Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for the Package Leaflet of Medicinal Products

Issued pursuant to Section 5, Clauses 3 and 12
of the Pharmaceutical Law

I. General Provisions

1. This Regulation prescribes the procedures for the labelling of medicinal products and the requirements to be set for the package leaflet of medicinal products (hereinafter - the package leaflet).

2. The Regulation shall not apply to:

2.1. veterinary medicinal products;

2.2. intermediate products intended for further processing carried out by a licensed medicinal product manufacturer;

2.3. medicinal products which are intended for research and development trials and which are not used in relation to clinical trials on medicinal products within the meaning of Regulation (EU) No 536/2014 of the European Parliament and of the Council of of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (hereinafter - Regulation No 536/2014);

2.4. radionuclides (radioactive isotopes) in the form of sealed radiation sources;

2.5. whole blood, plasma or blood cells of human origin, except for industrially prepared plasma.

[12 March 2024]

2.¹ Labelling of the packaging of unauthorised investigational medicinal products and unauthorised auxiliary medicinal products shall be arranged in accordance with the requirements laid down in Chapter X of and Annex VI to Regulation No 536/2014.

[12 March 2024]

2.² Labelling of the packaging of authorised investigational medicinal products and authorised auxiliary medicinal products shall be arranged in accordance with the requirements laid down in Chapter X of and Annex VI to Regulation No 536/2014 or in accordance with this Regulation.

[12 March 2024]

3. Information in the labelling of the immediate packaging (which has direct contact with the medicinal product) and the outer packaging (into which the immediate packaging is placed) of medicinal products, as well as information in the package leaflet shall be specified in accordance with the requirements laid down in the Official Language Law.

4. The package leaflet shall be included (placed or attached) in all packaging of medicinal products, unless all the information referred to in Sub-paragraph 7.3, Paragraphs 14, 14.¹, and 15 of this Regulation is already clearly laid out on the outer or on the immediate packaging.

[2 February 2016]

5. If for medicinal products which are brought into Latvia information on the labelling and in the package leaflet is not indicated in the official language, then, upon distributing the medicinal products, an adhesive label shall be attached to the packaging of the medicinal products with translation of the information provided on the labelling in the official language, and the package leaflet in the official language shall be placed in the outer packaging or attached to the outer or immediate packaging of the medicinal products (shall not apply to medicinal products which are distributed in retail in order to export them to the third countries or to supply to another Member State of the European Economic Area). If the outer packaging is closed in such a manner that it cannot be opened without damaging the packaging (for example, glued), the package leaflet in the official language shall be attached to the outside of the packaging. Attaching of the abovementioned adhesive label and package leaflet to the packaging or placing in the outer packaging shall be deemed re-packaging of medicinal products which is carried out by a person who, in accordance with the laws and regulations regarding the procedures for licensing pharmaceutical activity, has a special authorisation (licence) for the manufacturing of medicinal products issued by the State Agency of Medicines.

[2 February 2016]

6. The requirements referred to in Paragraph 5 of this Regulation shall not apply to:

6.1. unauthorised medicinal products which are provided for individual patients and which, in accordance with the laws and regulations regarding the procedures for distribution and quality control of medicinal products, have been brought in on the basis of an authorisation issued by the State Agency of Medicines for distribution of unauthorised medicinal products to medicinal products granted individually, and to which, upon distributing them in a pharmacy, at least the following information in the official language is appended:

6.1.1. the name of the medicinal product;

6.1.2. the name and quantity of the active substance, and excipients;

6.1.3. the pharmaceutical form and content;

6.1.4. instructions for use and route of administration;

6.1.5. special warnings regarding storing of medicinal products out of the reach and sight of children and other special warnings (if indicated);

6.1.6. the expiry date;

6.1.7. storage conditions (if indicated);

6.1.8. the batch number;

6.1.9. special precautionary measures upon destroying non-utilised medicinal products or utilised materials which have come into contact with such medicinal products (if indicated);

6.1.10. the name and address of the marketing authorisation holder, name and address of the manufacturer of medicinal products;

6.1.11. possible adverse reactions (if indicated);

6.2. the medicinal products which are supplied for the use to a medical treatment institution, social care institution, practising veterinarian, and veterinary medical practice institution in packagings which are intended for another country (the information on the labelling and package leaflet is only in a foreign language) if at least one package leaflet of the relevant medicinal product in the official language and translation of the text of the labelling has been attached to the consignment of the particular medicinal product. The supplier of the medicinal product shall ensure the necessary number of translations of the labelling and package leaflets in the official language according to the request of the medical treatment institution, social care institution, practising veterinarian, and veterinary medical practice institution;

6.3. the medicinal products which are in packagings intended for another European Union or European Economic Area Member State (the information on the labelling and package leaflet is only in a foreign language) if a package leaflet of the relevant medicinal product in the official language and translation of the text of the labelling has been attached to each consignment of the particular medicinal product in conformity with the supplied amount of the medicinal product and on which the marketing authorisation owner has provided the notification referred to in Paragraph 6.¹ of this Regulation in the following case:

6.3.1. the medicinal products included in the Register of Medicinal Products of the Republic of Latvia which are included in the list of reimbursable medicinal products (Lists A, B, and C) specified in the laws and regulations regarding the procedures for the reimbursement of expenditures for the acquisition of medicinal products and medical devices intended for the outpatient medical treatment (hereinafter - the list of reimbursable medicinal products) if the following conditions are in effect at the same time:

6.3.1.1. the particular medicinal products are authorised in accordance with national, mutual recognition, or decentralised procedure and their authorisation documentation is identical with the documentation approved in Latvia;

6.3.1.2. other medicinal products which are included in the list of reimbursable medicinal products with the same active substance, strength, and pharmaceutical form and which are not available in Latvia;

6.3.2. the medicinal products authorised in accordance with the centralised authorisation procedure of medicinal products if the medicinal products with the same active substance, strength, and pharmaceutical form included in the Register of Medicinal Products of Latvia are not available in Latvia;

6.3.3. the medicinal products which are the only medicinal products in the Register of Medicinal Products of Latvia with the relevant active substance, strength, and pharmaceutical form and the registration documentation thereof is identical to the documentation approved in Latvia;

6.4. the medicinal products for which exemption of the State Agency of Medicines has been received in accordance with Sub-paragraph 7.6 of this Regulation.

