On March 23, 2012 the Ministry of Healthcare of Ukraine submitted the draft amendments to the resolution of the Cabinet of Ministers of Ukraine No. 73 dd. 15.01.2012 and No. 376 dd. 26.05.2005 for public discussion. The amendments apply to the registration procedure for medicinal products and medical immunobiological preparations, namely as follows:
- State registration of medical immunobiological preparations will be confirmed by a bill of state registration of a medicinal product (medical immunobiological preparation) instead of a certificate, as it is now;
- The right to apply for state registration will be granted to an individual or a legal entity having the resources to implement pharmacovigilance in Ukraine;
- The Ministry of Healthcare will consider an application for registration and after that refer it to the appropriate expert establishment;
- In addition to an application for state registration it will be necessary to submit a copy of document confirming the compliance of manufacturing conditions of a medicinal product with the Good Manufacturing Practices approved in Ukraine;
- The Ministry of Healthcare of Ukraine is entitled to decide on the prohibition of turnover of a medicinal product by terminating its registration certificate, if the medicinal product has not been in the turnover for 3 years from the date of its registration;
- Vaccines and toxoids shall be re-registered in accordance with the re-registration procedure for medicinal products based on the data on their effectiveness and safety, which were obtained from their medical use.
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