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