RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of October 27, 2020 No. 611

About change of resolutions of Council of Ministers of the Republic of Belarus

Based on parts eight, the tenth, twelfth and twenty fifth article 10 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" and in pursuance of paragraph two of article 2 of the Law of the Republic of Belarus of May 13, 2020 No. 13-Z "About change of the Law of the Republic of Belarus "About medicines" the Council of Ministers of the Republic of Belarus DECIDES: No. 161-Z

1. Make changes to the following resolutions of Council of Ministers of the Republic of Belarus:

1.1. in the resolution of Council of Ministers of the Republic of Belarus of September 23, 2008 No. 1397 "About some questions of procedure for movement of separate types of goods through Frontier of the Republic of Belarus":

to state subitem 1.40 of Item 1 in the following edition:

"1.40. The regulations on procedure and conditions of issue by the Ministry of Health of the conclusions (allowing documents) for import to the territory of the Republic of Belarus of medicines (are applied);";

The regulations on procedure and conditions of issue by the Ministry of Health of the conclusions (allowing documents) for import of the medicines, pharmaceutical substances limited to movement through Frontier of the Republic of Belarus on the bases of non-economic nature, approved by this resolution to be reworded as follows (are applied);

1.2. in Item 8 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446:

add Item with subitem 8.3-1 of the following content:

"8.3-1. establishes procedure and conditions of medical application of original medicines for ensuring early access for patients to new methods of treatment;";

state subitems 8.14-8.14-3 in the following edition:

"8.14. performs state registration (confirmation of state registration) of medicines, conditional state registration (confirmation of conditional state registration) of medicines, state registration of medicines in the simplified procedure, modification of the registration file, forming of the State register of medicines of the Republic of Belarus, and also registration (registration confirmation) and other procedures connected with registration of medicines within the Eurasian Economic Union;

8.14-1. determines:

complex of the preliminary technical works connected with conducting examinations, approbations of techniques of quality control of medicine and quality control of this medicine with use of such techniques, other researches, preceding state registration (confirmation of state registration) of medicines, conditional state registration (confirmation of conditional state registration) of medicines, state registration of medicines in the simplified procedure, to modification of the registration file, procedure for the organization and carrying out these works;

complex of the examinations performed in case of registration (registration confirmation) and other procedures connected with registration of medicines within the Eurasian Economic Union, procedure for their organization and carrying out;

procedure for technical supply of maintaining the State register of medicines of the Republic of Belarus;

8.14-2. claims:

the regulations on the commission on medicines also determine its structure;

regulations on independent ethical committee;

Proper pharmaceutical practice;

Proper practice of storage of medicines;

Proper production practice;

the plan of inspection (pharmaceutical inspection) for compliance to proper pharmaceutical practicians in the field of drug circulation;

8.14-3. creates pharmaceutical inspectorate of the Ministry of Health and approves its organizational structure;";

state subitem 8.17 in the following edition:

"8.17. establishes:

the list of the test laboratories accredited in the National accreditation system of the Republic of Belarus for testing of medicines;

procedure and conditions of monitoring procedure of quality of the medicines including made in drugstore before their receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus;

procedure and cases of inspection (pharmaceutical inspection) of industrial production of medicines on compliance to requirements of the Proper production practice;

requirements and procedure for certification of authorized persons of producers of medicines of the Republic of Belarus;

procedure for forming and maintaining register of authorized persons of producers of medicines of the Republic of Belarus;

procedure for forming and maintaining register of pharmaceutical inspectors of the Republic of Belarus;

procedure and conditions of inspection (pharmaceutical inspection) of pharmaceutical production of the revealed low-quality medicine regarding compliance to requirements of Proper pharmaceutical practice and pharmacopoeian Articles of the State pharmacopeia of the Republic of Belarus;

procedure and conditions of performing clinical trials (testing) of medicines, medical products, biomedical cellular products, including procedure for the admission of health, pharmaceutical workers to their carrying out;

procedure and conditions of inspection (pharmaceutical inspection) of clinical trials (testing) of medicines regarding compliance to requirements of Rules of proper clinical practice of the Eurasian Economic Union;

procedure for the organization of system of pharmakonadzor and procedure for inspection (pharmaceutical inspection) regarding compliance of the organization and functioning of system of pharmakonadzor of holders of registration certificates to requirements of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union;

