent two medicinal products to be included in List A within the scope of one common medicinal product name shall be by at least 10 % lower than the basic reimbursement price of the reference medicinal products or the cheaper medicinal products present on the relevant reference group on List A. Henceforth, the basic reimbursement price of medicinal products to be included in List A within the same common name must be by at least 5 % lower than the basic reimbursement price of the reference or cheapest medicinal products in the relevant reference group of List A; however, if there are at least five medicinal products within the relevant reference group in the list of reimbursable medicinal products, then the basic reimbursement price of the next medicinal products to be included may be equal to the basic reimbursement price of the existing reference or cheapest medicinal products.

[26 March 2024]

38.⁴ If the National Health Service has received the application referred to in Paragraph 31.¹ of this Regulation and if the relevant reference medicinal products or medical devices are not available at medicinal product wholesalers, during this period the National Health Service shall designate the next cheapest reimbursable medicinal products or medical devices of the relevant group available in the market in Latvia as reference medicinal products or medical devices.

[30 June 2020]

38.⁵ [27 December 2011]

38.⁶ If the applicant applies inclusion of a new medical device on List A of reimbursable medicinal products, the basic reimbursement price of such medical device must be at least 5 % lower than the basic reimbursement price of the reference medical devices present in the relevant reference group of List A. If there are at least five medical devices within the relevant reference group in the list of reimbursable medicinal products, then the basic reimbursement price of the next medical devices to be included may be equal to the basic reimbursement price of the existing reference or cheapest medical devices.

[26 March 2024]

V. Inclusion of Medicinal Products and Medical Devices on List B

39. Medicinal products shall be included on List B if in addition to the criteria referred to in Paragraph 23 of this Regulation the price of the medicinal products is justified by calculations performed in accordance with the guidelines for the economic assessment of medicinal products included in Annex 3 to this Regulation. The calculations include the costs for one unit of an additionally obtained result of therapeutic efficacy (incremental cost-effectiveness ratio) - for a life-year gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year. The cost-effectiveness of the medicinal products shall be proved in relation to the health care system at large or a specific group of patients. The incremental cost-effectiveness ratio for an additionally gained life-year, a life-year without progression of the disease or quality-adjusted life year shall not exceed triple gross domestic product per capita in the previous year or in the last year for which the data is available (the data available on the website of the Central Statistical Bureau regarding the gross domestic product in current prices).

[7 August 2018]

40. The reimbursement sum for the medicinal products and medical devices included on List B shall form by applying the reimbursement sum specified in Annex 1 to this Regulation to the pharmacy price.

41. In determining the basic reimbursement price of medicinal products to be included on List B, costs of medicinal products within the scope of one common medicinal product name shall be assessed and the following conditions shall be taken into account:

41.1. the costs of different forms of medicinal products may differ from the costs of the tablet and capsule form of the medicinal products in accordance with the maximum difference of costs indicated in Annex 6 to this Regulation, calculating according to the daily therapeutic dosage of the medicinal products as defined in the ATC/DDD classification. If according to the submitted clinical documentation the therapeutic daily dosage does not comply with the defined daily dosage in the ATC/DDD classification, the price shall be calculated on the basis of dosages referred to in the submitted clinical documentation;

41.2. the unit price of a medicinal product with a stronger active substance shall be lower than the unit price of the nearest medicinal product with the active substance of less strength;

41.3. the unit price of a medicinal product of equal strength with a larger number of units in a packaging shall be less than the unit price of the nearest smaller packaging medicinal product;

41.4. [27 March 2007].

42. [7 August 2018]

43. The National Health Service has the right to revise the approved basic reimbursement price of medicinal products and medical devices included on List B in the following cases:

43.1. the applicant's application, to which the documents and information referred to in Paragraph 16.² of this Regulation are appended, has been received;

43.2. the increase of the sales amount exceeds more than 10 % a year, except in cases where reimbursement of such medicinal products and medical devices to patients with other diagnoses has been started or the prescription conditions have been changed in the indicated period of time;

43.3. medicinal products or medical devices of therapeutic or superior efficacy with lower costs have been included on the list of reimbursable medicinal products.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 26 March 2024]

44. The National Health Service shall take a decision not to increase the basic reimbursement price of medicinal products and medical devices included on List B if:

44.1. the applicant has not submitted a corresponding justification based on calculations for the increase of the price;

44.2. the sales amounts of the respective medicinal products or medical devices within the scope of reimbursement procedures have increased by more than 10 % in the preceding year and reimbursement of such medicinal products and medical devices to patients with other diagnoses has not been started or the prescription conditions have been changed;

44.3. medicinal products or medical devices of equal therapeutic efficacy with lower costs are on the list of reimbursable medicinal products;

44.4. due to revision of the price the foreseeable increase of costs is not commensurable with the funds granted for reimbursement;

44.5. the manufacturer's price or the basic reimbursement price of medicinal products or medical devices is higher than the second lowest sales price of the manufacturer or the wholesale price of the medicinal products or medical devices in the Czech Republic, Denmark, Romania, Poland, Slovakia, and Hungary or exceeds the sales price of the manufacturer or the wholesale price of these medicinal products or medical devices in Estonia and Lithuania;

44.6. the decision to increase the basic reimbursement price has been taken within the last 12 months.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014; 16 July 2019; 26 March 2024]

44.¹ If the applicant applies to reduce the basic reimbursable price of medicinal products included on List B within two years before expiry of the patent protection, the reduction of the price shall be at least by 20 %.

[28 December 2010; 19 October 2011; 21 October 2014; 26 May 2015]

44.² If the basic reimbursement price of medicinal products or medical devices is reduced for a period on the basis of the application referred to in Paragraph 16.³ of this Regulation, the requirements of Paragraph 44.¹ of this Regulation shall not be applied.

[29 March 2011; 30 June 2020]

45. The National Health Service shall take a decision to include the medicinal products and medical devices, which are on List B, on List A, if a decision to include a new medicinal product name of equal therapeutic efficacy, common medicinal product name or new medical devices with the same indication of the use and type of the use on the list of reimbursable medicinal products has been taken. If in re-assessing the conformity of the medicinal products and medical devices included on the list of reimbursable medicinal products with the requirements and criteria referred to in this Regulation, the National Health Service establishes that the common name of a medicinal product of equal therapeutic efficacy or a medical device with the same type of the use is on the list of reimbursable medicinal products, the National Health Service shall take a decision to include the medicinal products or medical devices currently on List B on List A.

[25 August 2009; 22 September 2009; 8 June 2010; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

45.¹ The National Health Service shall inform the applicant of the excess of the increase in the sales volume if, when performing an annual data analysis, the National Health Service establishes that the increase in the sales volume of the particular medicinal products or medical devices included in List B, the reimbursement of the acquisition expenditures of which has been commenced at least three years before, exceeds 10 % of the relevant indicator of the previous period, except for the cases where the contract referred to in Sub-paragraph 61.2.4 of this Regulation or a sales volume contract has been entered into or the reimbursement of the acquisition expenditures of such medicinal products or medical devices for patients with other diagnoses has been commenced in the previous year, or the prescription conditions have been changed, or there exist any other objective circumstances. If the applicant does not enter into the contract referred to in Sub-paragraph 61.2.4 of this Regulation or a sales volume contract within two months from receipt of information from the National Health Service, but the increase in the sales volume exceeds 10 % the National Health Service shall take a decision and write out an invoice regarding the payment to be made. The amount of the payment shall be determined, using the following formula:

P = PA_x - (PA_y+10 %) - PVN - AU - LU where

P - the amount of the payment;

PA_x - the sales volume in the previous year;

PA_y - the sales volume prior to the previous year;

PVN - the calculated value added tax;

AU - the amount of the pharmacy mark-up which has been calculated in accordance with the laws and regulations regarding the principles for the creation of prices for medicinal products;

LU - the amount of the wholesaler mark-up which has been calculated in accordance with the laws and regulations regarding the principles for the creation of prices for medicinal products.

[27 May 2025]

VI. Inclusion of Medicinal Products and Medical Devices on List C

46. Medicinal products and medical devices shall be included in List C if they meet the conditions referred to in Sub-paragraph 6.3, Paragraphs 39 and 41 of this Regulation and the following criteria:

46.1. the medicinal products or medical devices have proven therapeutic efficacy in the reduction of mortality or consequences of life-threatening diseases or diseases causing irreversible disability;

46.2. the incremental cost-effectiveness ratio for an additionally gained life-year, a life-year without progression of the disease or quality-adjusted life year shall not exceed triple gross domestic product per capita in the previous year or in the last year for which the data is available (the data available on the website of the Central Statistical Bureau regarding the gross domestic product in current prices);

46.3. the number of patients who need reimbursement of expenses towards the purchase of the relevant medicinal products or medical devices can be foreseen.

[26 March 2024]

47. [26 March 2024]

48. [26 March 2024]

49. [26 March 2024]

50. The National Health Service has the right to take the decision on the inclusion of medicinal products and medical devices from List C on List B if a financial participation offer or the offer referred to in Sub-paragraph 61.²4 of this Regulation to enter into a contract for financial participation in the provision of reimbursement, which does not include the supply of specific medicinal products or medical devices free of charge to the medical treatment institution and does not increase the cost of therapy, has been received.

