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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of May 26, 2014 No. 348

About rates for the services provided by the Agency on drugs and medical products

(as amended of the Order of the Government of the Republic of Moldova of 10.10.2016 No. 1130)

Based on article 12 of the Law No. 847-XIII of May 24, 1996 on the budget system and the budget process (repeated publication: The official monitor of the Republic of Moldova, 2005, special release), with subsequent changes and amendments, article 11-1 of the Law No. 1456-XII of May 25, 1993 on pharmaceutical activities (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes and amendments, article 7 of the Law on drugs No. 1409-XIII for December 17, 1997 (The official monitor of the Republic of Moldova, 1998, Art. No. 52-53, 368), with subsequent changes and amendments, article 31 of the Law No. 92 of April 26, 2012 on medical products (The official monitor of the Republic of Moldova, 2012, Art. No. 149-154, 480) DECIDES: the Government

1. Approve:

Regulations on rates for the services provided by the Agency on drugs and medical products according to appendix No. 1;

The catalog and rates for the services provided by the Agency on drugs and medical products according to appendix No. 2.

2. Determine that the Agency on drugs and medical products will calculate rates for the provided services based on actual expenses, according to Regulations on rates for the provided services, conferring on itself responsibility for correctness of calculations and quality of the provided services.

3. To the Ministry of Health to exercise control over application of the Catalogue and rates for the paid services provided by the Agency on drugs and medical products and to provide updating of the Catalogue on the basis of the rates arriving from the Agency on drugs and medical products with the subsequent provision to their Government for consideration and approval.

4. Recognize invalid some orders of the Government, according to appendix No. 3.

Prime Minister

Iurie Leanca

Countersign:

deputy. Prime Minister, Minister of Economic Affairs

 

Valeriu Lazer

Minister of Finance

Anatol Arapu

Minister of Health

Andrey Usaty

Appendix No. 1

to the Order of the Government of the Republic of Moldova of May 26, 2014 No. 348

Regulations on rates for the services provided by the Agency on drugs and medical products

I. General provisions

1. The regulations on rates for the services provided by the Agency on drugs and medical products (further - the Provision) are developed according to the existing national legal system, international conventions and agreements which party the Republic of Moldova is and determine procedure of payments and establishments of rates for the services provided by the Agency on drugs and medical products (further - the Agency).

2. This Provision determines:

1) method of calculation, approval, change and application of rates for the services provided by the Agency;

2) basic elements of rates for the rendered services;

3) cost structure, the rates included in cost of calculation;

4) method and directions of use of special means.

3. When calculating rates the following requirements are observed:

1) rates for services are based on the actual expenses incurred on their rendering;

2) rates are established by the principle of nondiscrimination of service providers and consumers;

3) establishment of rates shall be transparent and be made public;

4) all procedures and rates correspond to the current legislation.

II. Application of this provision. Procedure for review of rates

4. The agency calculates rates according to this Provision, provides them to the Ministry of Health, having attached necessary documents for their reasons, and bears responsibility for accuracy of the data and calculations.

5. The document package represented to the Ministry of Health includes:

1) the list and rates for the services provided by the Agency;

2) calculation of new rates;

3) accounting/statistic reports;

4) reasons;

5) other necessary information requested by the Ministry of Health.

III. Methodology of establishment of rates for the services provided by the Agency

6. The methodology of establishment of rates for the services provided by the Agency (further - Methodology) is developed according to provisions of article 12 of the Law No. 847-XIII of May 24, 1996 on the budget system and the budget process and other existing regulations. The mechanism used in case of establishment and regulation of rates is based on the matching principle of rates to the following criteria:

1) covering of the direct and indirect costs necessary for rendering services;

2) forming of rates on the basis of the actual expenses incurred by the Agency.

7. The principle of domination of actual costs provides that rates for the services provided by the Agency are based on their cost.

8. The cost of the rendered services consists of the following basic elements:

1) expenses on compensation of personnel, including compensation of group of external experts (in case of rendering services in examination of documentation for authorization of medicines, dietary supplements and medical products);

2) budget payments of compulsory social insurance and the budget of compulsory medical insurance, including budget payments of compulsory social insurance and the budget of compulsory medical insurance for group of external experts (in case of rendering services in examination of documentation for authorization of medicines, dietary supplements and medical products);

3) expenses on medicines and consumable materials;

4) expenses on the invaluable and fast-wearing-out objects (MBP) / and expenses for soft stock;

5) depreciation of fixed assets;

6) other indirect expenses.

The cost of rates does not join the following expenses connected with:

1) accomplishment of scientific research works;

2) capital investments in construction, the equipment and stock;

3) repair of fixed assets;

4) repair and maintenance of the social and cultural objects and other objects which are not connected with the main activities of organization;

5) rendering financial or financial aid to other organizations;

6) losses, thefts, sanctions and penalties.

9. Financial accounting of the expenses connected with the provided services is conducted by the Agency according to the current legislation.

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