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Additional drug trials concerning confirmation the quality of medicinal products will be cancelled during theirs reregistration.
The relevant order dated on July 7,2014 #470 «On amendments to the Order of examination of registration documents on medicinal products submitted to the state registration (reregistration) as well as examination of documents on amendments to the registration documents during termination of registering certificate was adopted by Ministry of Health of Ukraine. This order hasn’t come into force.
According to the currently edition of the Order on examinations of registration documents additional examination are not held during reregistration of medicinal product.
In the case of termination of registration certificate specification and drug quality control methods were not changed and applicant not entered and not enters changes to the registering dossier into the part concerning specification and drug quality control methods. In other words additional conditions are specified.
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