[26 March 2024]

50.¹ The National Health Service has the right to take the decision on the inclusion of medicinal products and medical devices from List C on List A in one of the following cases:

50.¹1. an application for the inclusion of medicinal products of equal therapeutic efficacy or medical devices with the same type of the use on the list of reimbursable medicinal products has been received and the prescription conditions referred to in Paragraph 55 of this Regulation are sufficient in order to restrict the number of patients according to the funds granted for reimbursement;

50.¹2. an application for the inclusion of medicinal products of equal therapeutic efficacy or medical devices with the same type of use on the list of reimbursable medicinal products with an offer of the applicant to enter into a contract regarding financial participation in the provision of reimbursement in accordance with the procedures referred to in Sub-paragraph 61.²4 of this Regulation has been received and the prescription conditions referred to in Paragraph 55 of this Regulation are sufficient in order to restrict the number of patients according to the funds granted for reimbursement.

[21 October 2014]

51. The National Health Service has the right to review the basic reimbursement price and reimbursement conditions of medicinal products and medical devices included on List C, if the information regarding changes in prices for these medicinal products and medical devices in other states is at the disposal of the National Health Service.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

52. The reimbursement sum for the medicinal products and medical devices included on List C shall be formed by applying the reimbursement sum specified in Annex 1 to this Regulation to the pharmacy price.

VI.¹ Inclusion of Medicinal Products and Medical Devices on List R

[21 December 2021]

52.¹ Diagnoses of rare diseases shall be included on List R of reimbursable medicinal products. List R shall be drawn up, maintained, and published on the website by the National Health Service. The list of diagnoses shall be updated as necessary, but not less than once every six months.

[21 December 2021]

52.² The National Health Service has the right to decide on the inclusion of medicinal products intended for the treatment of rare diseases on List A, B, C, or R of reimbursable medicinal products. The National Health Service shall examine the proposal for the inclusion of medicinal products on List R at a committee meeting, inviting experts from the State Agency of Medicines, clinical university hospital medical specialists, and representatives of patient organisations.

[21 December 2021]

52.³ The committee established by the National Health Service shall assess the medicinal products and decide on their inclusion on List R, taking into account the following criteria:

52.³1. the justification for the necessity of the specific medicinal therapy;

52.³2. the place of medicinal therapy in treatment;

52.³3. the criteria for initiating and discontinuing therapy;

52.³4. the total number of patients and the funds granted in the respective year for the treatment of rare diseases.

[21 December 2021]

52.⁴ If several applicants have submitted applications for the same common medicinal product name, the National Health Service shall take a favourable decision on the most economically advantageous offer, taking into account the treatment costs of one patient and the total number of patients to whom it is possible to ensure reimbursement of medicinal products within a calendar year.

[21 December 2021]

52.⁵ The National Health Service has the right to revise the basic reimbursement price or reimbursement conditions of medicinal products included on List R if there is information at the disposal of the National Health Service on changes in the prices of these medicinal products in other European Union Member States.

[21 December 2021]

52.⁶ The National Health Service has the right to remove medicinal products from List R if the actual circumstances of the case have changed or an opinion has been received from medical specialists in the relevant field of rare diseases that the medicinal products are not necessary for the treatment of a specific rare disease or the respective (new) therapy has lost its relevance, or additional budget resources are required and no opinion has been received from medical specialists in the relevant field of rare diseases on the necessity of reimbursement for the respective medicinal products. The National Health Service shall examine the proposal for deleting medicinal products from List R at a committee meeting which shall include experts from the State Agency of Medicines, clinical university hospital medical specialists, and representatives of patient organisations.

[21 December 2021]

VII. Taking and Announcement of Decisions

53. The National Health Service shall examine the application for the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, revision of reimbursement conditions, or inclusion of medicinal products on another list and take a decision within 60 days after registration of the application, excluding the period required for receiving the additional information referred to in Paragraph 17 of this Regulation and the period from the drawing up of an invoice until payment thereof (if the applicant has not paid for the examination of the application within one month after sending the invoice, the National Health Service shall not examine the application and shall inform the applicant thereof). While examining the application, the belonging of medicinal products and medical devices to List A, B, C or R, the basic reimbursement price and the pharmacy price for all medicinal products and medical devices to be included shall be determined, and also the reference price for medicinal products and medical devices to be included on List A shall be calculated.

[21 December 2021]

54. The National Health Service shall examine the application for the revision of the basic reimbursement price of medicinal products and medical devices and take a decision within 90 days after registration of the application, excluding the period required for receiving additional information.

[25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014; 16 July 2019]

55. The National Health Service shall take a decision on the diseases and medicinal products included on List R referred to in Annex 1 to this Regulation for the treatment of which expenditures for the acquisition of medicinal products or medical devices will be reimbursed from the funds granted for reimbursement. Limitations for prescribing or prescription conditions of reimbursable medicinal products or medical devices shall be determined in the following cases:

55.1. the reimbursement of medicinal products or medical devices is clinically justified and costs are efficient only to a specific target group of patients;

55.2. the advantages of such medicinal products have been proved to a specific group of patients in the clinical trials of the medicinal products, but costs of the medicinal products are higher than the costs of other medicinal products in the respective pharmaco-therapeutic group of medicinal products (three-five symbols in the ATC/DDD classification);

55.3. supervision of a specific expert is required for the use of the medicinal products, thus administration thereof is within the competence of an expert of the relevant treatment field (the expert determines the treatment, but henceforth the medicinal products may be prescribed and use thereof may be monitored by a family doctor) or only an expert is entitled to prescribe the medicinal products;

55.4. the anticipated costs of reimbursement of medicinal products or medical devices increase the funding granted for reimbursement for the acquisition of medicinal products in the respective year.

[21 December 2021]

56. The National Health Service shall take the decision on the revision of reimbursement conditions in accordance with the requirements and criteria specified in this Regulation and also the impact assessment on the funds granted for reimbursement from the State budget.

[16 July 2019]

56.¹ A decision to revise reimbursement conditions of medical devices shall be taken in accordance with the requirements and criteria specified in this Regulation, and also taking into account the submitted justification for the revision of reimbursement conditions and by evaluating the impact on the funds granted for reimbursement.

[25 August 2009]

57. In addition to the information specified in the Administrative Procedure Law the following information shall be indicated in the decision to include medicinal products and medical devices on the list of reimbursable medicinal products:

57.1. the time period of inclusion of the medicinal products or medical devices (the time period, during which the medicinal products or medical devices are on the list of reimbursable medicinal products), if the medicinal products or medical devices are included for a specified time period;

57.2. the basic reimbursement price and the pharmacy price of the medicinal products or medical devices, also the reference price - for List A;

57.3. the diseases, for the treatment of which expenditures for the acquisition of the particular medicinal products and medical devices will be reimbursed;

57.4. the prescription conditions of the particular medicinal products or medical devices (if required in accordance with Paragraph 55 of this Regulation);

57.5. the time of coming into force of the decision.

[25 August 2009]

58. [21 December 2021]

59. [26 March 2024]

60. [21 December 2021]

61. Medicinal products and medical devices for the treatment of particular diseases shall be included on the list of reimbursable medicinal products for an indefinite period of time (except the cases when the time period for inclusion is determined initially) until taking of a decision to delete medicinal products or medical devices from the list of reimbursable medicinal products.

[25 August 2009]

61.¹ The National Health Service shall evaluate the conditions for the reimbursement of medicinal products and medical devices included on the list of reimbursable medicinal products and take the decision to revise the conditions for the reimbursement of medicinal products and medical devices on the basis of the therapeutic effectiveness and economic efficiency assessment of medicinal products or medical devices, and also the evaluation of the impact on the funds granted for reimbursement.

[16 July 2024]

61.² The National Health Service has the right:

61.²1. to repeatedly assess the compliance of medicinal products and medical devices included on the list of reimbursable medicinal products with the requirements and criteria specified in this Regulation. If the National Health Service determines non-compliance of medicinal products or medical devices with this Regulation, it shall send a notification to an applicant. If the National Health Service establishes any non-conformity when repeatedly assessing the conformity of medicinal products or medical devices included on the list of reimbursable medicinal products with the requirements referred to in Paragraph 30 of this Regulation, the National Health Service has the right to determine the price of such medicinal products or medical devices for a period of up to two years, unless the applicant has proved that the indicated prices correspond to the actual prices at the time of assessment in the countries referred to in Paragraph 30 of this Regulation or has indicated considerations of expediency in relation to the right of the patient to receive therapy subject to complete or partial reimbursement. The price shall be reduced to the second lowest sales price of the manufacturer or wholesale price in the Czech Republic, Denmark, Romania, Poland, Slovakia, and Hungary or to the sales price of the manufacturer or wholesale price of such medicinal products or medical devices in Estonia and Lithuania depending on which price is the lowest. In the case of a price increase, if non-conformity with the requirements referred to in Paragraph 30 of this Regulation is established in the period of six months, the National Health Service has the right to revoke the decision taken in relation to the price increase;

61.²2. to include medicinal products and medical devices on the list of reimbursable medicinal products for a definite time period;

61.²3. on the basis of the application referred to in Paragraph 16.³ of this Regulation, take a decision to reduce the basic reimbursement price and the pharmacy price of reimbursable medicinal products or medical devices for a definite time period;

61.²4. after evaluation of proposals by the applicant to enter into a contract with the applicant regarding financial participation in the ensuring of reimbursement of medicinal products included on the list of reimbursable medicinal products, and also in the ensuring of reimbursement for individual persons;

61.²5. to establish the procedures for the provision of parenteral medicinal products in general or open-type pharmacies or also closed-type or medical treatment institution pharmacies, or to include parenteral medicinal products in the centralised procurement of medicinal products;

61.²6. in exceptional cases, in case of failure to comply with Paragraph 30 of this Regulation, to take the decision on the inclusion or retention of medicinal products on the list of reimbursable medicinal products, taking into account considerations of expediency and the right of the patient to receive therapy subject to complete or partial reimbursement.