[2 February 2016; 21 December 2021; 12 March 2024]

6.¹ In the case referred to in Sub-paragraphs 6.2 and 6.3 of this Regulation, the marketing authorisation owner shall submit a notification to the State Agency of Medicines on the medicinal products intended for the distribution before commencement of the distribution of such medicinal products in the territory of the Republic of Latvia. The following shall be indicated in the notification:

6.¹1. the name of the medicinal product;

6.¹2. strength, size of the packaging, and quantity;

6.¹3. the batch number and expiry date;

6.¹4. the country for the market of which the medicinal products are intended;

6.¹5. additional information for the analysis of the availability of the medicinal products - duration of the distribution of medicinal products and the information when the labelling of the packaging and package leaflet in the official language will be ensured, for example, by repackaging the medicinal products.

6.¹ 6. information on availability problems in respect of the medicinal products referred to in Sub-paragraph 6.3.3 of this Regulation as they exist at the moment of submitting the notification.

[21 December 2021; 12 March 2024]

6.² Sub-paragraph 6.3 of this Regulation is applied not longer than three months after receipt of the notification referred to in Paragraph 6.¹ of this Regulation at the State Agency of Medicines and shall apply to the medicinal products on wholesale trade.

[21 December 2021]

6.³ The marketing authorisation owner shall be responsible for ensuring that the package leaflet in the official language and translation of the text of the labelling are attached in the relevant amount for the medicinal products of each particular consignment of medicinal products which are referred to in Sub-paragraphs 6.2 and 6.3 of this Regulation by a manufacturer of the medicinal products or wholesaler of medicinal products. When handing out the relevant medicinal products to a patient at a pharmacy, a pharmacist, pharmacist's assistant, or medical practitioner who is referred to in Section 42 of the Pharmaceutical Law shall issue the translation of the labelling and package leaflet of the relevant medicinal product in the official language to the patient and shall direct attention to the fact that the medicinal product is not in the packaging intended for the market of Latvia, and also shall explain correct use of the medicinal product to the patient.

[21 December 2021]

6.⁴ Sub-paragraphs 6.2 and 6.3 of this Regulation are not applied to parallelly imported and parallelly distributed medicinal products.

[21 December 2021]

6.⁵ The State Agency of Medicines shall verify the conformity of the submitted information with the requirements referred to in Paragraph 6.¹ of this Regulation and, in case of non-conformity, shall inform the marketing authorisation owner thereof.

[12 March 2024]

6.⁶ The State Agency of Medicines shall, within three working days after receipt of the information referred to in Paragraph 6.¹ of this Regulation, ensure public availability on its website of at least the following data: the name and strength of medicinal products, the size and quantity of the packaging, the batch number and expiry date, the country for the market of which the medicinal products are intended.

[12 March 2024]

6.⁷ The marketing authorisation owner is entitled to commence the distribution of the medicinal products referred to in Sub-paragraph 6.3 of this Regulation only after publishing the relevant information on the website of the State Agency of Medicines.

[12 March 2024]

7. Labelling and the package leaflet shall meet the following requirements:

7.1. information in the labelling and package leaflet of the medicinal products subject to marketing authorisation shall be provided in accordance with the documentation submitted for the marketing authorisation of the medicinal products and with the requirements laid down in this Regulation. Differences in the labelling and package leaflet of parallelly imported medicinal products shall be permitted in conformity with the requirements laid down in Sub-paragraph 7.11 of this Regulation. Information on the labelling and in package leaflet of medicinal products, in addition to the official language, may be indicated in another foreign language which is different from the foreign language used in the labelling and package leaflet of the medicinal products authorised in Latvia;

7.2. the labelling data referred to in Paragraphs 10 and 11, and in Sub-paragraph 7.3 of this Regulation shall be easily legible, clearly comprehensible and indelible;

7.3. symbols (designations) or pictograms (information signs in the form of a stylised picture) shall be permitted on the outer packaging and in the package leaflet, in order to make clearer the information referred to in Paragraph 10 or Paragraphs 14 and 15 of this Regulation and any other information related to the summary of product characteristics, which is useful for a patient, nevertheless excluding any advertising elements;

7.4. the information referred to in Paragraphs 10, 14, and 15, and Sub-paragraph 7.3 of this Regulation on the labelling, also on the adhesive label, may be in several foreign languages, in addition to the official language, observing the condition that the data provided are the same in all the languages. The data referred to in Paragraph 10 of this Regulation in the labelling of medicinal products intended for the treatment of specific rare diseases (medicinal products, to which such status has been allocated in accordance with the provisions and conditions of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products), upon a substantiated request, may be provided in only one of the official languages of the European Union;

7.5. the package leaflet shall be written and arranged in a clear and comprehensible way. Where necessary, a user may turn for assistance to a health care professional. The package leaflet shall be clearly legible. Such leaflet may be printed in several languages, observing the condition that the information provided is the same in all the languages;

