of October 6, 2025 No. 138
About approval of Proper pharmaceutical practice
Based on paragraph two of article 7 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" the Ministry of Health of the Republic of Belarus DECIDES: No. 161-Z
1. Approve Proper pharmaceutical practice it (is applied).
2. Recognize invalid resolutions of the Ministry of Health of the Republic of Belarus according to appendix.
3. This resolution becomes effective after its official publication.
Minister
A. V. Hodzhayev
to the Resolution of the Ministry of Health of the Republic of Belarus of October 6, 2025 No. 138
List of invalid resolutions of the Ministry of Health of the Republic of Belarus
1. The resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120 "About approval of Proper pharmaceutical practice".
2. Item 2 of the resolution of the Ministry of Health of the Republic of Belarus of October 31, 2007 No. 99 "About approval of the Instruction about procedure for writing out of the recipe of the doctor and creation of electronic recipes of the doctor".
3. Item 1 of the resolution of the Ministry of Health of the Republic of Belarus of October 31, 2008 No. 181 "About modification and amendments in resolutions of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120 and of October 31, 2007 No. 99".
4. The resolution of the Ministry of Health of the Republic of Belarus of February 28, 2012 No. 10 "About modification of the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
5. The resolution of the Ministry of Health of the Republic of Belarus of March 21, 2014 No. 17 "About entering of amendment into the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
6. Item 1 of the resolution of the Ministry of Health of the Republic of Belarus of September 9, 2014 No. 66 "About modification and amendments in resolutions of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120 and of October 31, 2007 No. 99".
7. The resolution of the Ministry of Health of the Republic of Belarus of May 20, 2015 No. 73 "About modification and amendments in the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
8. The resolution of the Ministry of Health of the Republic of Belarus of February 4, 2016 No. 9 "About introduction of amendments to the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
9. The resolution of the Ministry of Health of the Republic of Belarus of October 23, 2020 No. 86 "About change of the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
10. The resolution of the Ministry of Health of the Republic of Belarus of February 23, 2021 No. 14 "About change of the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
11. The resolution of the Ministry of Health of the Republic of Belarus of January 20, 2023 No. 11 "About change of the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
12. The resolution of the Ministry of Health of the Republic of Belarus of May 26, 2023 No. 96 "About change of the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
13. The resolution of the Ministry of Health of the Republic of Belarus of June 14, 2023 No. 103 "About change of the resolution of the Ministry of Health of the Republic of Belarus of December 27, 2006 No. 120".
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of October 6, 2025 No. 138
1. This Proper pharmaceutical practice establishes rules on pharmaceutical production, quality control, control of expiration dates, packaging and marking, storage conditions, pharmaceutical consultation, realization, leave of medicines, including requirements to rooms, the equipment and classification of drugstores by categories.
Requirements of this Proper pharmaceutical practice extend to the legal entities and individual entrepreneurs having the license for implementation of the pharmaceutical activities, and also for the legal entities having license for activities, connected with drug trafficking, psychotropic substances and their precursors (further – legal entities and individual entrepreneurs).
Workers of drugstore observe requirements of this Proper pharmaceutical practice according to the functions which are carried out by them.
2. For the purposes of this Proper pharmaceutical practice terms and their determinations in the values established by the Law of the Republic of Belarus "About drug circulation" and also the following terms and their determinations are used:
other goods of pharmaceutical assortment – means for disinfection and (or) disinsections, repellents, objects and personal hygiene means, condoms, inserts antinoise, ware for the medical purposes, the objects and means intended for patient care, newborns and children, individual protection equipment,-point optics and conditioning agents behind it, accessories for points and contact lenses, mineral waters, drinking water, tea, products of special clinical, baby, specialized and dietary nutrition, sweeteners, dietary supplements to food, juice of small amount (to 250 ml), perfumery and cosmetics, and also the medical and sanitary and educational audio-, video and printing editions intended for promotion of healthy lifestyle, thematic souvenirs, products from polymeric and other materials for packaging;
responsible self-treatment – independent acceptance by the consumer (patient) of medicines which have the proved safety, efficiency and quality are applied according to indications and in the doses provided by instructions on medical application (leaves inserts) taking into account possible interaction with other medicines;
the consumer – person who addressed the pharmaceutical worker is direct in drugstore or by phone;
rational use of medicines – medical application of medicines the consumer (patient) for the purpose of treatment, medical prevention of diseases of the person or recovery of physiological functions according to clinical need for the doses meeting individual requirements throughout necessary period of time with the smallest costs;
the quality manual – the document containing the scheme and the description of organizational structure of the legal entity or individual entrepreneur, the description of policy and the purposes of pharmaceutical activities for pharmaceutical production, retail sale (leave) of medicines, the description of system of quality assurance of medicines, works and services of pharmaceutical activities including pharmaceutical consultation of the population and health workers concerning medicines, resources, qualification and continuous training of pharmaceutical workers and other personnel;
self-inspection – actions for assessment of conformity of the works and services connected with pharmaceutical production and (or) realization, leave of medicines, to requirements of this Proper pharmaceutical practice and other acts of the legislation regulating implementation of pharmaceutical activities;
standard operational procedures (further – SOP) – the documents of system of quality assurance containing the detailed description of stages of the procedure (method or process), including processes of acceptance, storage and realization of medicines, medical products, other goods of pharmaceutical assortment, and providing uniformity of certain functions;
technological instructions (further – TI) – the documents of system of quality assurance containing instructions of the regulating nature for all stages (stages) of engineering procedures on pharmaceutical production of medicines, including the sterile and aseptic made medicines for each dosage form, and also intra pharmaceutical procurement and packing on the health cares which are often met in recipes of the doctor and (or) requirements (requests) of the organizations or their structural divisions (further if other is not established, – the requirement (request) of copy-book for each name and the dosage, including packing and packaging of medicines, control of quality of medicines, receipt of water cleared and (or) waters for injections and other processes;
pharmaceutical consultation of health workers – provision by pharmaceutical workers of drugstore of the reliable and objective information to health workers concerning the medicines which are available and (or) temporarily absent in drugstore including concerning generic and therapeutic replacement, and also concerning the statement of recipes of the doctor on medicines for the purpose of assistance to rational use of medicines;
pharmaceutical consultation of the population – provision by pharmaceutical workers of drugstore of the reliable and objective information to the consumer in available and clear form of properties and the correct medical application of medicines for the purpose of satisfaction of individual need of the patient for medicines of proper quality for preserving health of the person, assistance to rational use of medicines in case of respect for the principles of responsible self-treatment, professional ethics and confidentiality, and also promotion of healthy lifestyle;
shtanglas – glass with the ground-in stopper or the faience container with lid intended for storage of the pharmaceutical substances, excipients and medicinal vegetable raw materials used for pharmaceutical production of medicines.
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