[25 August 2009; 22 September 2009; 29 March 2011; 19 October 2011; 27 December 2011; 9 October 2012; 21 October 2014; 16 July 2019; 26 March 2024 / Sub-paragraph 61.²5 shall come into force on 1 July 2024. See Paragraph 3 of Amendments]

62. The National Health Service shall not include medicinal products and medical devices on the list of reimbursable medicinal products and revise reimbursement conditions on the initiative of the applicant if:

62.1. the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products or revision of reimbursement conditions does not comply with the requirements and criteria referred to in this Regulation;

62.2. the supplementary resources of the State budget are required for inclusion of the medicinal products or medical devices on the list of reimbursable medicinal products, but they are not commensurable with the funds granted for the reimbursement in the relevant year;

62.3. the use of the medicinal products or medical devices fails to comply with outpatient medical treatment;

62.4. when evaluating the place of the medicinal products in therapy, the required additional budget funds, the number of patients and other applications for the inclusion of medicinal products on the list for a specific diagnosis, an opinion has been received from the association of medical specialists in the relevant field that the medicinal products submitted for inclusion on the list of reimbursable medicinal products are no longer necessary.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 21 December 2021]

62.¹ The National Health Service shall introduce the changes in the list of reimbursable medicinal products resulting in the change in the reference price of the medicinal products and medical devices included on List A of reimbursable medicinal products four times a year - on 1 January, 1 April, 1 July, and 1 October. Other changes in the list of reimbursable medicinal products shall be introduced by the National Health Service once a month - on the first date of each month.

[7 August 2018]

62.² To revise the basic reimbursement price in accordance with Paragraph 38.² of this Regulation, the application for the revision of the basic reimbursement price shall be submitted until 30 September (if changes are intended from 1 January), until 30 December (if changes are intended from 1 April), until 31 March (if changes are intended from 1 July), and until 30 June (if changes are intended from 1 October). If changes are planned in accordance with the information to be submitted as referred to in Paragraph 30 of this Regulation by 1 February, determining a lower basic reimbursement price than the basic reimbursement price of the reference medicinal products or medical devices in the respective reference group, the changes in the list of reimbursable medicinal products shall be implemented from 1 April.

[21 December 2021]

62.³ The applicant shall, on its own initiative, submit the application for the revision of the basic reimbursement price of medicinal products and medical devices included on the list of reimbursable medicinal products without affecting the reference price or the application for the temporary reduction of the basic reimbursement price at least 45 days prior to the first date of the month during which the changes are intended to come into effect.

[16 July 2019]

62.⁴ The procedure referred to in Paragraph 62.² of this Regulation shall not be applied for the revision of the basic reimbursement price with temporary reduction.

[26 June 2012; 30 June 2020]

62.⁵ Information regarding the received applications for the inclusion of medicinal products and medical devices into the list of reimbursable medicinal products, and also for the revision of the basic reimbursement price shall be posted by the National Health Service, within three working days after the receipt of the application, on its website under the section "Reimbursable medicinal products".

[7 August 2018]

63. The National Health Service shall take a decision to delete medicinal products and medical devices from the list of reimbursable medicinal products if:

63.1. the medicinal products and medical devices have been withdrawn from the market or the distribution thereof has been prohibited in accordance with the procedures laid down in laws and regulations on the distribution of medicinal products;

63.2. the basic price of reimbursement is not complied with, which is confirmed by a report of the Health Inspectorate;

63.3. the applicant does not ensure the continuous availability of reimbursable medicinal products or reimbursable medical devices on the market, except for the cases where the National Health Service has received the application referred to in Paragraph 31.¹ of this Regulation;

63.4. the applicant has not paid the account for the maintenance of the medicinal products and medical devices on the list of reimbursable medicinal products within two months after the receipt of the account;

63.5. the applicant has submitted an application for the deletion of the medicinal products or medical devices from the list of reimbursable medicinal products;

63.6. the applicant does not fulfil the conditions of the decision referred to in Paragraph 57 of this Regulation or the conditions of the contract entered into with the National Health Service referred to in Sub-paragraph 61.24 of this Regulation;

63.7. the applicant does not submit an application for the elimination of non-compliance within a month after sending of the warning of the National Health Service referred to in Sub-paragraph 61.² 1 of this Regulation;

63.8. the increase in the sales volume of particular medicinal products or medical devices included on List B of the applicant exceeds 10 % from the sales volume of the previous period and the applicant has not entered into the contract referred to in Sub-paragraph 61.²4 of this Regulation or has not performed the payment referred to in Paragraph 45.¹ of this Regulation;

63.9. a substantiated opinion has been received from the association of medical specialists in the relevant field that it is no longer necessary to maintain the specific medicinal products on the list of reimbursable medicinal products.

[1 April 2008; 25 August 2009; 22 September 2009; 28 December 2010; 19 October 2011; 21 October 2014; 7 August 2018; 30 June 2020; 26 March 2024]

64. The National Health Service shall inform the applicant in writing within 10 days after taking the decision and shall publish the relevant information on the website of the National Health Service.

[21 December 2021]

64.¹ The National Health Service shall notify electronically the decision on the medicinal products or medical devices which caused changes in the reference price to the applicants of non-reference medicinal products or medical devices.

[29 March 2011; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

64.² The National Health Service shall notify the decision referred to in Sub-paragraph 61.²3 of this Regulation to reduce the basic reimbursement price and the pharmacy price for a specific period to the applicant, the Health Inspectorate, pharmacies which are engaged in a contractual relationship with the National Health Service, and medicinal product wholesalers electronically not later than 15 days before the application of the reduced price, without making any changes in the list of reimbursable medicinal products.

[21 December 2021]

64.³ The National Health Service shall, 15 days prior to the day of entering into effect of the updated list of reimbursable medicinal products, post the new list of reimbursable medicinal products on the website with an indication as to the date of entry into effect thereof, without indicating the basic reimbursement price temporarily reduced in accordance with Paragraph 16.³ of this Regulation.

[26 May 2015]

65. The applicant has the right to contest the decision of the National Health Service to the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law. A decision of the Ministry of Health may be appealed to a court.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

66. The State Pharmacy Inspection shall control the compliance with the procedures for reimbursement by the undertakings of pharmaceutical activity and shall inform the National Health Service in writing regarding any violations determined.

[1 April 2008; 25 August 2009; 22 September 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

VIII. Reimbursement of Medicinal Products and Medical Devices Included on Lists C and R

[26 March 2024]

67. The National Health Service shall inform the medical treatment institution of the following:

67.1. the reimbursement of medicinal products or medical devices included on List C if the National Health Service has received a letter signed by the head of sabiedrība ar ierobežotu atbildību "Rīgas Austrumu klīniskā universitātes slimnīca" [limited liability company Riga East University Hospital], valsts sabiedrība ar ierobežotu atbildību "Paula Stradiņa klīniskā universitātes slimnīca" [State limited liability company Pauls Stradiņš Clinical University Hospital], valsts sabiedrība ar ierobežotu atbildību "Bērnu klīniskā universitātes slimnīca" [State limited liability company Children's Clinical University Hospital], sabiedrība ar ierobežotu atbildību "Daugavpils reģionālā slimnīca" [limited liability company Daugavpils Regional Hospital], or sabiedrība ar ierobežotu atbildību "Liepājas reģionālā slimnīca" [limited liability company Liepāja Regional Hospital] supplemented by the decision of the council of experts of the relevant field of medical treatment on necessity of using the particular medicinal products or medical devices for a particular patient, and the decision includes information on the diagnosis, the code of the diagnosis according to the ICD, the medicinal product name, the pharmaceutical form, the strength, dose, or the type of the medical device, the justification of using the medicinal products or medical devices, the recommended duration of the treatment course, and the required quantity of medicinal products;

67.2. the reimbursement of medicinal products or medical devices included on List R if the National Health Service has received the decision from a council of medical specialists in the relevant medical field of the limited liability company Riga East University Hospital, the State limited liability company Pauls Stradiņš Clinical University Hospital, or the State limited liability company Children's Clinical University Hospital on the necessity of using the medicinal products or medical devices for a specific patient, and the decision includes information on the diagnosis, the diagnosis code in accordance with the ICD, the name of the medicinal product, the pharmaceutical form, the strength, the dose or the type of medical device, justification for the necessity of using the medicinal products or medical devices that corresponds to the conditions for prescribing medicinal products or medical devices, the recommended duration of treatment course and the required quantity of medicinal products, and the medical treatment institution (in the case of parenteral medicinal products) where the administration of medicinal products will be provided to the patient.

[21 December 2021; 26 March 2024]

67.¹ The National Health Service shall inform the medical treatment institution in writing of the refusal to reimburse medicinal products and medical devices included on List C or R if:

67.¹1. the particular case does not conform to the requirements referred to in Paragraph 67 of this Regulation;

67.¹2. the particular case does not conform to the conditions for prescribing medicinal products or medical devices specified in the decision on the inclusion of medicinal products or medical devices on List C or R.

