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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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Text consolidated by Valsts valodas centrs (State Language Centre) with amending regulations of:

28 May 2013 [shall come into force from 1 June 2013];
3 May 2016 [shall come into force from 7 May 2016].

If a whole or part of a paragraph has been amended, the date of the amending regulation appears in square brackets at the end of the paragraph. If a whole paragraph or sub-paragraph has been deleted, the date of the deletion appears in square brackets beside the deleted paragraph or sub-paragraph.


Republic of Latvia

Cabinet
Regulation No. 610
Adopted 2 August 2011

Criteria for the Location of Pharmacies and Pharmacy Branches

Issued pursuant to
Section 5, Clause 16 of the Pharmacy Law

1. This Regulation prescribes the criteria for the location of pharmacies and pharmacy branches (except for veterinary pharmacies), which shall be taken into account when issuing a special permit (licence) for the opening (operations) a pharmacy.

2. The maximum permissible number of general type pharmacies in a populated area shall be calculated using the following formula:

A =

P

+ k, where

S


A - the maximum permissible number of pharmacies;

P - the number of inhabitants in the populated area;

S - the minimum number of inhabitants per pharmacy;

k - correction coefficient.

3. The minimum number of inhabitants per pharmacy and the correction coefficient depending on the number of inhabitants in the populated area has been specified in Annex to this Regulation. If the number of inhabitants is 4000 or less, two pharmacies may be opened in the relevant populated area.

4. A general type pharmacy outside a populated area may not be opened within a radius of five kilometres from an already functioning general type pharmacy. A pharmacy branch may not be opened within a radius of five kilometres from an already functioning general type pharmacy or pharmacy branch.

4.1 A general type pharmacy in a populated area is opened taking into account the conditions for distance referred to in Paragraph 6 of this Regulation.

[28 May 2013]

5. A closed type pharmacy shall be located within the territory of the inpatient medical treatment institution, which has opened the relevant pharmacy.

6. Relocation of a general type pharmacy (except the pharmacies referred to in Paragraph 14 of this Regulation) is permitted, based on the existing special permit (licence), within the borders of one populated area where there is no functioning general type pharmacy within a radius of 500 metres, with the accuracy of at least two metres, where medicinal products are prepared or which operates 24 hours a day.

[28 May 2013; 3 May 2016]

6.1 The condition regarding a radius of 500 metres referred to in Paragraph 6 of this Regulation shall not be applicable when relocating a general type pharmacy:

6.1 1. to a medical treatment institution in accordance with Paragraph 18.4 of this Regulation;

6.1 2. within one building registered in the National Real Estate Cadastre Information System (also when there are several groups of premises with different addresses in the building);

6.1 3. within the radius of 50 metres of the address of the place of pharmaceutical activity specified in the special permit (licence) not more than once every five years.

[3 May 2016]

7. The distances referred to in Paragraphs 4, 6, and 18.1 of this Regulation shall be determined in the map the scale of which ensures unambiguous identification of the objects and determination of the distance with an accuracy of at least two metres. The measurement shall be performed along an imaginary straight line between the middle points of the pharmacy entrances intended for visitors of pharmacies. The proposer of the relocation of a general type pharmacy shall submit the floor plan of the building in which the pharmacy is situated, indicating the middle of the entrance of a general type pharmacy, for the performance or verification of measurements. If the building in which the location of a general type pharmacy is planned is not registered in the National Real Estate Cadastre Information System, the topographical plan of its location shall be submitted.

[28 May 2013]

8. When performing an assessment of access to pharmaceutical care in a specific populated area, the local government has the right to file an application with the State Agency of Medicines regarding the need for a general type pharmacy in the part of a populated area (where in compliance with the criteria referred to in Paragraphs 2 and 3 of this Regulation there is a sufficient number of general type pharmacies) where there is no functioning general type pharmacy within a radius of three kilometres.

9. When performing an assessment of access to pharmaceutical care in a specific populated area, the local government has the right to file an application with the State Agency of Medicines regarding the need to open a general type pharmacy which operates 24 hours a day (hereinafter - 24-hour pharmacy), in a specific populated area where in compliance with the criteria referred to in Paragraphs 2 and 3 of this Regulation there is a sufficient number of general type pharmacies but where there is no functioning general type 24-hour pharmacy.

10. The State Agency of Medicines shall evaluate the information provided in the application of the local government referred to in Paragraph 8 or 9 of this Regulation and provide an answer to the local government within 15 days, confirming or rejecting, with justification, the compliance of the information indicated in the application with the information at the disposal of the State Agency of Medicines regarding the fulfilment of the criteria referred to in Paragraph 8 or 9 of this Regulation in the specific populated area or part of a populated area. The State Agency of Medicines shall insert information on the Internet site of the State Agency of Medicines regarding the applications of local governments in which the indicated information regarding the location of pharmacies complies with the information at the disposal of the State Agency of Medicines.

