1. Normative legal acts on the quality control of medicines (current editions):

Law of the Republic of Belarus dated June 20, 2006 No. 161-З "On Medicines";

Decree of the President of the Republic of Belarus of October 16, 2009 No. 510 "On improving control (supervisory) activities in the Republic of Belarus";

Decree of the President of the Republic of Belarus of December 31, 2019 No. 499 "On the Circulation of Medicines";

Resolution of the Council of Ministers of the Republic of Belarus dated April 1, 2020 No. 191 "On measures to implement the Decree of the President of the Republic of Belarus No. 499 dated December 31, 2019";

Resolution of the Council of Ministers of the Republic of Belarus dated November 30, 2012 No. 1105 "On approval of the list of technical (technological, verification) measures";

Resolution of the Council of Ministers of the Republic of Belarus dated December 22, 2009 No. 1677 “On approval of the Regulation on the procedure for storage, transportation, withdrawal from circulation, return to the manufacturer or supplier, destruction of medicines”;

Resolution of the Ministry of Health of the Republic of Belarus of March 1, 2010 No. 20 “On Approval of the Instruction on the Procedure and Conditions for Conducting Quality Control of Medicines Registered in the Republic of Belarus, Before Going on Sale, as well as Medicinal Products in Circulation on the Territory of the Republic of Belarus, amendments and additions to the order of the Ministry of Health of the Republic of Belarus dated January 15, 2007 No. 6 and invalidation of the order of the Ministry of Health of the Republic of Belarus. Belarus of June 24, 2002 No. 37 and item 14 of the Resolution of the Ministry of Health of the Republic of Belarus of December 22, 2006 No. 117 ";

Resolution of the Ministry of Health of the Republic of Belarus
dated December 27, 2006 No. 120 "On the approval of good pharmacy practice";

Resolution of the Ministry of Health of the Republic of Belarus
dated April 17, 2015 No. 49 "On approval of the Instruction on the procedure and conditions for quality control of medicines produced in pharmacies";

State Pharmacopoeia of the Republic of Belarus.


2. Normative legal acts, technical normative legal acts:

Decree of the President of the Republic of Belarus of September 1, 2010 N 450 "On licensing certain types of activities";

Decree of the President of the Republic of Belarus of October 16, 2009 N 510 "On improving control (supervisory) activities in the Republic of Belarus";

Law of the Republic of Belarus of July 20, 2006 N 161-З "On Medicines";

Resolution of the Council of Ministers of the Republic of Belarus of December 22, 2009 N 1677 "On approval of the Regulation on the procedure for storage, transportation, withdrawal from circulation, return to the manufacturer or supplier, destruction of medicines";

Order of the Ministry of Health of the Republic of Belarus dated January 15, 2007 No. 6 "On approval of good wholesale practice";

Resolution of the Ministry of Health of the Republic of Belarus of November 17, 2009 N 123 "On approval of the Instruction on the procedure for retail sale of medicines by a medical worker of a state healthcare organization or its structural unit located in rural settlements at the place of residence." no pharmacies ”;

Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 N 49 "On approval of the Instruction on the procedure and conditions for quality control of medicines produced in pharmacies";

Resolution of the Ministry of Health of the Republic of Belarus of July 16, 2007 N 65 "On approval of the list of essential medicines";

Resolution of the Ministry of Health of the Republic of Belarus dated December 10, 2018; N 92 "On the establishment of the list of Belarusian (Russian) medicines, mandatory for availability in pharmacies";

Resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 N 120 "On approval of the Rules of pharmaceutical practice";

Resolution of the Ministry of Health of the Republic of Belarus of April 10, 2019 N 27 "On establishing a list of medicines dispensed without a doctor's prescription";

Resolution of the Ministry of Health of the Republic of Belarus of June 19, 2017 N 64 "On approval of the Technical Code of the established practice";

Order of the Ministry of Health of the Republic of Belarus of December 2, 2013 N 114 "Sanitary and epidemiological requirements for the transportation, storage and use of immunobiological drugs, preventive vaccinations, identification, registration and investigation of adverse reactions after preventive vaccinations";

Resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 N 51 "On approval of the Instruction on cases and procedure for checking pharmaceutical production of medicines for compliance with the requirements of Good Pharmaceutical Practice and the requirements of the state." Pharmacopoeia of the Republic of Belarus ";

Resolution of the Ministry of Health of the Republic of Belarus dated September 22, 2008 N 144 "On approval of the norms of natural loss of medicines, cotton wool, ethyl alcohol in pharmacies, pharmacy warehouses, analytical (testing) laboratories, government agencies." provision of medical (pharmaceutical) education, as well as Instructions on the application of the norms of natural loss of medicines, cotton wool, ethyl alcohol in pharmacies, pharmacy warehouses, control and analytical (testing) laboratories, government bodies carrying out medical (pharmaceutical) education ";

Resolution of the Ministry of Internal Affairs of the Republic of Belarus, Ministry of Health of the Republic of Belarus of April 4, 2005 N 105/9 "On approval of the Instruction on the requirements for technical reinforcement and equipping with technical security systems of premises." intended for the storage of narcotic drugs and psychotropic substances ”.


Address: Republic of Belarus, 220034, Minsk, per. Bronevoy, 10a
Reception: +375 (17) 271-25-75
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