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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of October 31, 2018 No. 776

About marginal registration of selling prices of producers for medicines

According to subitem 2.1 of Item 2 of the Presidential decree of the Republic of Belarus of August 22, 2018 "About registration of the prices of medicines" the Council of Ministers of the Republic of Belarus DECIDES: No. 345

1. Create the marginal state register of selling prices of producers on medicines.

2. Approve enclosed:

Regulations on marginal order of registration of selling prices of producers on medicines;

Regulations on procedure for maintaining the marginal state register of selling prices of producers on medicines.

3. This resolution becomes effective after its official publication.

Prime Minister of the Republic of Belarus

S. Rumas

Approved by the Resolution of Council of Ministers of the Republic of Belarus of October 31, 2018 No. 776

Regulations on marginal order of registration of selling prices of producers on medicines

1. This Provision establishes marginal order of registration of selling prices of the organizations performing production of medicines (further - producers) concerning which the Presidential decree of the Republic of Belarus of August 22, 2018 No. 345 "About registration of the prices of medicines" (The national legal Internet portal of the Republic of Belarus, 25.08.2018, 1/17898) need of such registration is established.

2. For the purposes of this provision terms and their determinations in the values established by the Law of the Republic of Belarus of July 20, 2006 "About medicines" are used (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258), and also the following terms and their determinations:

the holder of the registration certificate on medicine - the legal entity or the individual entrepreneur to whom in the procedure established by the legislation the registration certificate on medicine is issued;

marginal selling price of the producer on medicine (further, unless otherwise specified, - marginal selling price) - calculated according to the technique determined by the Ministry of anti-monopoly regulation and trade in coordination with the Ministry of Health (further - technique), the price which size is limited to upper limit and is subject to registration.

3. Marginal registration of selling prices is performed by the Ministry of Health (further - the Ministry of Health).

Marginal selling prices are registered in Belarusian rubles. The payment for marginal registration of selling prices is not levied.

4. For marginal registration of selling price by the holder of the registration certificate for medicine (authorized by it person) (further-) it are represented to the republican unitary enterprise "The Center of Examinations and Testing in Health Care" to RUP "The Center of Examinations and Testing in Health Care" in duplicate on paper:

4.1. the statement for marginal registration of selling price of the producer for medicine in form according to appendix (further - the statement). Data are specified in the statement according to the registration certificate and the registration file on medicine on date of filing of application;

4.2. the documents confirming the power of the person which submitted the application;

4.3. copy of the license for production of medicines;

4.4. the copy of the registration certificate on medicine;

4.5. the documents prepared taking into account requirements and according to the forms determined by technique;

4.6. the list of the sources of information (the websites on the global computer Internet) containing data on selling prices of the producer on medicine in the countries according to the list determined by technique or the documents confirming the extent of such selling prices. The specified sources of information shall conform to the following requirements:

the source of information shall contain data on the organization responsible for placement of data on the prices of medicines;

as source of information the data on the prices of the medicines delivered at the expense of international financial institutions (funds) for the decision of the World Health Organization and (or) determined on the basis of special agreements concerning supply of medicine in case of documentary confirmation of availability of such agreements are not used.

Information placed in the specified sources shall:

be public;

allow to identify necessary characteristics of medicines for the purpose of comparison of data on the declared medicine and medicine, the price which is specified in the used information source;

contain data on the price of medicine and currency in which it is provided.

5. The documents submitted for marginal registration of selling price in foreign language move on paper with the translation into Russian or Belarusian certified in accordance with the established procedure.

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