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Registration of pharmaceutical products

Registration/re-registration/applying for variations in registration documents of pharmaceutical products, medical devices and food supplements in shortest period:

  • receiving of original documents from the manufacturer;
  • translation of documents into Ukrainian or Russian, notarized translation of the documents;
  • preparation of documents in conformity with requirements of Ukrainian registration authorities;
  • submission of application to the State Expert Centre of Ukraine for registration of medicines and submission of corresponding documentation;
  • informing of a manufacturer about registration of a medicine in Ukraine;
  • coordination of registration process, including dealing with current issues with regulatory authorities;
  • receiving of a certificate of registration;
  • registration of amendments that were introduced by companies during the validity term of the certificate of registration (MA);
  • re-registration of medicines (every 5 years).

Recognition and/or Receipt of Conclusions confirming the GMP compliance of a manufacturer, receipt of Import license