[21 December 2021]

67.² [Deleted]

67.³ The medical treatment institution is entitled to provide or the medical practitioner is entitled to issue a prescription for reimbursable medicinal products from Lists C and R to the patient after receiving written confirmation from the National Health Service for the reimbursement of medicinal products included on List C or R for the specific patient.

[26 March 2024]

68. The National Health Service shall inform the applicant in writing, indicating the medical treatment institution to which the applicant delivers medicinal products or medical devices in accordance with the entered into contract. The applicant shall reimburse the expenditures for the acquisition of medicinal products or medical devices until the end of the term specified in the decision by the council of the medical treatment institution referred to in Paragraph 67 of this Regulation.

[26 March 2024]

68.¹ The delivery of and payment for the parenteral medicinal products included on List C or R intended for the treatment of diseases referred to in Paragraph 5 of Annex 1 to this Regulation shall be carried out in accordance with the following procedures:

68.¹1. the applicant shall inform the National Health Service in writing of the medicinal product wholesaler which will supply the parenteral medicinal products to medical treatment institutions. The National Health Service shall inform the medical treatment institutions in writing of the medicinal product wholesaler selected by the applicant;

68.¹2. the medical treatment institution shall request medicinal products from the medicinal product wholesaler in accordance with the decision of the National Health Service on the reimbursement of medicinal products included on List C or R for the specific patient;

68.¹3. the medicinal product wholesaler, after receiving the request from the medical treatment institution, shall supply the medicinal products to the respective medical treatment institution in accordance with the specified basic reimbursement price;

68.¹4. the medical treatment institution shall submit to the National Health Service the invoice and the report on the use of medicinal products, indicating in the report the information regarding the amount of medicinal products used for the specific patient;

68.¹5. following the receipt of the invoice and the report, the National Health Service shall perform the settlement with the medical treatment institution;

68.¹6. the medical treatment institution shall settle with the medicinal product wholesaler for the delivered amount of medicinal products.

[26 March 2024]

69. The National Health Service shall record all medical council decisions received in relation to the necessity of using medicinal products and medical devices included on List C or R and shall indicate the following:

69.1. the patients whose medicinal products or medical devices are covered from the funds granted for reimbursement, from the applicant's funds or from both;

69.2. the medical practitioner (the medical treatment institution) who prescribes the relevant medicinal products or medical devices;

69.3. the duration and costs of the treatment course.

[21 December 2021]

70. If a patient has discontinued the utilisation of the relevant medicinal products or medical devices or has received a complete treatment course, the particular medical treatment institution shall inform the National Health Service thereof within 10 days after discontinuing of utilisation of the medicinal products or medical devices.

[21 December 2021]

IX. Supervision of Financial Resources

71. The National Health Service shall administer the funds granted for the reimbursement. In planning the distribution of the financial resources granted, the following conditions shall be taken into account:

71.1. resources for the reimbursement of expenditures for the acquisition of medicinal products and medical devices to individual patients shall be provided for in accordance with Paragraph 99 of this Regulation;

71.2. resources for the reimbursement of expenditures for the acquisition of medicinal products and medical devices included on Lists C and R shall be provided for;

71.3. resources for patients to whom, according to the prescription conditions, the medicinal products may be prescribed only by specialists of the particular medical treatment institution, shall be provided for;

71.4. a 5 % reserve shall be planned, deducting the resources referred to in Sub-paragraphs 71.1, 71.2, 71.3, 71.6, and 71.7 of this Regulation from the total financial resources;

71.5. financial resources for the prescribing of reimbursable medicinal products and medical devices, which is performed by the doctors referred to in Paragraph 84 of this Regulation, shall be planned, deducting the resources referred to in Sub-paragraphs 71.1, 71.2, 71.3, 71.4, and 71.7 of this Regulation from the total financial resources;

71.6. resources shall be provided for persons in imprisonment;

71.7. resources shall be provided for the reimbursement of expenditures for the acquisition of the List M medicinal products.

[25 August 2009; 19 October 2011; 24 July 2012; 21 December 2021]

71.¹ In order to plan the distribution of the allocated financial resources and monitor their use, the National Health Service is entitled to request information on the medicinal products supplied to pharmacies and the quantity thereof. Merchants to whom the State Agency of Medicines has issued the special authorisation (licence) to operate a medicinal product wholesaler shall submit the abovementioned information to the National Health Service upon request thereof.

[16 July 2024]

72. The National Health Service shall obtain information regarding the amount of the necessary financial resources:

72.1. in the case referred to in Sub-paragraph 71.3 of this Regulation - by multiplying the anticipated number of patients (taking into account the management information system data regarding the previous period) by the amount of financial resources provided for one patient in the subsequent calendar year;

72.2. in the case referred to in Sub-paragraph 71.6 of this Regulation - by multiplying the anticipated number of patients laid down by the Prison Administration in diagnoses and groups of diagnoses by the amount of financial resources utilised in the State for one patient in the relevant diagnosis or group of diagnosis.

[19 October 2011 / The new wording of the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

73. The resources referred to in Sub-paragraph 71.5 of this Regulation shall be calculated on the basis of the following indicators:

73.1. the expenses of the previous period for the covering of expenditures for the acquisition of the relevant medicinal products or medical devices (if a time period shorter than 12 months is used for calculations, the obtained data shall be re-calculated in proportion, related to 12 months);

73.2. the calculation of treatment costs and the impact thereof on the funds granted for reimbursement performed by the National Health Service if it is intended to include new medicinal products or medical devices on the list of reimbursable medicinal products or it is intended to make any changes in the list of reimbursable medicinal products.

[25 August 2009; 22 September 2009; 19 October 2011; 16 July 2019]

74. The medicinal products and medical devices referred to in Sub-paragraph 71.5 of this Regulation and the amount of financial resources planned for the reimbursement of expenditures for the acquisition thereof shall form a speciality group of reimbursable medicinal products - medicinal products or medical devices that are prescribed by a medical practitioner of the respective speciality or a family doctor.

75. The National Health Service shall revise the list of the medicinal products and medical devices included in the speciality group of reimbursable medicinal products and the financial resources intended for the relevant group, if a decision is taken on changes in the list of reimbursable medicinal products.

[19 October 2011 / The new wording of the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

76. [21 December 2021]

77. [21 December 2021]

78. The planned amount of finances for the prescription of reimbursable medicinal products and medical devices per outpatient visit in the respective speciality of doctors shall be calculated, using the following formula:

I = P : AA, where

P - the anticipated amount of finances for the speciality group of reimbursable medicinal products;

AA - the anticipated number of outpatient visits in the relevant speciality of doctors.

79. The National Health Service shall calculate the anticipated number of outpatient visits in the relevant speciality of doctors on the basis of the number of outpatient visits registered in the management information system of the National Health Service in the previous period.

[25 August 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

79.¹ When calculating the number of outpatient visits in the speciality of family doctors, the visits to nurses of family doctors or physician assistants falling within the voluntary quality assessment system shall be added to the visits to family doctors in order to receive a prescription of reimbursable medicinal products or medical devices without a visit to a family doctor.

[19 October 2011 / The Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

80. [19 October 2011 / See Paragraph 2 of Amendments]

81. [21 December 2021]

82. The National Health Service has the right to revise the amount of finances specified for a medical treatment institution in a contract for the prescription of reimbursable medicinal products and medical devices in the respective speciality of doctors and to use the planned reserve in the following cases:

82.1. the National Health Service has taken a decision on changes in the list of reimbursable medicinal products (for example, the change in supplementation of the list of reimbursable medicinal products or the prescription conditions);

82.2. the structure of reimbursable medicinal products and medical devices prescribed by doctors of a medical treatment institution and actual costs thereof do not comply with the speciality group (the National Health Service shall change the amount of financial resources for medical practitioners and medical treatment institutions after the assessment of data of not less than six months (on 1 September of the current year) and nine months (on 1 November of the current year).

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

83. The National Health Service shall, once a month, submit a report to the Ministry of Health on the utilisation of the funds granted for reimbursement, indicating also all such cases where the expenditures for the acquisition of medicinal products and medical devices have been covered in accordance with Chapter XII of this Regulation.

[21 October 2014]

X. Duties of Medical Practitioners

84. The reimbursable medicinal products and medical devices, and also medicinal products of List M shall be prescribed using a specific form of prescription in accordance with the laws and regulations on the issue of prescriptions by an attending doctor to whom such rights have been laid down in the contract entered into by and between the medical treatment institution and the National Health Service on provision of health care services or on the amount of funding for prescribing reimbursable medicinal products and medical devices in the relevant speciality of a doctor.

[25 August 2009; 19 October 2011; 24 July 2012 / Amendments to the Paragraph shall come into force on 1 September 2012. See Paragraph 3 of Amendments]

84.¹ If the patient has not previously received, under the reimbursement procedure, the medicinal products included on List A of reimbursable medicinal products intended for a specific diagnosis, or if he or she has received the medicinal products and no medically justified need has been established to use medicinal products with a specific (commercial) name included in the said list, the medical practitioner shall prescribe the common name of the medicinal products intended for this diagnosis on a special prescription form. The medical practitioner shall, in total during a calendar year, prescribe the common name of medicinal products intended for the relevant diagnosis on a special prescription form in at least 70 per cent of cases.

