Ministry of health of Ukraine (MoH) presented to public Draft Resolution of CMU ‘On making amendments to the procedure of registration (re-registration) of medicinal products (hereinafter – Draft Resolution) which implements provisions to the law of Ukraine from 12.08.2014 No 1637-VII ‘On making amendments to the Law of Ukraine ‘On medicinal products’ to the state procedure of registration of medicinal products (order of CMU on May 26, 2005, No376).
As we have previously reported from 5.10.2014 the decision about registration or refusal in registration of medicinal product aimed at tuberculosis, HIV/AIDS, viral hepatitis, oncological diseases and rare (orphan) diseases treatment registered by authority body of the USA, Switzerland, Japan, Australia, Canada or EU as medicinal product must be taken within 7 days.
In addition Draft Resolution provides simplification of state registration procedure of medicinal products which have been registered by European Medicines Agency. In the case of adoption of Draft Resolution concerning such medicinal products the inspection and additional researches will not be held.
The reasonable ground of state registration of such medicinal products should be submission with the application of registering materials (registering dossier) and registering dossier report evaluation approved by European Medicines Agency.
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