Belarus

The Republic of Belarus is one of the largest post-Soviet countries with a population of about 9.5 million people, and it is a member of the Eurasian Economic Union (EAEU) along with Russia, Kazakhstan, Armenia and Kyrgyzstan. Membership of Belarus in the EAEU significantly influences the regulatory policy of the state: there is a choice between the “national” and “centralized” registration procedure for medicinal products and medical devices at present, while special food products (dietary supplements, baby food, sports nutrition, etc.) and cosmetic products undergo the procedure in accordance with the relevant Technical Regulations of the EAEU only.

The official languages of Belarus are Belarusian and Russian. Their status is regulated by the Constitution and applicable laws. 

The healthcare system is financed from the state budget by more than 90%, the Constitution guarantees providing patients with free medical care in public health care institutions, and there is the state system for ensuring access to medicinal products.

Belarus is characterized by strong state support and protection of the national manufacturer (import substitution policy), which should be definitely taken into account when deciding to market medicinal products and medical devices that have equivalents produced by national manufacturers. Nevertheless, the imported pharmaceutical products share in the Belarusian market is approximately 75%. State registration of medicines is allowed under national and EAEU procedures. 

The market of medical devices is also formed mainly by exports, with the share of about 87%. Import and sale of medical devices and medical equipment in Kazakhstan are allowed after state registration. Regulatory legislation is being actively developed through gradual integration into the EAEU. State registration of medical devices is allowed under national and EAEU procedures. 

Special food products and cosmetic products are subject to market authorization (registration or declaration) under the “centralized” procedure according to the Technical Regulations of the EAEU.

 

Competent authorities:

The Ministry of Health of the Republic of Belarus.
The central executive authority implementing the state health care policy is
Web-site: http://minzdrav.gov.by/ 

Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care” of the Ministry of Health
Expert evaluation of the registration materials for medicinal products and medical devices, pharmacovigilance
Web-site: http://www.rceth.by/ 

 

Main legislative acts:

  1. Law of the Republic of Belarus “On Medicines”;
  2. The Law of the Republic of Belarus “On Healthcare”;
  3. Decree of the President of the Republic of Belarus No. 499 dated December 31, 2019 “On Circulation of Medicines”;
  4. Resolution of the Council of Ministers of the Republic of Belarus No. 254 “On State Registration (Confirmation of State Registration) of Medicinal Products and Pharmaceutical Substances and Introduction of Amendments and Additions to Resolution of the Council of Ministers of the Republic of Belarus No. 1269 of September 2, 2008” (together with “Regulation on the Procedure for Issuance of Registration Certificate for a Medicinal Products and Pharmaceutical Substances”, “Regulation on the Structure, Procedure for Formation and Maintenance of the State Register of Medicinal Products of the Republic of Belarus”);
  5. Resolution of the Ministry of Health of the Republic of Belarus No. 52 dated May 08, 2009 “On Requirements to Documents Submitted for State Registration (Confirmation of State Registration) of Medicines, State Registration of Pharmaceutical Substances, Amendments to the Registration File for Medicines, Pharmaceutical Substances Previously Registered in the Republic of Belarus”;
  6. Decision of the Ministry of Health of the Republic of Belarus of 17.04.2015 No. 48 “On approval of the Instruction on the procedure of presenting information on detected undesirable reactions to medicines and recognition of some resolutions of the Ministry of Health of the Republic of Belarus as invalid”;
  7. Decision of the Council of Ministers of the Republic of Belarus No. 1269 of 02.09.2008 “On approval of the Regulation on state registration (re-registration) of medical devices and medical equipment”;
  8. Resolution of the Ministry of Health of the Republic of Belarus No. 41 of April 15, 2009 “On requirements to the documents submitted for state registration (re-registration) of medical devices and medical equipment”;
  9. Order of the Ministry of Health of the Republic of Belarus from 16.12.2014 № 1324 “On approval of classifications of medical devices”;
  10. Resolution of the Ministry of Health of the Republic of Belarus of 14.05.2015 No. 72 “On Approval of the Instruction on Cases and Procedure of Inspection of Industrial Production of Medicinal Products (Recognized as Poor Quality Medicinal Products) for Compliance with the Requirements of Good Manufacturing Practice”;
  11. Order of the Ministry of Health of the Republic of Belarus “On approval of the Instruction on the procedure for organizing the inspection of industrial production of medical devices and medical equipment”;
  12. Decision No. 216 of the Ministry of Health of the Republic of Belarus of 18 December 2008 entitled “On some issues related to clinical trials of medical devices and medical equipment”;
  13. Order of the Ministry of Health of the Republic of Belarus of 10.03.2015 No. 235 “On approval of the Instruction on sterility control of each batch (series) or part of the batch (series) of registered medical devices before their entering into realization and on introduction of addition to the Order of the Ministry of Health of the Republic of Belarus of February 25, 2011 No. 195”;
  14. Resolution of the Ministry of Health of the Republic of Belarus of June 19, 2017, No. 64 “On Approval of the Technical Code of established practice”, TKP 030-2017 (33050).

 

Cratia provides professional services of state registration of medical (healthcare) products in Belarus. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:

Ready to start cooperation or want to learn more? Contact us: 

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(name, formulation, dose and route(s) of administration, date of therapy start)