Changes to the list of medicines for registration in Ukraine
Conclusion or Certificate of Conformity is the official document certifying compliance of the manufacturing conditions of pharmaceutical products with the requirements of good manufacturing practice (GMP), that’s why the List of pharmaceutical products registered or planned for registration in Ukraine is an integral part hereof. The change procedure is carried out in connection with this List. In our experience, the change procedure can be repeated depending on the materials being refined, for example, if the registration certificate of a pharmaceutical product has been obtained already, its number must be entered in the List and it is necessary to obtain an updated List. State Service of Ukraine on Medicines and Drugs Control issues an updated List to the Conclusion or Certificate of Conformity pursuant to the documentation provided by the Applicant or by his/her authorized representative.
In order to carry out the procedure we will make a request, an extensive analysis of the submitted documents and harmonize them with the current legislation of Ukraine. Filing the Application and submitting the required documentation package, as well as the receipt of the List of documents submitted, will take approximately 3-5 working days, after which preliminary and specialized examination of the submitted materials will be carried out. In the event of a positive decision of the State Service of Ukraine on Medicines and Drugs Control concerning this procedure, and only after the approval of the updated List of the pharmaceutical products registered or planned for registration in Ukraine, we will be able to obtain a new updated version. It is worth mentioning that a new list can be obtained only in exchange for the previous version of the list. That’s why we will require the original copy of the previous List for submission to the State Service of Ukraine on Medicines and Drugs Control.