[16 July 2019 / New wording of the Clause shall come into force on 1 April 2020. See Paragraph 2 of amendments]

84.² If the use of medicinal products dispensed in accordance with Paragraph 89 of this Regulation does not produce the desired therapeutic effect, the medical practitioner shall prescribe other medicinal products instead, starting with the lowest price within the common name. The medical practitioner shall indicate in the patient's medical record the justification for changing the medicinal products or for prescribing medicinal products with a specific (commercial) name included on List A of reimbursable medicinal products. The doctor shall notify the State Agency of Medicines on adverse effects observed in conformity with the laws and regulations on supervision of adverse effects caused by the use of medicinal products and medical devices.

[16 July 2019 / New wording of the Clause shall come into force on 1 April 2020. See Paragraph 2 of amendments]

84.³ If in the case referred to in Paragraph 84.¹ of this Regulation the medical practitioner has prescribed medicinal products with a specific (commercial) name in more than 30 per cent of cases during a calendar year, the National Health Service shall, when conducting an inspection, evaluate the justification provided in the medical documentation.

[16 July 2019 / New wording of the Clause shall come into force on 1 April 2020. See Paragraph 2 of amendments]

85. In prescribing the medicinal products and medical devices included on List A, the pharmacy price of which is higher than the reference price, the physician shall inform the patient thereof.

86. In prescribing insulin preparations, the physician shall make an entry in the insulin card of the patient of diabetes mellitus.

86.¹ In prescribing medicinal products for a pregnant woman in the case referred to in Sub-paragraph 9.²2 of this Regulation, the physician shall indicate additionally the diagnosis code "Z33" on the prescription, but in prescribing medicinal products for a woman during the period following the childbirth up to 70 days, the physician shall indicate additionally the diagnosis code "Z39.2" on the prescription.

[24 July 2012; 7 August 2018]

XI. Duties of Pharmacies

87. A pharmacy which is engaged in a contractual relationship with the National Health Service shall dispense to a patient the medicinal products and medical devices the expenditures for the acquisition of which are partly or completely covered from the funds granted for reimbursement.

[26 March 2024]

88. [7 August 2018]

89. If a physician, in writing a prescription for reimbursable medicinal products, has used the common name of a medicinal product, the pharmacy has a duty to dispense the cheapest reimbursable medicinal products, which conform to this name, the prescribed pharmaceutical form and strength, but if there are two or more medicinal products on the list of reimbursable medicinal products with the cheapest basic reimbursement price the pharmacist shall offer the patient to choose any of them. If a physician, in writing a prescription for reimbursable medical devices, has used their common name, the pharmacy has a duty to dispense the cheapest reimbursable medical devices, which conform to this name and type of use, but if there are two or more medical devices on the list of reimbursable medical devices with the cheapest basic reimbursement price the pharmacist shall offer the patient to choose any of them. If a pharmacy has provided the State Agency of Medicines with the information referred to in Paragraph 91 of this Regulation on unavailability of the reference medicinal products or the cheapest reimbursable medical products within the scope of the common name and the State Agency of Medicines has posted information on its website regarding the shortage of the medicinal products, the pharmacist may dispense the next cheapest medicinal product to the patient. If there are two or more medicinal products or medical devices with the lowest basic reimbursement price on the list of reimbursable medicinal products and medical devices, the pharmacy has the duty to store all of the least expensive medicinal products and medical devices in its stock.

[26 May 2015; 7 August 2018; 16 July 2019]

90. If a physician, when prescribing reimbursable medicinal products, has not indicated in the prescription that the prescribed medicinal products may not be substituted, but the medicinal products are not available at the pharmacy and the State Agency of Medicines has published information on its website (in the Medicinal Product Register) that the medicinal products are not available at medicinal product wholesalers, the pharmacist shall inform the patient of substitution options, offering the least expensive corresponding reimbursable medicinal products, taking into account the following provisions:

90.1. the active substances of the medicinal products prescribed and dispensed are identical;

90.2. the form of the dispensed medicinal products is identical to the form of the prescribed medicinal products;

90.3. the single dose of the dispensed medicinal products is appropriate, divisible if the division of tablets is not prohibited in the package leaflet, or can be simply increased to match the single dose of the prescribed medicinal products;

90.4. the total dose of the dispensed medicinal products does not exceed the total dose of the prescribed medicinal products.

[26 March 2024]

91. If the pharmacy had no possibility to purchase medicinal products included on the list of reimbursable medicinal products within 24 hours, the pharmacy shall inform the State Agency of Medicines thereof using the report form on the website of the State Agency of Medicines. The State Agency of Medicines shall contact the relevant marketing authorisation owner or the distributor of parallel imported, parallel distributed or unregistered medicinal products and, if a confirmation has been received that the medicinal product is not available in Latvia, it shall publish information on its website regarding the shortage of medicinal products.

[7 August 2018 / New wording of the Clause shall come into force on 1 January 2019. See Paragraph 2 of amendments]

XI.¹ Reimbursement of Medicinal Products and Medical Devices in Emergency Cases

[27 May 2025 / Chapter shall come into force on 1 July 2025. See Paragraph 149]

91.¹ Each year, the National Health Service shall reserve not more than one million euros from the State budget funds provided for the reimbursement of medicinal products for the reimbursement of expenditures for the acquisition of medicinal products and medical devices for patients in emergency cases for saving lives of patients. The National Health Service shall inform the medical treatment institutions referred to in Paragraph 91.² of this Regulation of the amount of funds available.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

91.² The State limited liability company Children's Clinical University Hospital, the State limited liability company Pauls Stradiņš Clinical University Hospital, and the limited liability company Riga East University Hospital shall establish a joint council delegating therein the permanent members of the council (hereinafter - the council of university hospitals) who, within the scope of the funding available in a calendar year, shall take the decision of the council on the necessity to use medicinal products and medical devices corresponding to international guidelines for a specific patient in emergency cases in order to save the life of the patient. The council of university hospitals shall be managed and the decision of the council shall be prepared by the clinical university hospital which has brought forward the patient to the council or convened a meeting of the council. The council of university hospitals may invite other sectoral specialists for taking the decision.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

91.³ The clinical university hospital referred to in Paragraph 91.² of this Regulation which has brought forward the patient to the council or convened a meeting of the council shall, without delay, inform the National Health Service of the decision of the council of university hospitals and of the amount of financial resources necessary for the therapy of the patient, and also of the discontinuation of the therapy.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

91.⁴ The clinical university hospital referred to in Paragraph 91.² of this Regulation which ensures medical treatment of the patient according to the council of university hospitals shall acquire the medicinal products necessary for the patient from its own funds, taking into account the actual necessity and without exceeding the treatment course of 12 months.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

91.⁵ The National Health Service shall pay for the expenditures for the medicinal products or medical devices actually used for the patient in the case referred to in Paragraph 91.⁴ of this Regulation in accordance with the invoice submitted by the clinical university hospital but not more than for a treatment course of 12 months and without exceeding the total funding.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

91.⁶ The National Health Service shall administer the use of the funds referred to in Paragraph 91.¹ of this Regulation and publish information on the website of the National Health Service on the balance and use of the available funds.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

91.⁷ If, according to the decision of the council of university hospitals, all the funds provided for this objective have been used or marked for ensuring therapy to a specific patient, the council of university hospitals shall not take new decisions until the moment when funds for the next period are reserved in accordance with Paragraph 91.¹ of this Regulation. The balance of the funds from previous years is added to the next calendar year.

[27 May 2025 / Paragraph shall come into force on 1 July 2025. See Paragraph 149]

XII. Reimbursement of Medicinal Products and Medical Devices for Individual Persons

92. The National Health Service is entitled to take a decision if the decision of the council of specialists of the relevant medical treatment sector of the State limited liability company Pauls Stradiņš Clinical University Hospital, the State limited liability company Children's Clinical University Hospital, the limited liability company Riga East University Hospital, the limited liability company Daugavpils Regional Hospital, sabiedrība ar ierobežotu atbildību "Valmieras slimnīca" [the limited liability company Valmiera Hospital], or the limited liability company Liepāja Regional Hospital on the necessity to use medicinal products or medical devices for a specific patient has been received. The decision is taken on the basis of an application of a person. The expenditures for the acquisition of medicinal products shall be reimbursed from the funds granted for reimbursement in the following cases:

92.1. the diagnosis is not included in Annex 1 to this Regulation and the treatment of the relevant disease requires the use of the specific medicinal products (in this case, the acquisition of medical devices is not subject to reimbursement) to support the life functions of the patient;

92.2. the diagnosis is included in Annex 1 to this Regulation, but no medicinal products and medical devices are included on the list of reimbursable medicinal products for medical treatment of the relevant diagnosis;

92.3. the diagnosis is included in Annex 1 to this Regulation, but the medicinal products and medical devices included on the list of reimbursable medicinal products at the relevant diagnosis are not effective (is not applicable to the cases when a disease has progressed as a result of using the medicinal products) or are contraindicated. This condition shall be applicable within the scope of one pharmacotherapeutic group of medicinal products (five characters in the ATC/DDD classification). If the therapy has lines, the condition shall be applicable to medicinal products within the scope of one therapy line.

