Medicines registration procedure simplified and rules on pharmaceutical activity changed in 2020.
Simplified medicines registration procedure
The medicines registration procedure involves a set of preliminary technical work (expert examinations, inspection of industrial manufacturing, tests and other procedures) before applying for state registration.
The new rules lay down a period of 30 working days (the general period is not more than 180 calendar days) for carrying out all preliminary technical work when a simplified registration procedure applies. At the same time, total costs for state registration of medicines (excluding VAT) must not exceed 120 basic values (approx. 1 400 EUR).
The simplified procedure covers medicines registered in Australia, Austria, the USA, Canada, Switzerland, Japan, the United Kingdom, Germany, Denmark, the Netherlands, Sweden, Spain and Portugal. The simplified procedure also applies to medicines registered in the European Union under the centralized procedure for use on the territory of the listed countries, as well as medicines against tuberculosis, hepatitis C, HIV infections and vaccines that have passed the World Health Organization re-qualification programme.
Simplified registration does not apply to homeopathic medicines, medicines based on herbal substances, vitamin-mineral complexes and pharmaceutical substances.
A more detailed procedure for simplified registration will be set by the Belarus Council of Ministers within three months.
In testing the quality of a foreign-made medicine, the new rules require production of copies of the sale and purchase agreement with the manufacturer, the holder of the medicine’s state registration certificate (or their authorized distributor) attaching the agreement between them to confirm the status of the distributor.
Good Pharmacy Practices
From 2 January 2020 the EAEU’s Good Pharmacy Practices, including Good Distribution Practice (GDP), Good Pharmacy Practice (GPhP) and others are binding on manufacturers, wholesale distributors and pharmacies. In the future, a procedure will be laid down for inspecting compliance with these rules via issuance of an opinion.
The new rules foresee establishment of a new state institution called “Public pharmaceutical supervision in the sphere of distribution of medicines” (abbreviated to “Gospharmnadzor”) before 1 May 2020. The institution will be subordinated to the Belarusian Ministry of Healthcare.
Source: National legal internet portal of the Republic of Belarus (NLIP) 31.12.2019, 1/18766