The new Law introduces changes covering all spheres of medicine circulation
The main amendments are:
1. Registration (confirmation of medicine registration)
Medicines will be allowed to be sold and used in Belarus not only after state registration (confirmation of state registration), but also after registration (confirmation of state registration) within the framework of the Eurasian Economic Union.
The national registration procedure continues to apply only for medicines that will be released into circulation exclusively in Belarus.
The new version allows for a conditional state registration (confirmation of registration) procedure for original medicines for medical treatment, preventive care and diagnosis of life-threatening and disabling diseases as well as medical products for treatment of orphan (rare) diseases in the absence of effective methods of medical care.
The conditional registration procedure is established by the Government.
2. Introduction of Good Pharmacy Practices in the sphere of medicine circulation
The new edition lists Good Pharmacy Practices in the field of circulation of medicines and establishes their distribution at all stages (processes) of medicine circulation. The list includes both Good Pharmacy Practices approved by the Belarusian Ministry of Healthcare and Practices approved at the Eurasian Economic Union level.
3. Grounds for suspension and termination of a medicine’s registration certificate
New grounds for suspension of a medicine’s registration certificate for up to 6 months are: refusal by the holder of a medicine’s registration certificate to:
• perform obligations related to pharmaceutical supervision;
• carry out clinical trials (tests) assigned by the Ministry of Health;
• inspect industrial manufacture of a medicine against compliance with the requirements of Good Manufacturing
Practice when a medicine is recognized as one of poor quality.
At the same time, the list of grounds excludes disclosure of the fact of exceeding the stated price of the medicine in the contract for supply.
The Law states that a medicine’s registration certificate must be terminated if a court finds a violation of the rights of the intellectual property rights holder.
The Law comes into legal force from 20 November 2020.
Source: National legal internet portal of the Republic of Belarus (NLIP) 19.05.2020, 2/2732