11. After receipt of the confirmation from the State Agency of Medicines referred to in Paragraph 10 of this Regulation regarding the compliance of the specific part of the populated area with the criteria referred to in Paragraph 8 of this Regulation, the local government has the right to announce a tender for the opening of a new general type pharmacy in the part of the populated area in question. The tender shall be announced on the Internet site of the local government.

12. If several merchants offering the same range of services and period of commencement of operations have applied for the tender referred to in Paragraph 11 of this Regulation, the applicant who does not have a pharmacy or who from the applying merchants has the least number of pharmacies in the specific populated area shall be given a priority to file an application with the State Agency of Medicines for the issue of a special permit (licence) for the opening (operations) of a general type pharmacy. If several applicants equally meet the conditions in question, priority shall be given to the applicant according to the consecutive order in which the applications were registered. The local government shall inform the State Agency of Medicines regarding the consecutive order in which the applications of applicants were registered.

13. If no merchant has applied to open a new general type pharmacy within 30 days from the day when the tender referred to in Paragraph 11 of this Regulation was announced, or if the merchant referred to in Paragraph 12 of this Regulation has not filed an application with the State Agency of Medicines within 30 days from the closing date of the tender for the issue of a special permit (licence) for the opening (operations) of a general type pharmacy, the local government has the right to file an application with the State Agency of Medicines for the issue of a special permit (licence) for the opening (operations) of a general type pharmacy in its administrative area, in accordance with the regulatory enactments regarding the licensing of pharmaceutical activities.

14. It is prohibited to relocate a general type pharmacy, the special permit (licence) of which has been issued on the basis of the conditions referred to in Paragraph 12 or 13 of this Regulation.

15. After receipt of the confirmation from the State Agency of Medicines referred to in Paragraph 10 of this Regulation regarding the compliance of the specific populated area with the criteria referred to in Paragraph 9 of this Regulation, the local government has the right to announce a tender for the opening of a new general type 24-hour pharmacy in the populated area in question. The tender shall be announced on the Internet site of the local government.

16. If several merchants offering the same time of commencement of operations of a 24-hour pharmacy have applied to the tender referred to in Paragraph 15 of this Regulation, the State Agency of Medicines shall examine the applications for re-registration of a special permit (licence) for opening (operations) a general type pharmacy with a condition of special operation "works 24 hours a day" and a confirmation regarding the provision of 24-hour operations for at least three years from the day of re-registration of the licence, according to the consecutive order in which the applications were registered. The local government shall inform the State Agency of Medicines regarding the consecutive order in which the applications of applicants were registered.

17. If no merchant has applied to open a new general type pharmacy within 30 days from the day when the tender referred to in Paragraph 15 of this Regulation was announced, or if none of the merchants referred to in Paragraph 16 of this Regulation have filed an application with the State Agency of Medicines within 30 days from the closing date of the tender for re-registration of a special permit (licence) for the opening (operations) of a general type pharmacy with the conditions referred to in Paragraph 16 of this Regulation, the local government has the right to announce a tender for the opening (operations) of a general type 24 hour pharmacy in this populated area. The tender shall be announced on the Internet site of the local government. The results of the tender shall be evaluated in compliance with the procedures referred to in Paragraph 12 of this Regulation.

18. If no merchants have applied for the tender referred to in Paragraph 17 of this Regulation within 30 days from the day when the tender was announced, the local government has the right to file an application with the State Agency of Medicines for the issue of a special permit (licence) for opening (operations) a general type pharmacy in its administrative area with a condition of special operation "works 24 hours a day" indicating that the local government will provide 24-hour operations for at least three years from the day of issue of the licence.

18.1 When performing an assessment of access to pharmaceutical care in a specific populated area, the local government may propose to relocate a general type pharmacy to a medical treatment institution by submitting a relevant application to the State Agency of Medicines. The attestation regarding the compliance of the relevant medical treatment institution with the criteria referred to in Paragraph 18.2 of this Regulation and the confirmation of the medical treatment institution that it agrees to the opening of the general type pharmacy and undertakes to ensure it with the premises for not less than three years from the day of issuing of the special permit (licence) to the general type pharmacy shall be appended to the application.

[28 May 2013]

18.2 The medical treatment institution to which the general type pharmacy is relocated in accordance with the procedures laid down in Paragraph 18.1 of this Regulation shall conform to the following criteria:

18.2 1. there has been no functioning general type pharmacy during the last three years;

18.2 2. there are consulting rooms of doctors of at least 10 different specialities with practicing specialists who ensure consulting of patients for not less than 20 hours per week in each speciality;

18.2 3. accessibility of the environment is ensured (the entrance is suitable for entering with a wheelchair and baby stroller);

18.2 4. there is no general type pharmacy in the radius of 50 metres.

