New state registration procedure for medicinal products established.

Belarus: State registration procedure for medicinal products and pharmaceutical substances
adopted by Resolution of the Council of Ministers of 1 April 2015 № 254.

 The following state registration procedure has been established for medicinal products and pharmaceutical substances:
Before a medicinal product is registered by the state, the Centre for Healthcare Examination and Testing takes measures to analyse it against safety and effectiveness requirements as well as quality standards. An applicant may hand in the registration dossier to the Ministry of Public Health for the purpose of state registration of a medicinal product only after obtaining a favourable result from the Centre for Healthcare Examination and Testing.

Moreover, if the state registers a medicinal product:

in several pharmaceutical forms at one time, a certificate of registration is issued for each pharmaceutical form;

produced by pharmaceutical enterprises (or their structural subdivisions) located in different states, each medicinal product produced in each of those states is issued a certificate of registration;

in one pharmaceutical form at one time but in different dosages, one certificate of registration is issued (a new certificate of registration is issued on later state registration of a new dosage).

If violations listed in the Law “On pharmaceutical products” are detected, the Ministry of Public Health can decide to suspend a certificate of registration. A certificate cannot be prolonged for the period of its suspension.

The Ministry of Public Health can terminate a certificate of registration if:

an applicant fails to eliminate circumstances which led to suspension of the certificate;

an applicant refuses to conduct clinical trials of a medicinal product prescribed by the Ministry of Public Health;

an applicant applies to terminate a certificate.

The Resolution is in force as of 21 of May 2015.

Bnt attorneys-at-law have been offering legal advice in Belarus since 2007. Among its clientele are many clients successfully advised by bnt in the sphere of pharmaceutical law. If you have any queries, please do not hesitate to contact our highly skilled and experienced experts.

Source:National legal Internet portal of the Republic of Belarus (NLIP) 03.04.2015, 5/40348

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