Compliance with the requirements of quality and safety of medicines during circulation
Pharmaceutical products that don’t meet the requirements of technical and regulatory documentation as well as regulatory legal acts, or where previously unknown dangerous properties were detected, are often removed and their circulation in the territory of Ukraine is completely prohibited. In this case, it is possible to carry out the procedure of renewing the circulation of pharmaceutical products, provided that the relevant documentation will be made consistent with the current legislation.
We will analyze all approved registration materials in order to identify discrepancies concerning the pharmaceutical product: registration certificate, quality control methods, approved texts of labels and the instruction, and, if necessary, develop and approve necessary changes to the approved materials of the registration dossier, and file these changes in the database of the State Service of Ukraine on Medicines and Drugs Control. In the event of the discovery of discrepancies in quality control methods, we will carry out an alternative examination and control in the independent laboratories. If our Customer disagrees with the claims against the pharmaceutical product, we will carry out arbitration quality control in a different accredited laboratory.