[27 May 2025]

93. The following information shall be indicated in the council's decision (if a person has several diseases, for the treatment of which reimbursement of medicinal products or medical devices is being requested, one decision of the council may be submitted, if the composition of the council includes experts of all the respective fields and information referred to in this Paragraph regarding each diagnosis has been indicated):

93.1. the given name, surname, personal identity number (except the asylum seeker referred to in Paragraph 3.¹ of this Regulation), address of the patient;

93.2. the diagnosis (the diagnosis code in accordance with the ICD) for the medical treatment of which the reimbursement of medical products or medical devices is being requested;

93.3. the medicinal products previously used for the treatment of the patient (the common name, medicinal product name, dosage, length of usage) and medical devices, including reimbursable medicinal products and medical devices. If medicinal products that are not included on the list of medicinal products authorised in the Republic of Latvia are selected for the further treatment, it shall be indicated whether the patient has been treated using analogical authorised medicinal products;

93.4. the result of the use of the medicinal products and medical devices referred to in Sub-paragraph 93.3 of this Regulation (justifying with the results of examinations). If the medicinal products and medical devices included on the list of reimbursable medicinal products for the treatment of the patient's diagnosis are not effective or are contraindicated (endangering the life functions of the patient) for the specific patient, this must be substantiated (including with examination results);

93.5. the medicinal products (the common name of the medicinal product, medicinal product name, pharmaceutical form, required daily dosage, duration of course) or medical devices (name of the medical device, the required quantity), the reimbursement of expenditures for the acquisition of which is necessary to the patient;

93.6. the justification of the selection of the medicinal products and medical devices referred to in Sub-paragraph 93.5 of this Regulation (in comparison to other medicinal products, medical devices and treatment methods, if available, provided for the treatment of the relevant disease), also the justification of the selection of the particular name of medicinal product or medical device if several medicinal product names or medical devices comply with the common name;

93.7. the compliance of the medicinal products and medical devices with the schemes or international guidelines for the treatment of particular diseases, the place of the medicinal product in the scheme of the treatment of the particular disease;

93.8. the term of validity of the decision;

93.9. or it is possible to support the life functions of the patient in medical treatment of the relevant disease without the use of the particular medicinal products (if the diagnosis is not included in Annex 1 to this Regulation);

93.10. whether the patient compliance has been sufficient to objectively evaluate the effectiveness of the medicinal products and medical devices previously used in the treatment of the patient (if the specific case falls under Sub-paragraph 92.3 of this Regulation).

[21 October 2014; 20 Septembr 2016; 26 March 2024; 27 May 2025]

93.¹ If there are substantiated doubts, the National Health Service has the right to transfer the council's decision referred to in Paragraph 93 of this Regulation for additional evaluation to the doctors' council of the same treatment field in other composition.

[27 January 2009; 25 August 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

94. In the case referred to in Sub-paragraph 92.1 of this Regulation the National Health Service shall take a decision to reimburse expenditures for the acquisition of medicinal products in the amount of 100 %, except the case referred to in Paragraph 100.¹ of this Regulation.

[27 March 2007; 25 August 2009; 19 October 2011; 20 September 2016]

95. In the case referred to in Sub-paragraph 92.2 of this Regulation the National Health Service shall take a decision to reimburse expenditures for the acquisition of medicinal products or medical devices within the amount laid down in Annex 1 to this Regulation, except for the case referred to in Sub-paragraph 100.¹ of this Regulation.

[27 March 2007; 25 August 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

95.¹ In the case referred to in Sub-paragraph 92.3 of this Regulation, the National Health Service shall take the decision on the reimbursement of expenditures for the acquisition of medicinal products within the costs of one line of therapy and/or one pharmacotherapeutic group (five characters in the ATC/DDD classification) of medicinal products included on the list of reimbursable medicinal products for the relevant diagnosis, except for the case referred to in Paragraph 100.¹ of this Regulation.

[26 March 2024]

96. The National Health Service shall perform the calculation of the price of medicinal products or medical device pursuant to the principle of the reference price, if the respective medicinal products or medical devices are included on List A and in case of the particular disease the medicinal products or medical devices comply with the principles of making List A referred to in Paragraph 32 of this Regulation.

[25 August 2009; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

97. [19 October 2011 / See Paragraph 2 of Amendments]

98. Until 10 January and 10 July of the current year the National Health Service shall compile information regarding the applications received within previous six months as regards the reimbursement of expenditures for the acquisition of medicinal products and medical devices in the cases provided in this Chapter (also if reimbursement of medicinal products and medical devices is refused), assess it and, where necessary, lodge proposals to the Ministry of Health on the necessary amendments to Annex 1 to this Regulation.

[19 October 2011 / The new wording of the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

99. Not more than 2.2 % of the funds granted for the reimbursement of expenditures for the acquisition of medicinal products shall be used in the cases of the reimbursement of expenditures for the acquisition of medicinal products and medical devices provided for in this Chapter.

[8 October 2024]

100. The National Health Service shall reimburse the expenditures for the acquisition of medicinal products and medical devices in the cases provided for in this Chapter in the amount of not more than EUR 30 000.00 for one patient over a period of 12 months.

[27 May 2025]

100.¹ If the intended expenditures exceed the expenditures referred to in Paragraph 95.¹ or 100 of this Regulation, the National Health Service shall indicate the reimbursement expenditures for one packaging of medicinal products in the decision to reimburse medicinal products and also the difference between the total expenditures for the course of medicinal products and the expenditures referred to in Paragraph 95.¹ or 100 of this Regulation. The patient shall receive medicinal products, if one of the following conditions exists:

100.¹1. the patient covers the difference between the price of one packaging of the medicinal products and the reimbursement amount indicated in the decision of the National Health Service;

100.¹2. the third party has entered into a contract with the National Health Service regarding financial participation for ensuring the reimbursement for a particular patient;

100.¹3. the applicant has entered into the contract referred to in Sub-paragraph 61.²4 of this Regulation with the National Health Service which provides for financial participation in the provision of reimbursement for medicinal products for a particular patient or a range of patients with the respective diagnosis.

[26 March 2024]

101. The National Health Service shall grant the medicinal products and medical devices to a patient for a treatment course, duration of which does not exceed 12 months. If use of the medicinal products or medical devices must also be continued after this period, the necessary documents shall be submitted to the National Health Service in accordance with Paragraph 92 of this Regulation. If the patient requires changes in the dosage of the medicinal product within 12 months from the moment of taking the decision to reimburse medicinal products, the National Health Service shall amend the decision on the basis of the report by the attending physician of the patient.

[27 May 2025]

102. The National Health Service shall refuse the reimbursement of expenditures for the acquisition of medicinal products if:

102.1. the National Health service has taken a negative decision to include the relevant medicinal products or medical devices on the list of reimbursable medicinal products for medical treatment of the particular diagnosis;

102.2. the annual funds granted for the reimbursement of expenditures for the acquisition of medicinal products and medical devices in individual cases have been utilised;

102.3. the council's decision does not comply with the requirements referred to in Paragraph 93 of this Regulation;

102.4. other medicinal products or medical devices included on the list of reimbursable medicinal products are available to the patient in accordance with the diagnosis referred to in Annex 1 to this Regulation for the treatment of the relevant diagnosis, except for the cases when the medicinal products or medical devices included on the list of reimbursable medicinal products are not effective or are contraindicated;

102.5. the National Health Service has recognised that selection of the medicinal products or medical devices is not justified;

102.6. the medicinal products are classified as non-prescription medicinal products or food supplements in accordance with the laws and regulations regarding the procedures for the classification of medicinal products;

102.7. the treatment of the determined diagnosis or the use of the particular medicinal products or medical devices in medical treatment and their payment procedures are governed by other laws and regulations;

102.8. the State Agency of Medicines has recognised the specific medicinal products or medical devices as not cost-effective for the respective diagnosis.

[19 October 2011; 9 October 2012; 21 October 2014; 21 December 2021; 26 March 2024; 27 May 2025]

103. The National Health Service shall request from the State Agency of Medicines information regarding the sales price of such medicinal products in Latvia, which are not included on the list of reimbursable medicinal products and regarding which the manufacturer of the medicinal products or his or her authorised representative provides information to the State Agency of Medicines in accordance with laws and regulations on the principles of the formation of the price of the medicinal products. The State Agency of Medicines shall send the referred to information within five days after the receipt of the request. The National Health Service shall calculate the costs related to the reimbursement of expenditures for the acquisition of medicinal products in accordance with the Cabinet regulations regarding the principles for the determination of the price of medicinal products.

[16 July 2024]

103.¹ The National Health Service shall request information from the State Agency of Medicines on the availability of centrally registered medicinal products and the pharmacy price thereof. The State Agency of Medicines shall provide the relevant information, additionally indicating the medicinal product wholesalers which will provide the specific medicinal products within the scope of individual reimbursement. In cases where the manufacturer of medicinal products or the authorised representative thereof has failed to submit information on the sales price of medicinal products in Latvia to the State Agency of Medicines and also when determining the price of medical devices, the National Health Service shall survey at least two pharmacies selected by the patient.

[27 May 2025]

104. [27 May 2025]

XIII. Closing Provisions

104.¹ The supervision of conformity with this Regulation shall be performed by the National Health Service and the Health Inspectorate in accordance with their remits.

[19 October 2011 / The new wording of the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

105. Cabinet Regulation No. 418 of 14 June 2005, Procedures for the Reimbursement of Expenses Towards the Purchase of Medicinal Products and Medical Devices for Ambulatory Care (Latvijas Vēstnesis, 2005, No. 99, 210; 2006, No. 50), is repealed.

106. [25 August 2009]

107. The medicinal products included on the list of reimbursable medicinal products, costs of which exceed LVL 3 000 and regarding the reimbursement for the acquisition of which the Health Payment Centre has entered into a contract with the applicant, shall be included on List C without a supplementary application beginning with 1 January 2007.

