Key changes in Belarusian legislation on pharmaceutics and healthcare (July – September 2020)

Medical services

On the list of procedures (surveys, manipulations) classified as operations/services licensable as medical activities

Resolution of the Council of Ministers of the Republic of Belarus dated 25.05.2020 No. 307

The document has gone into effect 28.08.2020.
 

Summary

Some spa services indicated in STB 2412-2015 “Personal services. Spa services. Defined terms” and STB 2438-2016 “Personal services. Spa services. General requirements” are classified as medical services.

Accordingly, in order to render spa services licensable as medical activities, corporate entities and individual entrepreneurs must obtain a license.

Medical services

On amending Resolution of the Ministry of Finance of the Republic of Belarus dated March 22, 2019 No. 11

Resolution of the Ministry of Finance of the Republic of Belarus dated 06.08.2020 No. 32

The document has gone into effect 22.08.2020.

Summary

Documents required to compile an insurance event report must necessarily specify, particularly:

• number (series) and duration of the voluntary insurance agreement;
• data on the insured party that availed of medical aid (full name, including patronymic (if any), date of birth, identification number or (in default thereof) number of personal ID).

Medical equipment

On amending Resolution of the Ministry of Public Health of the Republic of Belarus от 03.10.2006 No. 78

Resolution of the Ministry of Public Health of the Republic of Belarus dated 26.02.2020 No. 11

The document has gone into effect 03.07.2020.

Summary 

Significant modifications of organisational procedures pertaining to maintenance and repair of medical equipment.

The Resolution has established a list of standard scheduled tasks in the course of maintenance of medical equipment and a list of operations pertaining to planned repairs of medical equipment.

Pharmaceutics, medical products and medical equipment

On state registration of medical products, medicinal drugs and pharmaceutical substances 

Resolution of the Council of Ministers of the Republic of Belarus dated 19.05.2020 No. 298

The document has gone into effect 23.08.2020.

Summary

Alterations made to:

• Regulation on state registration (re-registration) of medical products and medical equipment;

Severe alterations were made, in particular, to the procedures on amending registration dossiers on medical products and medical equipment earlier registered in the Republic of Belarus.

• Regulation on procedures and conditions of state registration (endorsement of state registration) medicinal agents and pharmaceutical substances, alteration of registration dossiers;

Major changes pertain to procedures of alteration of registration dossiers.

• a unified list of administrative procedures carried out by state authorities and other entities with respect to legal entities and individual entrepreneurs.

For the purposes of state registration (re-registration) of a medicinal agent, design of primary and secondary package (or interim package – if any) may include marking not only in the Belarusian or Russian language, but in a foreign language as well, together with a sticker in the Belarusian or Russian language (for medicinal agents of foreign manufacture).

Pharmaceutics

On amending Decision of Council of Eurasian Economic Commission dated 03.11.2016 No. 93

Decision of Council of Eurasian Economic Commission dated 04.09.2020 No. 66

The document has gone into effect 11.10.2020.

Summary

Mutual recognition has been established, for the period from 2021 to 2025, for: 

• national GMP certificates of Eurasian Economic Union member states;
• EEU GMP certificates, for the purposes of amending registration dossiers and extending national registration certificates for pharmaceuticals manufactured in the EAEU;
• for the purposes of national registration of EEU GMP certificates for pharmaceuticals manufactured in third countries.

Pharmaceutics

On issuing pharmaceutical product certificates 
Resolution of the Council of Ministers of the Republic of Belarus dated 18.09.2020 No. 545

The document shall come into effect 20.11.2020.

Summary

The Resolution endorsed the Regulation on the procedures of issuance of pharmaceutical product certificates for the purposes of international sales. 

The Regulation specifies the procedures of issuance of pharmaceutical product certificates for the purposes of international sales in accordance with WHO recommendations, with respect to commercial production of pharmaceuticals for export.