[28 May 2013]

18.3 The State Agency of Medicines shall evaluate the information provided in the application of the local government referred to in Paragraph 18.1 of this Regulation and provide an answer to the local government within 15 days, confirming or rejecting, with justification, the compliance of the information indicated in the application with the information at the disposal of the State Agency of Medicines regarding the existence of a general type pharmacy in the specific medical treatment institution and the compliance of the medical treatment institution with the requirements referred to in Paragraph 18.2 of this Regulation. The State Agency of Medicines shall insert information on the Internet site of the State Agency of Medicines regarding the applications of local governments in which the indicated information regarding the location of pharmacies complies with the information at the disposal of the State Agency of Medicines.

[28 May 2013]

18.4 After receipt of a positive evaluation of the State Agency of Medicines referred to in Paragraph 18.3 of this Regulation, the local government may announce a tender on its web site for the relocation of a general type pharmacy to a specific medical treatment institution. Only such general type pharmacy may participate in the tender which has entered into a contract with the National Health Service regarding the distribution of reimbursable medicinal products and medical devices intended for out-patient medical treatment and which ensures the distribution of narcotic and psychotropic medicinal products, and also distribution of medicinal products recognised as narcotic analgesic agents by the State Agency of Medicines. The local government shall evaluate the results of the tender and inform the State Agency of Medicines regarding the applicant who has won the relevant tender. The applicant is entitled to submit an application regarding re-registration of the special permit (licence) within 30 days from the closing date of the tender.

[28 May 2013]

18.5 If the applicant referred to in Paragraph 18.4 of this Regulation fails to submit an application regarding re-registration of the special permit (licence) within 30 days from the closing date of the tender, the local government shall give the right to relocate a general type pharmacy to a medical treatment institution to the next applicant who had applied for the tender and who conforms to the criteria referred to in Paragraph 18.6 of this Regulation. The local government shall notify the State Agency of Medicines of the applicant who has the right to be the next one to submit an application regarding the re-registration of the special permit (licence). The applicant is entitled to submit an application regarding re-registration of the special permit (licence) within 30 days from the sending of notification of the local government. If the applicant fails to submit the application regarding re-registration of the special permit (licence) within the abovementioned time period, the local government shall announce a new tender in accordance with Paragraph 18.4 of this Regulation.

[28 May 2013]

18.6 If several merchants offering the same time of commencement of operations have applied to the tender referred to in Paragraph 18.4 of this Regulation, the applicant who conforms to at least one of the following criteria (in order of priority) shall be given a priority to submit an application to the State Agency of Medicines regarding the re-registration of the special permit (licence):

18.6 1. the general type pharmacy of the applicant is the nearest to the medical treatment institution to the premises of which the local government has proposed to relocate the general type pharmacy in accordance with Paragraph 18.1 of this Regulation;

18.6 2. the applicant has the least number of general type pharmacies in the specific populated area;

18.6 3. the general type pharmacy of the applicant has a branch of a pharmacy in a municipality, a municipality town or a municipality rural territory where the number of inhabitants does not exceed 4000.

[28 May 2013]

19. This Regulation shall not apply to operations and repeated licensing (re-registration of a special permit (licence)) of those general type pharmacies, which prior to the date of coming into force of this Regulation have received a special permit (licence) for opening (operations) a pharmacy and which operate in compliance with the requirements of regulatory enactments.

20. Cabinet Regulation No. 102 of 5 March 2002, Criteria for the Location of Pharmacies and Pharmacy Branches (Latvijas Vēstnesis, 2002, No. 47; 2006, No. 177) is repealed.

Acting for the Prime Minister,
Minister for Justice,
Acting for the Minister for the Interior A. Štokenbergs

Minister for Health J.Bārzdiņš

 

Annex
Cabinet Regulation No. 610
2 August 2011

Minimum Number of Inhabitants Per Pharmacy and Correction Coefficient According to the Number of Inhabitants in a Populated Area

No.

Number of inhabitants in a populated area

Minimum number of inhabitants per pharmacy

Correction coefficient

1.

up to 4000

-

-

2.

4001.-7000

2500

-

3.

7001.-10,000

3000

0.5

4.

10,001.-15,000

3500

1.0

5.

15,001.-30,000

4000

1.0

6.

30,001.-50,000

4500

2.0

7.

50,001.-100,000

5000

2.5

8.

100,001 and more

5500

5.0

Minister for Health J.Bārzdiņš

 


Translation © 2018 Valsts valodas centrs (State Language Centre)

 
Document information
Status:
In force
in force
Issuer: Cabinet of Ministers Type: regulation Document number: 610Adoption: 02.08.2011.Entry into force: 12.08.2011.Publication: Latvijas Vēstnesis, 125, 11.08.2011.
Language:
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