7.6. the State Agency of Medicines is entitled to determine specific measures and to release the marketing authorisation owner and the medicinal product wholesaler from the duty of indicating specific data on the labelling and package leaflet of authorised medicinal products which are referred to on the labelling of marketing authorisation documentation or labelling approved during the authorisation issue process and package leaflet of medicinal products, and also to completely or partially release from the duty of ensuring the labelling and package leaflet of medicinal products in the official language if it is not intended to supply the medicinal products directly to the patient or there are serious problems as regards access to medicinal products. The abovementioned authorisation shall not be necessary for the medicinal products referred to in Sub-paragraphs 6.1, 6.2, and 6.3 of this Regulation;

7.7. the special conditions referred to in Sub-paragraph 15.1 of this Regulation for the users of several categories of medicinal products (patients with specific pathologies) may be specified in the final part of a package leaflet, which part is intended exclusively for medical practitioners. Prior to handing the package leaflet to a patient, a medical practitioner or pharmacist shall remove the final part of the package leaflet;

7.8. the package leaflet shall reflect the results acquired from the consultations with the target groups of patients (users of medicinal products) in order to ensure that the package leaflet is clearly legible, precise and easy to use;

7.9. the accompanying information (for example, an adhesive label, a package leaflet attached to the packaging of the medicinal product) shall not cover the name of the medicinal product, the expiry date, the manufacturing batch number of the medicinal product indicated on the packaging, and also the safety features of medicinal products specified in this Regulation. Addition of information (including placement of the package leaflet in the outer packaging of a medicinal product or attachment thereof to the packaging) may not affect the quality of the medicinal product;

7.10. it is prohibited to print the package leaflet on the inside of the outer packaging of medicinal products;

7.11. if the labelling on the packaging of the parallelly imported medicinal products contains therapeutic indications which are approved by another Member State but are not approved in respect of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia, such information shall be covered with an adhesive label. The labelling and the package leaflet of parallelly imported medicinal products as to their content shall conform to the labelling and the package leaflet of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia in respect of which the parallel import has been performed (hereinafter - the reference medicinal products), allowing for the following differences in the labelling and package leaflet:

7.11.1. in the name of medicinal products referred to in Sub-paragraphs 10.1 and 14.1.1 of this Regulation - if the name of the reference medicinal products differs from the name of the parallelly imported medicinal products in the country, from which the medicinal products are imported;

7.11.2. in specifying the information set out in Sub-paragraphs 10.4 and 14.6.4 of this Regulation - if the parallelly imported medicinal products contain other excipients or colouring matters with a colour code which differs from that of the reference medicinal products and if that affects the degradation period of the medicinal products;

7.11.3. in specifying the information set out in Sub-paragraph 14.6.7 of this Regulation - if the name and address of the manufacturer of the parallelly imported medicinal products differs from that specified in the package leaflet of the reference medicinal products.

[9 April 2013; 2 February 2016; 27 September 2016; 15 January 2019; 21 December 2021]

7.¹ The following information shall be indicated on the adhesive label on the outer packaging or, if none, on the immediate packaging of parallelly imported medicinal products:

7.¹ 1. "Paralēli importētas zāles" [Parallelly imported medicinal products];

7.¹ 2. the number of the authorisation for distribution of parallelly imported medicinal products assigned by the State Agency of Medicines;

7.¹ 3. the name and address of the owner of the authorisation for distribution of parallelly imported medicinal products;

7.¹ 4. if medicinal products have been re-packaged - the batch number of re-packaging, and also the name and address of the manufacturer (re-packager) of the medicinal products if the owner of the authorisation for distribution of parallelly imported medicinal products is not the re-packager of the medicinal products;

7.¹ 5. the differences from the medicinal products included in the Register of Medicinal Products of the Republic of Latvia in relation to which parallel import has been performed, if such exist.

[2 February 2016; 21 December 2021]

8. Free samples of medicinal products in addition to the requirements laid down in this Regulation shall be labelled with an inscription in the official language "Zāļu bezmaksas paraugs - nav paredzēts pārdošanai" [Free medical sample - not for sale] or with another notice conveying the same meaning. The marketing authorisation owner or his or her authorised person shall provide the relevant labelling.

[21 December 2021]

9. The requirements laid down in this Regulation apply also to medicinal products which, in accordance with Council Regulation (EEC) No 918/83 of 28 March 1983 setting up a Community system of reliefs from customs duty, are imported by State institutions or public benefit organisations from the third countries, as well as to medicinal products which in accordance with the procedures prescribed by laws and regulations have been purchased in the European Union Member States or imported from the third countries for funds of foreign financial assistance in accordance with an agreement entered into by the government of the Republic of Latvia, an international agreement or international project registered in the Ministry of Finance, and have been supplied to the assistance beneficiary in Latvia. The recipient of such medicinal products shall provide the additional notice on the labelling "Bez maksas" [Free of charge]. Such notice indicates that the medicinal product may not be distributed in return for payment.

9.¹ A medical treatment institution has the right to perform additional labelling of the packaging of the medicinal products, indicating their belonging to a specific medical treatment institution.

[27 September 2016]

9.² The requirement referred to in Paragraphs 12 and 16 of this Regulation need not be applied to the medicinal products which are referred to in Sub-paragraph 6.1 of this Regulation and to the medicinal products which are distributed in wholesale in order to export them to the third countries or to supply to another Member State of the European Economic Area.