procedure and conditions of informing health and pharmaceutical workers by manufacturer representatives of medicines on the medicines included in the State register of medicines of the Republic of Belarus or in the unified register of the registered medicines of the Eurasian Economic Union;

the procedure and conditions of maintaining the list "A" including medicines which toxicological properties constitute potential danger for health of the person and require special storage conditions;

cases and procedure for retail sale of medicines in venues of the international thematic exhibitions, international sports, and also cultural events;

procedure for retail sale of medicines by the health worker of the state organization of health care or its structural division located in rural settlements and also such health worker during exit medical examinations of the population;

list of the main medicines;

the list of the medicines realized without recipe of the doctor;

procedure for writing out of recipes of the doctor on medicines, including in electronic form, and blank forms of recipes of the doctor on medicines, except for procedure for writing out of recipes of the doctor on medicines and blank forms of recipes of the doctor on medicines for preferential, including free, providing with medicines;

requirements to the documents constituting the registration file;

the criteria shown to trade names of medicines;

procedure for submission by health and pharmaceutical workers of information on the revealed undesirable reactions to medicines;

in coordination with the Ministry of Labour and Social Protection and the Ministry of Finance:

job grades, lists stimulating (except award) and the compensating payments, their sizes (except the allowance for length of service in state-financed organizations) and procedure of such payments for positions of health, pharmaceutical workers, and also the employees occupied in health care and pharmaceutical activities irrespective of departmental subordination of state-financed organizations;

lists of the stimulating and compensating payments, and also the sizes and procedure of these payments to employees of the state-financed organizations subordinated and (or) which are a part of the system of the Ministry of Health and also to employees of the state-financed organizations subordinated to local executive and administrative organs, relating to field of activity of the Ministry of Health;";

state subitem 8.19 in the following edition:

"8.19. will organize and (or) carries out inspection (pharmaceutical inspection) of stages (processes) of drug circulation on compliance to requirements proper pharmaceutical the practician in the field of drug circulation;";

state subitem 8.20 in the following edition:

"8.20. makes the decision:

about suspension of realization and medical application of medicines;

about retirement of medicines, medical products, biomedical cellular products;

about renewal of realization and medical application of medicine;

about prohibition of implementation of the activities of the legal entity connected with industrial production, quality control and realization of medicine in case of identification during inspection (pharmaceutical inspection) of industrial production of medicines of the facts posing threat of damnification of life or to health of the population;";

state subitem 8.21 in the following edition:

"8.21. will organize system of pharmakonadzor;";

in subitem 8.21-1 "collateral" to replace the word with the word "undesirable";

exclude subitem 8.24-1;

in subitem 8.27:

third to state the paragraph in the following edition:

"the conclusions (allowing documents) for import of the unregistered medicines intended for carrying out state registration, use as exhibition samples without the right of their further realization, delivery of health care according to vital testimonies of the specific patient or delivery of health care to the narrow contingent of patients with the proved inefficiency or intolerance of the registered medicines, or with orphan (rare) diseases and (or) zhizneugrozhayushchy diseases, or with serious disabling illness, ensuring early access for patients to new methods of treatment;";

after the paragraph of third to add the subitem with paragraphs of the following content:

"the conclusions (allowing documents) for import of the registered and unregistered medicines intended for carrying out preclinical (not clinical) researches, confirmation of state registration without the right of their further realization, performing clinical trials (testing), the prevention and elimination of effects of emergency situations of natural and technogenic nature, including epidemic diseases, and also imported as foreign free aid;

the registration certificate by results of implementation of state registration (confirmation of state registration) of medicine, state registration of medicines in the simplified procedure or conditional state registration (confirmation of conditional state registration) of medicine;

the document (certificate) confirming compliance of industrial production of medicines to requirements of the Proper production practice and (or) to requirements of Rules of the Proper production practice of the Eurasian Economic Union;

certificate of pharmaceutical product;

permissions to performing clinical trials (testing) of medicines;";

1.3. in the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, No. 156 approved by the resolution of Council of Ministers of the Republic of Belarus of February 17, 2012:

state Item 10.5 in the following edition:

"10.5. Issue of the conclusions (allowing documents) for import to the territory of the Republic of Belarus:

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