ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of July 2, 1997 No. 603

About approval of the Regulations on pricing on medicines and other pharmaceutical and parapharmaceutical products

In pursuance of the Law No. 1409-XIII of December 17, 1997 on drugs (The official monitor of the Republic of Moldova, 1998, No. 52-53, of the Art. 368) and the Law No. 1456-XII of May 25, 1993 on pharmaceutical activities (repeated publication: The official monitor of the Republic of Moldova, 2005, No. 59-61, of the Art. 200) DECIDES: the Government

Approve Regulations on pricing on drugs and other pharmaceutical and parapharmaceutical products according to appendix.

Appendix

to the Order of the Government of the Republic of Moldova of July 2, 1997 No. 603

Regulations on pricing on drugs and other pharmaceutical and parapharmaceutical products *

I. General provisions

1. This provision is developed according to the Law No. 1409-XIII of December 17, 1997 on drugs (The official monitor of the Republic of Moldova, 2005, No. 52-53, of the Art. 368), 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) and the Order of the Government of the Republic of Moldova N 547 of August 4, 1995. "About measures for streamlining and state regulation of the prices (rates)" (The official monitor, 1995, Art. N53-54, 426) the Order of the Government No. 525 of June 22, 2010. "About approval of the Regulations on approval procedure and registration of the prices of the producer for drugs" (The official monitor of the Republic of Moldova, 2010, No. 105-106, of the Art. 582) also is obligatory for accomplishment by all pharmaceutical companies (producers, warehouses, drugstores and their branches) in the territory of the Republic of Moldova, irrespective of their type of property and form of business.

2. In this Provision the following concepts are determined:

purchase price - the price of the foreign producer, less the amount of the provided commercial discount (discount) specified in source documents which cannot exceed the price of the producer registered in the National price catalog of the producer on drugs, taking into account the made customs payments, the incurred transportation expenses (as necessary, depending on delivery conditions) and payments for quality control of medicines, counted in national currency (lei), according to the official exchange rate established by National Bank of Moldova on the date of carrying out customs procedures;

commercial discount (discount) - reduction of price of producer/software supplier to prior consent of the parties in accordance with the terms, provided in the agreement;

selling price - the price at which the domestic manufacturer sells medicines in the territory of the Republic of Moldova in which calculation the standard rate of profitability on the company to 15 percent is provided;

wholesale price - the price which is applied in case of wholesale from warehouses of medicines to drugstores and medical institutions;

retail price - the price which is applied by drugstore in case of retail sale to the final consumer.

II. Procedure for pricing

3. The prices of medicines and other pharmaceutical and parapharmaceutical products (in subsequent - medicines) are established by the pharmaceutical companies as follows:

the medicines made in the Republic of Moldova are sold in the domestic market on selling prices, using the trade allowance. At the expense of the trade allowance operating, investment and financial expenses are covered;

the imported medicines are implemented in the territory of the Republic of Moldova on purchase price, using the trade allowance.

The trade discount (discount) provided by the supplier is determined according to the National accounting standards approved by the Ministry of Finance.

3-1. Domestic manufacturers implement in the territory of the Republic of Moldova the issued medicines on selling prices taking into account the standard rate of profitability on the company to 15 percent of cost of sales, business expenses, total and administrative expenses, other operating expenses connected with production and realization of medicines according to the National accounting standard 3 "Structure of costs and expenses of the company" with the accruing result from the beginning of the accounting period.

The cost of sales and operating expenses connected with realization of medicines in the domestic market separate from cost of sales and total operating expenses by quantitative method using expense allocation coefficient.

4. In case of realization of medicines application of the trade allowance to 40 percent to selling price or to purchase price is allowed, including:

to 15 percent - for the companies which import and/or extend wholesale medicines, both import, and domestic;

to 25 percent - for drugstores and their branches.

5. It is excluded

6. It is excluded

7. In case of realization of medicines the pharmaceutical companies specify in source documents with the special mode selling price of drugs of national production or purchase price the imported medicines, the size of the applied trade allowance, serial number of the goods, number and document date confirming quality, issued by the Agency on drugs.

III. Procedure of payments of the prices of realization of drugs, other medicinal and pharmaceutical medicines

8. Prices of medicines are established by the pharmaceutical companies and organizations of the Republic of Moldova (producers, warehouses, drugstores and their branches) according to the Regulations on approval procedure and registration of the prices of the producer of drugs approved by the Order of the Government No. 525 of June 22, 2010.

9. The payment for quality control of drugs is calculated according to the List of the paid services rendered by the National institute of pharmacy approved by the Order of the Government No. 1135 of September 18, 2003. "About approval of payment for issue of permissions to application of drugs, other pharmaceutical and parapharmaceutical products and for changes after registration" (The official monitor of the Republic of Moldova, 2003, No. 204-207, of the Art. 1186).

10. It is excluded

11. Initial base for application of the trade allowance by the pharmaceutical companies which implement import medicines is purchase price.

Initial base for application of the trade allowance by the pharmaceutical companies realizing domestic medicines is selling price.

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