[2 February 2016]

II. Information in the Labelling

10. Labelling on the outer packaging or, if there is no outer packaging, on the immediate packaging shall specify:

10.1. the name of the medicinal product followed by the strength of the product (the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form) and the pharmaceutical form shall be specified, as well as, if necessary, a statement whether the medicinal product is intended for infants, children or adults. If the medicinal product contains not more than three active substances, the international non-proprietary name (INN) shall also be specified, or, if such does not exist, the common name. The medicinal products may have:

10.1.1. the invented name which may not be confused with the common name (the international non-proprietary name (INN) recommended by the World Health Organisation or, if such has not been recommended, the usual common name);

10.1.2. the common or scientific name supplemented by the trademark or the name of the marketing authorisation owner;

10.2. a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;

10.3. the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;

10.4. a list of those excipients known to have a recognised effect and included in the Annex of this Regulation. All excipients shall be specified for injectable medicinal products and medicinal products intended for topical use (for example, on skin, mucous membrane) or for ophthalmologic use;

10.5. the method of administration and, if necessary, the route of administration. A space shall be provided for the prescribed dose to be indicated or for an adhesive label of the pharmacy;

10.6. a special warning that the medicinal product must be stored out of the reach and sight of children;

10.7. other special warnings (if necessary);

10.8. the expiry date, specifying the month and year;

10.9. special storage conditions (if necessary);

10.10. special precautionary measures to be observed in the disposing of the unused medicinal products or waste resulting therefrom (if necessary), as well as an indication that the unused medicinal products shall be delivered to the pharmacy (if special circumstances are necessary for the disposal of the medicinal products);

10.11. the name and address of the marketing authorisation owner and the name of the representative of the marketing authorisation owner if such has been appointed;

10.12. the marketing authorisation number in the Register of Medicinal Products of the Republic of Latvia or an appropriate authorisation number of the European Medicines Agency if the medicinal product has been authorised under the centralised authorisation procedure in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter - Regulation (EC) No 726/2004);

10.13. the manufacturing batch number of the medicinal product. If the medicinal products have been re-packaged or re-wrapped - also the batch number of the re-packaging or re-wrapping;

10.14. for non-prescription medicinal products - instructions regarding the use of the medicinal product;

10.15. the name and address of the manufacturer (re-packager or re-wrapper) of the medicinal products if the medicinal products have been re-packaged or re-wrapped;

10.16. the following safety features of medicinal products which conform to Articles 4, 5, 6, 7, 8, and 9 of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (hereinafter - Delegated Regulation No 2016/161) and which allow a wholesaler of medicinal products, pharmacy, and medicinal treatment institution to verify the authenticity of the medicinal products and to identify certain packagings of medicinal products, and also to verify whether the external packaging of medicinal products is intact:

10.16.1. the unique identifier referred to in Article 3(2)(a) of Delegated Regulation No 2016/161 (hereinafter - the unique identifier);

10.16.2. the anti-tampering device referred to in Article 3(2)(b) of Delegated Regulation No 2016/161 (hereinafter - the anti-tampering device).

[9 April 2013; 2 February 2016; 15 January 2019; 21 December 2021]

11. The information referred to in Paragraph 10 of this Regulation need not be specified on the immediate packaging in the following cases:

11.1. the immediate packaging, for example, blister packs, is placed in the outer packaging which bears the information specified in Sub-paragraph 7.3 and Paragraph 10 of this Regulation, but the immediate packaging bears at least the following information:

11.1.1. the name of the medicinal product in conformity with Sub-paragraph 10.1 of this Regulation;

11.1.2. the name of the marketing authorisation owner;

11.1.3. the expiry date;

11.1.4. the manufacturing batch number of the medicinal product;

11.2. on small immediate packaging units, where it is impossible to specify the information referred to in Sub-paragraph 7.3 and Paragraph 10 of this Regulation, except for the following information:

11.2.1. the name of the medicinal product in conformity with Sub-paragraph 10.1 of this Regulation and, if necessary, the route of administration of the medicinal product;

11.2.2. the method of administration;

11.2.3. the expiry date;

11.2.4. the manufacturing batch number of the medicinal product;

11.2.5. the contents by weight, by volume or by unit.

[21 December 2021]

12. The name and strength of the medicinal products referred to in Sub-paragraph 10.1 of this Regulation on the outer packaging or, if such does not exist, on the immediate packaging shall be specified also in Braille format. If a marketing authorisation has been issued only for a single strength of the medicinal product, only the invented name shall be specified in Braille format. The referred-to condition does not apply to medicinal products the administration of which is provided by a medical practitioner in a medical treatment institution, for example, to vaccines.

12.¹ The safety features of medicinal products referred to in Sub-paragraph 10.6 of this Regulation shall apply to the following medicinal products (except for the radiopharmaceuticals):

12.¹ 1. non-prescription medicinal products or categories of medicinal products which are included in Annex II to Delegated Regulation No 2016/161;

12.¹ 2. prescription medicinal products, except for the prescription medicinal products or categories of medicinal products referred to in Annex I to Delegated Regulation No 2016/161.

[15 January 2019 / Paragraph shall be applied from 9 February 2019 in conformity with the transitional measures specified in Articles 48 and 50 of Delegated Regulation No 2016/161. See Paragraph 40]

12.² The safety features referred to in Sub-paragraph 10.16 of this Regulation need not be indicated:

12.² 1. on authorised medicinal products if it is known during their production that the entire batch of the medicinal products is intended for clinical trials on medicinal products and they are intended to be used as:

12.² 1.1. authorised investigational medicinal products;

12.² 1.2. authorised auxiliary medicinal products;

12.² 2. on unauthorised medicinal products, except for the medicinal products which are authorised in a Member State of the European Economic Area and for which an authorisation for the distribution of medicinal products authorised in a Member State of the European Economic Area but unauthorised in the Republic of Latvia referred to in the laws or regulations regarding distribution of medicinal products has been issued;

12.² 3. on medicinal products which are produced in the European Union and intended for exportation to third countries.

