Documents required for registration of the Products of Medicinal Purposes (PMP)
Enumerated list of the documents and materials, submitted for registration.
Application in the established format from the manufacturer or its representative (supplier, importer, etc.). If applicant is not PMP manufacturer itself, then document that confirms his credentials from the manufacturer's side is also required.
Digital version of the PMPs that are submitted for the registration, with catalogue numbers (in the original language and in Ukrainian).
Catalogues, presentations of the PMPs.
Exploitation guide or instruction, technical passport.
international documents, which confirm correspondance of PMPs with the requirements of the national or international normative documents and describe manufacturing conditions (if available).
Correspondance certificate for the PMP, received in corresponance with the current Ukrainian legislation (if available).
Information concerning standards or normative basises which PMP is based upon (if available).
Conclusions of the State Metrological Attestation (for the measuring devices only).
Protocols of the tests concerning quality, safety and effectiveness of the PMP (if available).
Label or product mark-up samples.
Valid documents which confirm manufacturer's registration in the origin country.
Copy of the Applicant's state registration if Applicant performs business activity in Ukraine.
Important! All documents are submitted in 2 copies with the Ukrainian translation, in the original form or notarially certified or in the form of copies sealed by the Applicant if document originals are also provided. Documents will not be returned to the Applicant after the expertise.