CERTIFICATION

Amendments 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.

Expanding 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.

Certification of Pharmaceutical Products Manufacturing

Certificate of conformity of the manufacturing conditions issued by the authorized body of the PIC/S member state is the official document certifying compliance of the manufacturing conditions of the pharmaceutical products with the requirements of good manufacturing practice (GMP). Ukraine has joined this international authorized body of cooperation between countries for the quality control of pharmaceutical products in 2011. Currently they already ensure productive cooperation regarding compliance with the requirements of good manufacturing practice (GMP), holding inspections and licensing manufacturing at a high professional level, and imposing high demands on the production of pharmaceutical products authorized for medical use in Ukraine. State Service of Ukraine on Medicines and Drugs Control issues a Certificate of Conformity that confirms compliance of the manufacturing conditions of pharmaceutical products with the requirements of good manufacturing practice (GMP).

Recognition of EC Certificate of Conformity of GMP

For the registration, reregistration of a pharmaceutical product or for obtaining a Conclusion on quality of the product, the Applicant or importer must obtain a Recognition of PIC/S Certificate of Conformity on compliance of the manufacturing conditions of the pharmaceutical products with the requirements of GMP in Ukraine with the relevant list of products planned for registration or registered in Ukraine. Thanks to PIC/S, obstacles to international trade of pharmaceutical products have been eliminated through mutual recognition of the results of pharmaceutical production inspection carried out by national regulatory authorities. Recognition of the PIC/S Certificate is carried out and issued by the State Service of Ukraine on Medicines and Drugs Control pursuant to the results of the examination of the materials provided and doesn’t require direct inspection of the manufacturing site. Certificates issued by organizations other than members of PIC/S can’t be recognized.

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