[15 January 2019; 12 March 2024]

12.³ The manufacturer of medicinal products is entitled to apply the anti-tampering device of medicinal products also to non-prescription medicinal products or categories of medicinal products other than those referred to in Annex II to Delegated Regulation No 2016/161 and to those prescription medicinal products or categories of medicinal products which are included in Annex I to Delegated Regulation No 2016/161.

[15 January 2019 / Paragraph shall be applied from 9 February 2019 in conformity with the transitional measures specified in Articles 48 and 50 of Delegated Regulation No 2016/161. See Paragraph 40]

III. Information in the Package Leaflet

13. The marketing authorisation owner shall ensure that information is indicated in the package leaflet according to the summary of product characteristics.

[21 December 2021]

14. The package leaflet shall specify in the following order:

14.1. information for the identification of the medicinal product:

14.1.1. the name of the medicinal product followed by the strength of the medicinal product and the pharmaceutical form (if necessary) shall be specified, indicating whether the medicinal product is intended for infants, children or adults. The common name shall be specified if the medicinal product contains only one active substance and if its name is the invented name;

14.1.2. the pharmaco-therapeutic group or type of activity (in a manner comprehensible for the patient);

14.2. the therapeutic indications;

14.3. information, which is necessary to be known before taking the medicinal product:

14.3.1. contra-indications;

14.3.2. precautionary measures to be observed in the use of the medicinal product;

14.3.3. the interaction with other medicinal products and other forms of interaction (for example, alcohol, tobacco, food) which may affect the effects of the medicinal product;

14.3.4. special warnings;

14.4. the necessary and useful instructions for the correct use of the medicinal product, in particular the following:

14.4.1. the dosage;

14.4.2. the method of administration and, if necessary, route of administration;

14.4.3. the frequency of use, specifying, if necessary, the time when the medicinal product may or should be used;

14.4.4. if necessary, taking into account the nature of the medicinal product, the following shall be specified:

14.4.4.1. the duration of treatment, where limitations are specified;

14.4.4.2. the action to be taken in the case of an overdose of the medicinal product (for example, symptoms, emergency measures);

14.4.4.3. the possible course of action when one or more doses have not been taken;

14.4.4.4. indications regarding the consequences caused by the suspension of the use of the medicinal product (if necessary);

14.4.4.5. special recommendations to consult a doctor or pharmacist to clarify any uncertainties regarding the use of the medicinal product;

14.5. the adverse reactions which may occur when using the medicinal product in conformity with the package leaflet, and, where appropriate, the action to be taken in such situation;

14.6. a reference to the expiry date indicated in the labelling, specifying the following information:

14.6.1. a warning not to use the medicinal product after the expiry date;

14.6.2. regarding special precautionary measures during the storage of the medicinal product (if necessary);

14.6.3. regarding some visible signs of deterioration of the medicinal product (if necessary);

14.6.4. the full qualitative composition (specifying active substances and excipients) and the quantitative composition of the active substances using the common names - for each presentation of the medicinal product;

14.6.5. the pharmaceutical form and content in weight, volume or units of dosage - for each presentation of the medicinal product;

14.6.6. the name and address of the marketing authorisation owner and the names of the representatives of the marketing authorisation owner in the Member States (if such representatives exist);

14.6.7. the name and address of the manufacturer of the medicinal product;

14.7. the name of the medicinal product authorised in each Member State, if the medicinal product in accordance with the provisions for the authorisation of medicinal products has been authorised in the procedure of mutual recognition of the medicinal product authorisation and is permitted with different names in the corresponding Member States;

14.8. the date on which the package leaflet was last revised.

[9 April 2013; 21 December 2021]

14.¹ In addition to the information referred to in Paragraph 14 of this Regulation, the following information shall be indicated in the package leaflet:

14.¹ 1. for medicinal products which require additional monitoring and which are included in the list referred to in Article 23 of Regulation (EC) No 726/2004, an indication "Šīs zāles tiek papildu uzraudzītas" [Medicinal products under additional monitoring] shall be added. The approved black symbol and standardised explanatory text shall be inserted before the indication according to Article 23 of Regulation (EC) No 726/2004 and Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (hereinafter - Commission Implementing Regulation (EU) No 198/2013);

14.¹ 2. information that unequivocally urges the patients to notify their physician, dentist, physician's assistant, nurse, pharmacist or, by using directly the spontaneous reporting system, the State Agency of Medicines of any potential adverse reactions, and also indicate the potential types of reporting in accordance with the laws and regulations regarding the procedures for pharmacovigilance.

[9 April 2013]

15. When providing the information referred to in Sub-paragraph 14.3 of this Regulation, the following shall be specified:

15.1. the special conditions for certain categories of users of the medicinal products (children, pregnant or breastfeeding women, the elderly, persons with specific pathologies);

15.2. the potential effects on the ability to drive vehicles or to operate machinery (if necessary);

15.3. those excipients, the knowledge of which is important for the safe and effective use of the medicinal product and which are included in the Annex of this Regulation.

16. The marketing authorisation owner shall ensure that, upon request of those organisations that represent blind and visually impaired persons, the information provided in the package leaflet is available in a form appropriate for the blind and visually impaired persons.

