PRESIDENTIAL DECREE OF THE REPUBLIC OF BELARUS

of December 31, 2019 No. 499

About drug circulation

For the purpose of ensuring protection of health of the population, quality assurance and safety of medicines, enhancement of provision of medicines and state regulation of drug circulation I decide:

1. To the Ministry of Health till May 1, 2020 to create public institution "The state pharmaceutical supervision in the sphere of drug circulation Gosfarmnadzor (further - organization) and to provide its functioning.

2. Determine that:

2.1. the organization is under supervision of the Ministry of Health.

The organization is headed by the director appointed to position and dismissed by the Minister of Health.

The charter of organization, the changes and (or) amendments made to it, structure of organization and the number of staff of his workers affirm the Ministry of Health.

The property of organization is in republican property and belongs to it on the right of operational management;

2.2. financing of expenses on creation and content of organization is performed according to the procedure, determined by the Ministry of Health, for the account:

the target assignments made by RUP "The Center of Examinations and Testing in Health Care", RUP "BELFARMATsIYa", the Brest RUP "Pharmacy", Vitebsk Pharmation Unitary Enterprise, Gomel Pharmation Unitary Enterprise, the Grodno RUP "Pharmacy", the Mogilev RUP "Pharmacy", RUP "Minsk Pharmacy" (further - target assignments);

other sources which are not forbidden by the legislation;

2.3. target assignments:

join the companies specified in the paragraph the second subitem 2.2 of this Item in structure of costs (expenses) on production and sales of goods (works, services), the property rights considered in case of the taxation;

are transferred into the current (settlement) bank account of organization.

Tax amounts on value added on the acquired (imported) goods (works, services), property rights due to target assignments are not deductible and belong on value addition of the acquired (imported) goods (works, services), property rights.

The procedure for forming and use of target assignments is determined by the Ministry of Health;

2.4. the main objectives of organization are:

prevention of receipt in the address and timely retirement of low-quality, counterfeited medicines and medicines expired;

prevention, identification and suppression of violations of requirements of the legislation on drug circulation;

2.5. the organization is body of the state pharmaceutical supervision of observance by legal entities and individual entrepreneurs of requirements of the legislation on drug circulation, including regarding conditions of industrial production, pharmaceutical production, realization, storage, transportation and medical application in the organizations of health care of medicines (further - the state pharmaceutical supervision);

2.6. the state pharmaceutical supervision is carried out in the form of selective, unscheduled inspections, monitoring and other measures of preventive and precautionary nature, actions technical (technological, testing) nature.

When implementing the state pharmaceutical supervision are researched:

rooms, equipment, gages, vehicles, engineering systems;

work types and the services connected with industrial production of medicines, their pharmaceutical production, leave and realization;

quality, efficiency and safety of medicines;

the documents used when implementing pharmaceutical activities.

When holding actions technical (technological, testing) nature within implementation of the state pharmaceutical supervision sampling of medicines at all stages of their address is made.

3. Determine that:

3.1. medicines (appendix 1) are subject to state registration in the simplified procedure;

3.2. owners of customs, free warehouses on which storage of medicines is performed the owners of warehouses of temporary storage, other persons performing temporary storage of medicines, and also persons performing storage of the medicines placed under customs procedure of customs warehouse in the places which are not customs warehouses provide storage of medicines according to the Rules of proper distributor practice within the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 80.

Persons listed in part one of this subitem shall undergo inspection on compliance to Rules of proper distributor practice within the Eurasian Economic Union that is confirmed by the positive conclusion issued by the Ministry of Health by its results.

In the absence of the positive conclusion provided in part two of this subitem, the State Customs Committee makes the decision on prohibition of storage of medicines on representation of the Ministry of Health;

3.3. the legal entities and individual entrepreneurs performing pharmaceutical activities shall observe the proper pharmaceutical practicians in the sphere of drug circulation approved according to the international legal acts constituting the right of the Eurasian Economic Union;

3.4. quality control of the medicines imported on the territory of the Republic of Belarus is exercised before their receipt in realization by the test laboratories accredited in the National accreditation system of the Republic of Belarus for testing of medicines (further - test laboratories), after selection by them is model in warehouses of the legal entities performing import of medicines to the territory of the Republic of Belarus for their further realization.

Quality control of the medicines which are in circulation is performed by test laboratories (except for the test laboratories which were carrying out quality control to their receipt to realization) after sampling within implementation of the state pharmaceutical supervision.

4. Make changes to presidential decrees of the Republic of Belarus (appendix 2).

5. To Council of Ministers of the Republic of Belarus in three-months time:

5.1. determine the simplified procedure of state registration of medicines providing including:

carrying out complex of the preliminary technical works preceding state registration within no more than 30 working days from the date of the conclusion of the contract between the applicant and RUP "The Center of Examinations and Testing in Health Care";

total amount of expenses of the applicant on the state registration of medicines which is not exceeding 120 basic sizes excluding tax on value added;

5.2. provide when implementing ministerial procedure on quality control of medicine of foreign production and issue of the test report of this medicine before its realization obligatory representation of one of the following documents (document package):

the agreement (contract) of purchase and sale signed with the producer or the holder of the registration certificate of medicine;

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