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.
The recognition procedure requires a thorough analysis and examination of the relevant documentation package provided by the Applicant, preparation of the Application and completion of the relevant documentation package and submission to the State Service of Ukraine on Medicines and Drugs Control. In the course of the examination of the materials provided, it may become necessary to reply to the expert’s comments. We will make a request and compile an appropriate reply to accomplish Customer’s objective. The duration of the procedure is approximately 45 working days from the date of submission of the Application and obtaining of the list of documents submitted. The decision to recognize a PIC/S Certificate of Conformity on compliance of the manufacturing conditions of the pharmaceutical products with the requirements of GMP is issued for the duration of its validity.