[21 December 2021]

IV. Labelling and Package Leaflet of Homeopathic Medicinal Products Registered According to the Simplified Registration Procedure, Traditional Herbal Medicinal Products and Radiopharmaceuticals and Their Starting Materials

17. If homeopathic medicinal products are registered by a simplified registration procedure, the labelling and, if necessary, the package leaflet thereof, in addition to a clearly visible inscription "Homeopātiskas zāles" [Homeopathic medicinal products], shall include the following information:

17.1. the scientific name of the homeopathic stock or stocks, using the symbols (designations) of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeia currently used officially in the Member States, followed by the degree of dilution. If a homeopathic medicinal product contains two or more homeopathic stocks, the scientific names of the homeopathic stocks in the labelling may be supplemented by the invented name;

17.2. the name and address of the marketing authorisation owner and, if necessary, of the manufacturer;

17.3. the method of use and, if necessary, the route of administration of the medicinal product;

17.4. the expiry date, specifying the month and year;

17.5. the pharmaceutical form;

17.6. the size of the sales packaging;

17.7. special storage conditions (if necessary);

17.8. special warnings (if necessary);

17.9. the manufacturing batch number of the medicinal product;

17.10. the marketing authorisation number in the Register of Medicinal Products of the Republic of Latvia;

17.11. an indication - "Homeopātiskās zāles bez apstiprinātām terapeitiskām indikācijām" [homeopathic medicinal product without approved therapeutic indications];

17.12. a recommendation to the user to consult a doctor if the symptoms persist during the use of the medicinal product.

[21 December 2021]

18. Packaging for the transportation and containers of radiopharmaceuticals (medicinal products which, when ready for use, contain one or more radionuclides (radioactive isotopes) intended for medical purposes) shall be labelled in accordance with the requirements prescribed by the laws and regulations regarding protection against ionising radiation when transporting radioactive materials. In addition, the labelling of such preparations shall conform to the requirements laid down in Paragraphs 10 and 19 of this Regulation.

19. In labelling radiopharmaceuticals, the following additional conditions shall be observed:

19.1. the labelling of the immediate packaging (vial) shall include:

19.1.1. the name or code of the medicinal product, including the name or the chemical symbol of the radionuclide;

19.1.2. the batch identification data and expiry date;

19.1.3. the radiation symbol;

19.1.4. the name and address of the manufacturer;

19.1.5. the radioactivity referred to in Sub-paragraph 19.2 of this Regulation in a dose or vial;

19.2. the labelling of the outer packaging shall provide an explanation regarding the meaning of the codes specified on the immediate packaging (vial) and, if necessary, indicate the radioactivity per dose or vial at a certain time and date, as well as the number of capsules or for liquids - millilitres.

20. A package leaflet containing the information in accordance with Paragraphs 14 and 15 of this Regulation shall be enclosed in the packaging of radiopharmaceuticals, radionuclide generators (any system used in radiopharmaceuticals incorporating a fixed parent radionuclide from which a daughter radionuclide is produced by elution or by any other method), kits (any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration) or any other radionuclides manufactured for radiolabelling of some other substance before its use, and in addition all precautionary measures shall be specified in such leaflets which are to be observed by a user and patient in preparing and using the relevant preparations, as well as the special precautionary measures to be observed in disposing of the packaging and its unused content.

21. The labelling and the package leaflet of traditional herbal medicinal products (herbal medicinal products, which conform to the criteria of traditional medicinal products prescribed by laws and regulations regarding the provisions for the registration of medicinal products and which have been registered according to the simplified registration procedure) shall, in addition to the requirements laid down in Paragraphs 10, 14 and 15 of this Regulation, contain the following information:

21.1. a statement that the specific product is a traditional herbal medicinal product with specific indications exclusively based upon long-standing use;

21.2. a statement that the user should consult a doctor or a qualified health care specialist if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur;

21.3. a statement regarding the traditional use of the herbal medicinal product.

V. Labelling of Medicinal Products Prepared in Pharmacies

22. If medicinal products are prepared in a pharmacy in accordance with a prescription issued by a medical practitioner for a specific patient or a request of a medical treatment institution (formula magistralis) or such medicinal products are prepared in conformity with pharmacopoeia monographs and they are intended for distribution to patients served by the relevant pharmacy (formula officinalis), the labelling thereof shall contain the following information:

22.1. the name, address and telephone number of the pharmacy;

22.2. the given name and surname of the patient (for children under 14 years of age also the age shall be specified) or the name of the medical treatment institution and department;

22.3. the composition of the medicinal product;

22.4. the conditions for use specified in the prescription of the medicinal product (dose, method of use, route of administration, frequency of use);

22.5. the date of preparation and issuance of the medicinal product;

22.6. the expiry date of the medicinal product (date, month, year);

22.7. the given name, surname and signature of the issuer of the medicinal product;

22.8. special warnings referred to in Paragraph 23 of this Regulation (if necessary);

22.9. an indication - "Glabāt bērniem nepieejamā un neredzamā vietā" [Keep out of the reach and sight of children];

22.10. special storage conditions;

22.11. the number of the prescription or the number of the request of the medical treatment institution;

22.12. the retail selling price (does not apply to medicinal products prepared upon the request of medical treatment institutions).

