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11/09/2021 https://www.esin.av.tr/wp-content/themes/esin/images/esin.jpg

TİTCK Publishes Updated GMP Certificate Forms

Legal Alerts
Healthcare
General

Recent Development

The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently published the latest version of the Good Manufacturing Practice (GMP) Certificates, updated in line with Turkey’s Pharmaceutical Inspection Co-operation Scheme (“PIC/S”) membership.

What Does the Announcement Say?

The TİTCK, following its membership in the PIC/S early this year, has been harmonizing the certification process in line with PIC/S standards. In this scope, the TİTCK recently updated the GMP Certificate forms in line with Turkey’s PIC/S membership and announced that the production facilities for medicinal products for human use operating in Turkey must use the forms available on the TİTCK’s website when applying to the TİTCK for GMP certificates and other export certificates.

Companies must apply by selecting the document type “GMP Certificate” or “Manufacturing License”. The updated forms are available online here.

Conclusion

The TİTCK continues to provide guidance for manufacturers of medicinal products for human use. Companies must carefully follow the TİTCK’s announcements and use the forms provided on the TİTCK’s website for their applications.