The Ministry of health has changed the application form to make changes to the registration dossier

the Ministry of health of the Russian Federation published a notice on the preparation of a draft regulatory act "on amendments to the application form for amendments to the documents contained in the registration dossier for a registered medicinal product for medical use, approved by the order of the Ministry of health of the Russian Federation dated 21.09.2016 No 727n". The application form will be supplemented with the appropriate fields in order to implement the provisions of Law No. 425-FZ, which provides for the indication in the state register of drugs for further application of a number of information. The document is due to come into force in October 2018.

GMPnews.ru, 22.06.2018, " Ministry of HEALTH CORRECTS FORM

applications for DEPOSIT

CHANGES to the REGISTRATION DOSSIER "

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