23. The labelling of medicinal products prepared by pharmacies shall contain the following special warnings:

23.1. "Pirms lietošanas saskalot" [Shake before use] (for mixtures and suspensions) - green letters on a white background;

23.2. "Sargāt no gaismas. Uzglabāt temperatūrā 8°-15°C [Keep away from light. Store at a temperature of 8°-15°C] (for mixtures, suspensions, ointments, drops taken internally) - white letters on a blue background;

23.3. "BĒRNAM" [FOR CHILDREN] (for medicinal products intended for children under 14 years of age) - black letters on a green background;

23.4. "Lietot uzmanīgi!" [Use with care] (for medicinal products which contain narcotic substances, atropine sulphate, silver nitrate, arsenious acid anhydride, sodium arsenate, dicaine, ephedrine, pseudo-ephedrine, phenobarbital, trihexyphenidyl) - red letters on a white background;

23.5. "Sargāt no uguns!" [Keep away from open flame] (for medicinal products which contain flammable or explosive substances) - white letters on a red background.

24. The labelling of medicinal products prepared by pharmacies shall contain the following notices and signal colours:

24.1. for orally administered medicinal products - green signal colour with a notice "IEKŠĶĪGI" [ORALLY] in white letters;

24.2. for externally administered medicinal products - orange signal colour with a notice "ĀRĪGI" [EXTERNALLY] in white letters;

24.3. for eye drops and eye ointments - pink signal colour with a notice "ACU PILIENI" [EYE DROPS] or "ACU ZIEDE" [EYE OINTMENT] in black letters.

25. The information referred to in Paragraph 22 of this Regulation shall be on the immediate or outer packaging, and such information shall be clearly legible, comprehensible and indelible.

26. The labelling shall be printed typographically or by using computer hardware. The labelling shall be attached to the immediate packaging (if this does not affect the quality of the medicinal product) or to the outer packaging of medicinal products.

VI. Division and Labelling of Industrially Manufactured Medicinal Products in a Pharmacy

27. A pharmacy the annex of the special authorisation (licence) of which contains the condition of the special activity - the preparation of medicinal products - shall be permitted to divide industrially manufactured medicinal products which are given to an individual patient according to a prescription issued by a medical practitioner and the amount of which in the packaging does not conform to the amount specified in the prescription. A pharmacy the appendix of the special licence of which does not contain the condition of the special activity - the preparation of medicinal products - shall be permitted to divide industrially manufactured medicinal products in conformity with the conditions specified in the prescription, provided that the immediate packaging of the medicinal product is not damaged.

[2 February 2016]

28. In dispensing medicinal products in conformity with Paragraph 27 of this Regulation, the pharmacist shall ensure the compliance of the labelling of the medicinal products with the requirements laid down in Paragraph 10 of this Regulation, as well as attach the package leaflet.

29. If unauthorised medicinal products in the Republic of Latvia, which are brought in on the basis of a prescription issued by a medical practitioner to an individual patient in accordance with Section 10, Sub-clause 7a of the Pharmaceutical Law, are dispensed to a patient, the pharmacist shall inform the patient regarding the instructions for use of the medicinal product referred to in Sub-paragraph 14.4 of this Regulation.

[2 February 2016]

VII. Supervision and Control

30. If there are changes in the labelling or package leaflet of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia which are related to the fulfilment of the requirements of this Regulation, but are not related to the changes in the summary of product characteristics, an application shall be submitted to the State Agency of Medicines by the marketing authorisation owner. A sample or layout of the immediate packaging and outer packaging of the medicinal product, and also a draft packaging leaflet shall be appended to the application. The State Agency of Medicines shall examine such application within one month after receipt thereof. If additional information is necessary, the State Agency of Medicines shall request such information in accordance with the procedures laid down in the Administrative Procedure Law, taking into account that the final decision must be taken within 90 days after the receipt of an application. If, within 90 days after submission of an application to the State Agency of Medicines, no decision is received that the State Agency of Medicines objects against the intended changes, the applicant may introduce the intended changes.

[21 December 2021]

31. The State Agency of Medicines shall examine the compliance of the translation of the text of the labelling into the official language with the information provided in the labelling of the medicinal product and the conformity of the translation of the package leaflet with the information provided in the package leaflet and the summary of product characteristics by the medicinal product manufacturer, as well as with the requirements laid down in this Regulation.

[2 February 2016]

32. Expenses which are related to checking the translation of the labelling and package leaflet of the medicinal products shall be included in authorisation fee of the medicinal products or in the fee for an authorisation for distribution of parallelly imported medicinal products, or in the fee for expert-examination of the application and documentation for the receipt of an authorisation for distribution of medicinal products authorised in a country of the European Economic Area, but not authorised in the Republic of Latvia which has been specified in the laws and regulations regarding the price list of paid services of the State Agency of Medicines.

[2 February 2016]

33. The implementation of this Regulation shall be controlled by the Health Inspectorate. In order to verify the performance of the requirements laid down in this Regulation, the Health Inspectorate and the State Agency of Medicines in conformity with their competence shall ensure operative mutual exchange of information.

[1 April 2008]

33.¹ The State Agency of Medicines shall carry out the tasks provided for the competent authority in accordance with the requirements laid down by Implementing Regulation No 198/2013.

[9 April 2013]

33.² The State Agency of Medicines shall be the competent authority referred to in Article 8 of Delegated Regulation No 2016/161.

[15 January 2019]

VIII. Closing Provisions

34. Cabinet Regulation No. 136 of 25 March 2003, Procedures for the Labelling of Medicinal Products and the Requirements to be Made for the Package Leaflet of Medicinal Products (Latvijas Vēstnesis, 2003, No. 49), is repealed.

35. In respect of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia which at the time of coming into force of this Regulation are on the market (released for free circulation) the requirements referred to in Paragraph 12 of this Regulation need not be applied until 31 December 2011.