[25 August 2009]

108. This Regulation shall come into force on 15 November 2006. Chapter IX of this Regulation shall come into force on 1 January 2007.

109. [21 December 2021]

110. [21 December 2021]

111. [21 October 2014]

112. [21 October 2014]

113. [1 April 2013 / See Paragraph 116]

113.¹ [21 October 2014]

114. [21 October 2014]

115. [1 April 2013 / See Paragraph 116]

115.¹ The National Health Service shall make amendments related to changes in the reference price in the decision to include non-reference medicinal products or medical devices on List A only concurrently with other amendments to the decision.

[29 March 2011; 19 October 2011 / Amendments to the Paragraph shall come into force on 1 November 2011. See Paragraph 2 of Amendments]

115.² [21 December 2021]

116. [21 December 2021]

117. [27 December 2011 / See Paragraph 2 of Amendments]

118. [21 December 2021]

119. [21 December 2021]

120. [21 December 2021]

121. [21 December 2021]

122. [1 April 2013 / See Paragraph 116]

123. [21 December 2021]

124. [21 December 2021]

125. The National Health Service shall establish the List M referred to in Paragraph 9.¹ of this Regulation until 15 August 2012 and maintain it on the Internet site thereof.

[24 July 2012 / Paragraph shall be applied from 1 August 2012. See Paragraph 2 of the amendments]

126. The National Health Service shall lay down the basic reimbursement price and pharmacy price for the List M medicinal products referred to in Paragraph 10.¹ of this Regulation on the basis of the manufacturer's price declared in conformity to the laws and regulation on the principles for creation of prices for medicinal products in the State Agency of Medicines on 1 July 2012.

[24 July 2012 / Paragraph shall be applied from 1 August 2012. See Paragraph 2 of the amendments]

127. If reimbursement of medicinal products and medical devices has been started in accordance with the procedures laid down in Chapter XII of this Regulation until 31 December 2012 for a person whose diagnosis has been included in Annex 1 to this Regulation and for the support of the life functions whereof none of the reimbursable medicinal products and medical devices are suitable (the use of the medicinal products and medical devices that are not included on the list of reimbursable medicinal products is necessary), it shall be continued until the end of the term of the validity of the council's decision. The National Health Service is entitled, on the basis of the application of the person to which the council's decision referred to in Paragraph 93 of this Regulation is attached, to take a decision to continue the reimbursement of expenditures for the acquisition of the relevant medicinal products and medical devices in conformity with the conditions referred to in Paragraphs 99, 100, 100.¹ and 101 of this Regulation.

[9 October 2012]

128. Paragraph 45.¹ of this Regulation shall come into force on 1 January 2016.

[21 October 2014]

129. Paragraph 45.¹ of this Regulation shall not be applied, if the budget base for reimbursement procedures in the law on the State budget for the current year has been increased by at least 5 %.

[21 October 2014]

130. If the medical treatment course with the medicinal products referred to in Sub-paragraph 9.¹2 of this Regulation was commenced until 1 November 2014, the expenditures for acquisition of such medicinal products until the end of the medical treatment course, but not longer than until 1 November 2015 shall be reimbursed in accordance with the procedures for covering of the expenditures for acquisition of the medicinal products included on List M.

[21 October 2014]

131. [21 December 2021]

132. [21 December 2021]

133. [21 December 2021]

134. The National Health Service shall take a decision to delete the medicinal products corresponding to the common names of medicinal products included on the list of medicinal products to be administered parenterially (approved in accordance with the laws and regulations regarding the health care and procedures for financing) from the list of reimbursable medicinal products as of 1 January 2019. Upon deleting the medicinal products from the list of reimbursable medicinal products, the National Health Service shall refund to the applicant the remaining part of the annual charge paid. If the medicinal products to be administered parenterially have been included on the list of reimbursable medicinal products both for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation and for the treatment of other diseases, the National Health Service shall take the decision to delete such medicinal products only for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation.

[19 December 2017]

135. For medicinal products and medical devices for which, according to Paragraph 16.³ of this Regulation, the basic reimbursement price has been temporarily reduced by determining a time period in which the reduced reimbursement price is applied, the term for the application of the temporarily reduced price shall be revoked as of 1 September 2018.

[7 August 2018]

136. As regards the medicinal products of one common medicinal product name or medical devices with the same type of use included on List A whose pharmacy price exceeds the lowest pharmacy price of the medicinal products or medical devices of the relevant group by more than 100 % by calculating in accordance with the daily dosage defined in the ATC/DDD classification or, if such has not been determined, in accordance with the therapeutic daily dosage, the applicant shall, by 1 September 2018, and also repeatedly by 1 September 2019, submit the application to the National Health Service on the reduction of the basic reimbursement price until the determined 100 % price spread threshold or by 20 %, taking into account the current pharmacy prices of the reimbursable medicinal products.

[7 August 2018]

137. The doctor referred to in Sub-paragraph 69.3 of this Regulation may write out the prescription for the receipt of medicinal products of the List C to be administered parenterially and intended for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation, and the patient may receive medicinal products on the prescription by 31 December 2018. The receipt of medicinal products of the List C to be administered parenterially and intended for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation shall, in accordance with Paragraph 68.¹ of this Regulation, be commenced from 1 January 2019.

[7 August 2018]

138. The applicant shall, in accordance with this Regulation, submit the application for the inclusion of the medicinal products in the list of reimbursable medicinal products in which the price of medicinal products is justified by calculations for an acquired quality-adjusted life year and the National Health Service shall evaluate such application from 1 July 2019.

[7 August 2018]

139. In order to fulfil the requirements referred to in Paragraph 36.² of this Regulation for medicinal products included on the list of reimbursable medicinal products until 15 July 2019, the applicant shall submit an application to the National Health Service by 1 February 2020 to reduce the basic reimbursement price to the specified 100 % price difference threshold, and the new price shall be approved on 1 April 2020.

[16 July 2019]

140. Applications for the inclusion of new medicinal products and medical devices on the list of reimbursable medicinal products and applications for the revision of reimbursement conditions for medicinal products and medical devices which were submitted prior to the reorganisation of the functions of the National Health Service and the State Agency of Medicines shall be examined without receiving an opinion from the State Agency of Medicines and their therapeutic and economic assessment shall be carried out by the National Health Service.

[16 July 2019]

141. The calendar year referred to in the amendments to Paragraphs 84.¹ and 84.³ (coming into force on 1 April 2020) shall not be applied in 2020. In 2020, the percentage of the common names of medicinal products prescribed on the special prescription form shall be evaluated for the period from 1 April 2020 to 31 December 2020.

[16 July 2019]

142. [26 March 2024]

143. Sub-paragraph 16.1 of Annex 1 to this Regulation shall not be applied from 15 September 2021 to 1 May 2022.

[14 September 2021]

144. Medicinal products for the treatment of rare diseases which in accordance with the laws and regulations prescribe the procedures for the organisation of and payment for health care services were included in the contract with the National Health Service shall be included in List R of reimbursable medicinal products without applying the application examination fee determined in accordance with the price list of the National Health Service and by conducting a price conformity assessment in accordance with the requirements of this Regulation.

[21 December 2021]

145. Upon request of the National Health Service, the applicant shall inform the National Health Service in writing of the medicinal product wholesaler which will supply the parenteral medicinal products for receipt in closed-type pharmacies. The National Health Service shall inform the medical treatment institutions in writing of the medicinal product wholesaler selected by the applicant.

[26 March 2024]

146. In cases where it is stipulated to provide specific parenteral medicinal products in closed-type pharmacies or medical treatment institution pharmacies pursuant to Sub-paragraph 61.²5 of this Regulation, general or open-type pharmacies may dispense the specific parenteral medicinal products available in the pharmacy, but not longer than for a month from the moment when it was stipulated to provide the specific parenteral medicinal products in closed-type pharmacies or medical treatment institution pharmacies.

[26 March 2024]

147. As of 1 April 2024, medicinal products for the treatment of diseases referred to in Sub-paragraph 14.4.1 of Annex 1 to this Regulation (Myasthenia gravis and other myoneural pathologies) shall be reimbursed at a rate of 100 %.

[26 March 2024]

148. Paragraph 100 of this Regulation regarding the reimbursement of expenditures for the acquisition of medicinal products and medical devices not exceeding EUR 30 000.00 per patient over a period of 12 months shall be applicable from 1 October 2024.

[8 October 2024]

149. Chapter XI.¹ of this Regulation, Reimbursement of Medicinal Products and Medical Devices in Emergency Cases, shall come into force on 1 July 2025.

[27 May 2025]

Informative Reference to the European Union Directives

This Regulation includes legal norms arising from Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.

Prime Minister A. Kalvītis

Minister for Health G. Bērziņš

Annex 1
Cabinet Regulation No. 899
31 October 2006

[26 March 2024 / The Annex shall come into force on 1 July 2024. See Paragraph 3 of Amendments]

Diseases for the Treatment of which Expenditures for the Acquisition of Medicinal Products and Medical Devices are Reimbursed

Annex 2
Cabinet Regulation No. 899
31 October 2006

[27 MaY 2025]

Groups of Medical Devices for Inclusion on the List of Reimbursable Medicinal Products, and the Level of Reimbursement of Expenditures for the Acquisition Thereof

Annex 3
Cabinet Regulation No. 899
31 October 2006

Guidelines for Economic Evaluation of Medicinal Products

[25 August 2009; 22 September 2009; 19 October 2011; 10 September 2013; 7 August 2018; 16 July 2019]

1. The Guidelines for Economic Evaluation of Medicinal Products (hereinafter - the Guidelines) are a combination of methods used for pharmaco-economic analysis to support decision-making in listing medicinal products and medical devices on the list of reimbursable medicinal products or deletion thereof from the list.

