Additional Measures for the GMP Inspections and Certification Process by Turkish Medicines and Medical Devices Agency15 June, 2020
Turkish Medicines and Medical Devices Agency (“TITCK”) has announced additional measures to be applied regarding GMP (Good Manufacturing Practices) inspections that take place abroad and certification processes. Additional measures have been taken due to COVID-19 under the TITCK’s decision numbered E.1466 dated June 10, 2020 to prevent setbacks regarding production and provision processes of medicinal products for human use and continuance of market supply.
As a result of the COVİD-19 pandemic, on-site GMP inspections made abroad had been suspended, however, on-file and risk-based inspections were continued to be made pursuant to the Guide on Applications Regarding GMP Inspections of Abroad Manufacturing Sites (“Guide”). As per the announcement, importer companies’ obligations arising from the applicable legislation are still binding, however following measures will apply to GMP inspections abroad and certification processes until the restrictions with respect to the pandemic end:
Regarding products with certificates to expire and require on-site inspection; GMP certificates will be valid until June 31, 2021 provided that the certificate scope is unchanged. However, in case the product, production line, building, etc. has been changed, a new application is required to be submitted pursuant to the Guide. Regarding facilities that have been previously inspected, a new application is required to be submitted pursuant to Article B of the Guide, whereas for facilities that have not been previously inspected and provided that the high priority products have been inspected by a Pharmaceutical Inspection Co-operation Scheme (PIC/S) member authority, if such products do not meet the criteria determined under Article B of the Guide an exceptional on-file inspection will be made (TİTCK would be able to make an inspection later).
In addition, regarding risk-based inspections, inspection application deadlines have been extended by three months. Importer companies that have difficulties regarding receiving documents from the place of production will be able to submit a commitment letter to deliver such documents when received through the Electronic Document Management System (EBYS). Lastly, regarding applications for certificate extension under the scope of Article B of the Guide, provided that the product has been inspected under the name of another firm and a risk-based inspection application has not been submitted for such product, a certificate extension application can be submitted pursuant to Article C (risk-based inspection) of the Guide.