36. In respect of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia which at the time of coming into force of this Regulation are on the market (released for free circulation) the requirements referred to in Paragraph 16 of this Regulation shall be applied not later than from 1 January 2007.

37. In respect of traditional herbal medicinal products, which were on the market (released for free circulation) prior to the coming into force of this Regulation, the requirements referred to in Paragraph 21 of this Regulation shall be implemented by 30 October 2012.

38. In respect of the medicinal products that are included in the Register of Medicinal Products of the Republic of Latvia and have been placed on the market the requirements laid down in Sub-paragraph 7.8 and Paragraphs 10, 14, 15, 17 and 19 of this Regulation shall be implemented by 30 October 2008.

39. The requirements referred to in Paragraph 9.¹ of this Regulation must be introduced by 1 May 2016.

[2 February 2016]

40. Sub-paragraph 10.16 and Paragraphs 12.¹, 12.², and 12.³ of this Regulation shall be applied from 9 February 2019 in conformity with the transitional measures specified in Articles 48 and 50 of Delegated Regulation No 2016/161.

[15 January 2019]

41. Until 31 December 2022, the requirements referred to in Paragraph 5 of this Regulation shall not be applied for the medicinal products included in the Register of Medicinal Products of the Republic of Latvia which temporarily but not longer than six months are not available in the packaging intended for the market of Latvia, but are in such packagings which are intended for another European Union Member State or a European Economic Area State where the authorisation documentation of such medicinal products is identical to the documentation of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia in conformity with the following conditions:

41.1. when supplying such medicinal products in retail, including to medical treatment institutions and social care institutions, at least one translation of the labelling and package leaflet of the relevant medicinal product in the official language shall be attached to the consignment of the particular medicinal product. When supplying such medicinal products to general type pharmacies, the translation of the labelling and package leaflet of the relevant medicinal product in the official language shall be attached to the consignment of the relevant medicinal product in the necessary amount;

41.2. when handing out such medicinal products to a customer of a general type pharmacy, a pharmacist shall inform him or her that the medicinal product is identical to the medicinal product authorised in Latvia but is not in the packaging intended for the market of Latvia and that package leaflet of the medicinal product in the official language is not placed in the packaging, and also shall hand out the package leaflet in the official language, attaching it to the packaging;

41.3. supply of such medicinal products to general type pharmacies is permitted only in the case if other analogues of the medicinal products included in the Register of Medicinal Products of the Republic of Latvia are not available on the market of Latvia.

[21 December 2021]

42. If the marketing authorisation owner places on the market the medicinal products referred to in Paragraph 41 of this Regulation, it shall notify the State Agency of Medicines of the amount, batch number, expiry date, country for the market of which the medicinal products are intended, and the duration of the distribution thereof, and also the reasons why it is not possible to re-package the medicinal products.

[9 June 2020]

43. Until 31 December 2023, the requirements referred to in Paragraph 4 of this Regulation shall not be applied to the medicinal products authorised in Latvia and included in the Register of Medicinal Products of the Republic of Latvia which are involved in the trial project of electronic package leaflet (hereinafter - the pilot project) organised by the competent authorities of the Baltic countries (Estonia, Latvia, Lithuania) and are intended for use in the inpatient medical treatment institution.

[21 December 2021]

44. The State Agency of Medicines shall publish the information on the medicinal products which are included in the pilot project referred to in Paragraph 43 of this Regulation on the website thereof, indicating the name, strength or concentration, pharmaceutical form, the name and country of the marketing authorisation owner, the marketing authorisation number.

[21 December 2021]

45. The medicinal products which are included in the pilot project referred to in Paragraph 43 of this Regulation and the batch output of which has been made until 31 December 2023 may be distributed at the inpatient medical treatment institution until the end of the expiry date thereof.

[21 December 2021]

46. If the marketing authorisation owner included in the pilot project referred to in Paragraph 43 of this Regulation discontinues the participation in it, the marketing authorisation owner shall, without delay, electronically inform the State Agency of Medicines thereof. The marketing authorisation owner is responsible for the production of the next batch of medicinal products and the output thereof in accordance with Paragraph 4 of this Regulation.

[21 December 2021]

47. The State Agency of Medicines shall exclude medicinal products from the pilot project referred to in Paragraph 43 of this Regulation within three working days after receipt of the information referred to in Paragraph 46 of this Regulation and update the information on its website without delay.

[21 December 2021]

48. The marketing authorisation owner of the medicinal products included in the pilot project referred to in Paragraph 43 of this Regulation shall be responsible for the fulfilment of the requirements of this Regulation.

[21 December 2021]

49. Until 31 December 2026, the requirements referred to in Paragraph 4 of this Regulation shall not be applied to the medicinal products authorised in Latvia and included in the Register of Medicinal Products of Latvia which are involved in the pilot project referred to in Paragraph 43 of this Regulation and are intended for use in the inpatient medical treatment institution.

[12 March 2024]

50. The medicinal products which are included in the pilot project referred to in Paragraph 43 of this Regulation and the batch output of which has been made until 31 December 2026 may be distributed at the inpatient medical treatment institution until the end of the expiry date thereof.

[12 March 2024]

Informative Reference to the European Union Directives

[9 April 2013; 30 July 2013; 15 January 2019]

This Regulation contains legal norms arising from:

1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;

2) Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

3) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;

4) Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

5) Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance;

6) Directive 2011/62/EU of the European Union and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

Prime Minister A. Kalvītis

Minister for Health G. Bērziņš

Annex
Cabinet Regulation No. 57
17 January 2006

[12 March 2024]

Excipients and Information for the Package Leaflet

Translation © 2024 Valsts valodas centrs (State Language Centre)