For registration and re-registration, as well as for receiving conclusion on the quality of the imported medicinal product, the Applicant (Marketing authorization holder - MAH) needs:
- either a Conclusion on the Recognition of the PIC/S GMP Certificate of compliance of the conditions of manufacturing of medicinal products with GMP requirements;
- or the Certificate of compliance of the conditions of manufacturing of medicinal products with GMP requirements.
The conclusion and the Certificate are issued by the State Service of Ukraine on Medicines and Drugs Control (SMDC) on the basis of the submitted Application and the corresponding procedure.
Since 2011 Ukraine is a member-country of PIC/S (https://www.picscheme.org/), an international instrument for interaction between countries and competent authorities in the field of quality control of medicinal products (national pharmaceutical inspectorates), which collectively provide active and constructive cooperation on compliance with the requirements of the Good Manufacturing Practices (GMP) by inspecting and licensing the manufacturing conditions.
The upgraded version of the Guidelines "Medicinal Products. Good Manufacturing Practice" has come into force in Ukraine since 2016, corresponding to the document "The Rules Governing Medicinal Products in the European Union. Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use".
Therefore, Ukraine puts forward high-level requirements to the manufacturing of medicinal products approved for medical use. As we mentioned above, there are two ways to confirm the compliance of manufacturing of medicinal products with GMP requirements:
- either by recognizing the GMP certificate issued by a competent authority of a PIC/S member-country;
- or by inspecting the manufacturing conditions by Ukrainian inspectorate.
Recognition of the GMP certificate is carried out by the State Service of Ukraine on Medicines and Drugs Control (SMDC) on the basis of the results of examination of the documentation, receipt of the conclusion and does not require any inspection of the manufacturing site. Recognition is only applicable to those manufacturers who already have the GMP certificate issued by a competent authority of the PIC/S member-country (https://www.picscheme.org/en/members). Certificates issued by the WHO or other authorities or organizations that are not members of the PIC/S cannot be objects of recognition. Mexico, Turkey and Iran have become PIC/S members since January 1, 2018.
The procedure for recognition is not an unconditional and requires the preparation and submission of an Application and a package of documentation, passing through procedure of expert evaluation, if necessary, responding to observations, and receiving a conclusion of Recognition. The duration of the GMP certificate recognition procedure is approximately 30-45 working days. For medicinal products intended for treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncological and orphan diseases, as well as medicinal products that are registered under the centralized EMA procedure, medicinal products that have undergone the pre-qualification procedure of the WHO and are included in the list of WHO of pre-qualified medicinal products, duration the procedure for the recognition of the GMP certificate is approximately 7 to 10 working days.
The decision is issued for the validity period of the GMP certificate, which has been recognized, but not more than for the period of validity of the license.
Certification (inspection) of compliance with GMP requirements is also carried out by the State Service of Ukraine on Medicines and Drugs Control (SMDC), but specialized assessment of documentation and inspection can be transferred to the third authorized organizations. The submission of the Application for the issuance of the Certificate involves the preparation and submission of a package of documents, the signing of a contract, the coordination of the program and inspection plan, the payment of expert activities of the competent authority, the conduct of the inspection (usually by two inspectors), the preparation of the report, the issuance of the GMP Compliance Certificate, the settlement of the CAPA.
The duration of the procedure for confirming the compliance of the conditions for the manufacturing of medicinal products with GMP requirements by means of issuing a certificate is approximately 3 to 5 months (including evaluation of the documentation by the SMDC, third authorized organizations, inspection, preparation of the report and the Certificate).
The Ukrainian GMP certificate is issued for a period of 3 years from the date of the inspection.
A preliminary audit (pre-audit) is the service offered by Cratia on the basis of which the MAH will receive the objective assessment of the documentation and the manufacturing site prior to the state inspection, as well as recommendations for preparing the site and personnel for inspection, proposals for the necessary corrective actions.
During the preliminary audit, we will perform:
- in-depth analysis of the Site Master File, including project documentation, SOPs, etc.;
- on-site audit of the manufacturing conditions by the certified staff auditor with excellent knowledge of English;
- analysis and assistance in the preparation of CAPA.
Without a doubt the audit results are strictly confidential information. The conclusion is an official document and is signed by the auditor.