Turkish Medicines and Medical Devices Agency (“TITCK”) has announced on February 3, 2021, the extension of additional measures in consequence of COVID-19 restrictions, to be applied regarding GMP (Good Manufacturing Practices) inspections that take place abroad and certification processes. Previously, TITCK had taken additional measures regarding mentioned processes on June 10, 2020, to prevent setbacks regarding production and provision processes of medicinal products for human use and continuance of market supply. With this respect, GMP certificates had been extended until June 31, 2021, concerning products with certificates to expire and require on-site inspection, provided that the certificate scope was unchanged and with exceptions for risk-based inspections.
As per TITCK’s recent announcement, since GMP inspections still cannot be carried out abroad due to the ongoing precautions and restrictions related to the COVID-19 pandemic, the validity period of the GMP certificates, whose validity period was extended until June 31, 2021, was once more extended until December 31, 2021. this extension will be applied to relevant actors without the requirement for importing companies to make an application in this regard. The validity period of the GMP certificates of the products for which a risk-based inspection application was made before the GMP certificate has expired and where an on-site inspection decision was made by TITCK, and for the products with a GMP certificate previously issued by TITCK through an application for on-file inspection are also extended.
However, in case the product, production line, building, etc. have been changed, a new application is required to be submitted pursuant to the Guide on Applications Regarding GMP Inspections of Abroad Manufacturing Sites ("Guide"). In this respect, it has been stated that the existing GMP certificates for which no evaluation has been made and there is no on-site inspection decision are out of the scope of this extension. Therefore, for products with GMP certificate except for the above-mentioned cases, applications should be made within the scope of the Guide before the certificate expires.
Besides, two different methods have been introduced for the applications to be made for facilities previously inspected by TITCK and for the facilities that have not been previously inspected by TITCK, to avoid confusion.
To reach details regarding TITCK’s previous announcement on this matter:
Simge Kılıç, Nihan Ünal