2. Upon submitting an application for the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, the applicant shall perform pharmaco-economic calculations in accordance with the Guidelines.

3. When examining the application for the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, administration costs of medicinal products or medical devices and the effect on the health care system parameters and costs shall be assessed in accordance with the Guidelines.

4. The following requirements shall be considered in the pharmaco-economic analysis:

4.1. clearly defined research subject;

4.2. performer of the analysis, his or her qualification and relation with the entity contracting analysis is indicated;

4.3. analysis is based on published clinical trial data which attest to the therapeutic equivalence or therapeutic added value of the medicinal product and in which the primary and secondary benefits are defined and research results are shown;

4.4. analysis may be based on unpublished clinical trial data, if they have been submitted for registration of medicinal products;

4.5. conformity with the indications of medicinal products approved in the relevant states is observed. The number of patients included in the analysis shall conform to the number of patients contained in the clinical trial and all additional information applying to the research subject is included in the analysis;

4.6. clinical trial subgroup data is presented additionally in case of significant differences in therapeutic effectiveness or costs;

4.7. the costs and benefits of using the new medicinal product are compared with the costs and benefits of using another alternative therapy (standard treatment or the usual treatment in daily practice in the relevant state):

4.7.1. if the new medicinal product belongs to an existing pharmaco-therapeutic group, the comparator shall be the most commonly used alternative medicinal product in this group;

4.7.2. if the new medicinal product belongs to a new pharmaco-therapeutic group, the comparator shall be the most commonly used alternative drug for the indication;

4.7.3. non-medicinal treatments or no treatment principle may be used as a comparator if they are the most commonly used practice;

4.7.4. doses and duration of comparative treatments shall correspond to those recommended in the summary of product characteristics and treatment guidelines and doses used in the clinical trial. If different doses from those used in the clinical trial are used, such differences shall be justified;

4.7.5. alternative choices shall be justified.

5. The following types of pharmaco-economic analysis shall be distinguished (choice of the specific type shall be justified):

5.1. cost minimisation analysis (CMA). This method shall be applied if the therapeutic value of the new medicinal product is equal to that of the comparator, assuming that if the outcomes of the both treatments are equal, only costs shall be compared;

5.2. cost effectiveness analysis (CEA). This method shall be applied to compare costs and obtained results of two or more alternative treatments each with a common objective. The obtained results shall be measured in physical units. The objective of analysis is to calculate the cost per unit result achieved using the incremental cost-effectiveness ratio;

5.3. cost utility analysis (CUA). The cost utility analysis is a more comprehensive form of cost effectiveness analysis used to calculate the costs for one year-life additionally gained, including the expedience or evaluation of the quality of life. The origin of expedience value shall be explained in the analysis and the method (general or disease-specific) applied to evaluate the quality of life shall be validated.

6. The therapeutic value of the medicinal product shall be determined by the result of use thereof (either for an individual patient or the entire health care system):

6.1. reduced mortality;

6.2. reduced incidence of disease complications;

6.3. reduced incidence of adverse effects caused by the disease;

6.4. incidence of well-controlled therapy symptoms;

6.5. reduced incidence of hospitalisations and recurrence.

7. If the pharmaco-economic analysis has been performed in another state, the results of the study shall be adapted to the conditions of the health care system in Latvia. The following essential criteria shall be considered:

7.1. choice and frequency of adjunctive therapy;

7.2. ratio of patient age and gender;

7.3. evaluation of patient disease severity;

7.4. choice of comparator therapy.

8. The criteria for selecting the applied clinical trials:

8.1. explicitly stated study design;

8.2. randomised, double-blind and controlled trials (non-blinded studies, if the choice is justified);

8.3. clearly defined research subject;

8.4. comparable patient groups at baseline;

8.5. clinically relevant endpoint and study duration based on an "intention to treat" analysis;

8.6. the clinical and statistical significance of the achieved results.

9. The clinical trial analysis may be based on a single clinical trial or meta-analysis (combination of several clinical trials). Meta-analysis increases the precision of the estimates of differences between the new medicinal product and comparative therapy. If calculations are based upon a meta-analysis, selection criteria of trials and the performed statistical tests shall be specified.

10. The results of clinical trials shall be presented as a summary of results for the new medicinal product and comparative therapies. The following data shall be specified for each comparison:

10.1. the number of patients assigned to treatment;

10.2. the number of withdrawals;

10.3. the number of successes and failures presented as the risk of event onset or the ratio between the number of cases per group and the total number of patients in the group (indicating confidence intervals);

10.4. changes in the mean values for the group (indicating confidence intervals).

11. In order to identify the differences in the clinical effectiveness of the new medicinal product and comparative treatments, the absolute risk difference (the difference between the risk of the incidence of events in the studied group and the risk of the incidence of events in the control group) shall be calculated and used for pharmaco-economic analysis. Simultaneously, relative performance measures shall also be calculated (ratio of the risk of the incidence of events in the studied group and the risk of the incidence of events in the control group).

12. The pharmaco-economic analysis shall be performed based on the direct health care costs. Direct health care costs shall include the following:

12.1. costs of medicinal products (including costs of adjunctive therapies and the treatment of adverse effects);

12.2. costs of medical services;

12.3. costs of hospital services;

12.4. costs of diagnostic and laboratory investigation services;

12.5. any other direct health care costs.

13. If additional pharmaco-economic analysis is aimed at the public in general, also other costs shall be included therein (both direct and indirect costs outside the health care system): costs of social services, costs related to the patient transfer and other costs to the patient or his or her family.

14. If the pharmaco-economic analysis is performed based on economic studies performed abroad, all costs shall be adapted to the conditions of the local health care and also sources of data used to estimate costs shall be provided. Costs shall be adjusted according to the following principles:

14.1. pharmaco-economic study costs positions corresponding to the practice in the relevant state shall be established;

14.2. number of costs units (for example, number of consultations, number of bed days);

14.3. changes in the cost per unit of costs;

14.4. all costs shall be specified in euro.

15. If any direct or indirect costs outside the health care system are included, they shall be indicated separately and calculations shall be conducted separately, including the following:

15.1. direct costs within the health care system;

15.2. direct costs outside the health care system;

15.3 indirect costs outside the health care system.

16. Summary data analysis shall include the following comparison parameters of administration of the relevant alternatives:

16.1. treatment costs per acquired result unit for each alternative shall be indicated - costs for a life-year gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year;

16.2. the incremental cost-effectiveness ratio shall be calculated in the cost-effectiveness analysis or cost utility analysis for a life-year additionally gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year to show the difference for one additional result reached with the new medicinal product;

16.3. total costs of both comparable treatments and total benefit for the health care system shall be calculated. Total cost savings in the health care system shall be presented, if relevant.

17. The pharmaco-economic analysis shall include the discounting of costs and benefits that is a standard feature of economic evaluations. Future costs and benefits shall be discounted at an annual rate of 5 %. If another discounting rate is used, justification shall be provided.

18. The sensitivity analysis shall be applied to measure the extent of the effect of factorial (for example, time of the onset of therapeutic result, disease prevalence (patient number in the population), disease incidence (number of new cases per year)) changes upon the results of analysis. The sensitivity analysis shall specify statistical tests performed and the confidence intervals around the main variables.

19. If the pharmaco-economic analysis cannot be performed according to the methods described above, economical modelling techniques can be applied (for example, to model a sufficient analysis period when trial data provide too short time frame, or when the data originate from a study which was carried out in settings of a different system). The economic model shall be presented in a manner that will enable the replication of the analysis, concurrently submitting electronic copy of the spreadsheets or the software used. The indicators of effectiveness and costs used in the model must be substantiated. The economic model shall be based upon scientific evidence.

Minister for Health G. Bērziņš

Annex 4
Cabinet Regulation No. 899
31 October 2006

[10 September 2013; 16 July 2024]

Wholesaler Mark-up Applicable to Basic Reimbursement Price for the Medical Devices Included on the List of Reimbursable Medicinal Products

Annex 5
Cabinet Regulation No. 899
31 October 2006

[10 September 2013; 16 July 2024]

Correction Coefficients and Correction Sums Applicable to Pharmacy Price Calculation for the Medical Devices Included on the List of Reimbursable Medicinal Products

Annex 6
Cabinet Regulation No. 899
31 October 2006

Maximum Permissible Difference in Costs of Medicinal Products for Different Pharmaceutical Forms of the Same General Name

Minister for Health G. Bērziņš

Annex 7
Cabinet Regulation No. 899
31 October 2006

Plan to Introduce the Procedures for Reimbursing Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for Outpatient Medical Treatment

[25 August 2009]

Annex 8
Cabinet Regulation No. 899
31 October 2006

[26 March 2024]

Information on Current Medicinal Product Prices (in Euros) in the Countries Referred to in Paragraph 30 of Cabinet Regulation No. 899 of 31 October 2006, Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for Outpatient Medical Treatment

Translation © 2025 Valsts valodas centrs (State Language Centre)