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

TİTCK Publishes Guidelines for Renewal of Manufacturing Site Permits

Legal Alerts
Healthcare
General

Recent Developments

The Turkish Medicines and Medical Devices Agency (“TİTCK”) published the Guidelines for the Renewal of Manufacturing Site Permits on July 19, 2019 (“Guidelines”). The Guidelines aim to provide guidance for companies regarding their applications to the TİTCK for the renewal of manufacturing site permits.

What’s New?

In 2017, the TİTCK started to issue manufacturing site permits under the Regulation on the Manufacturing Sites of Medicinal Products in the same format as the health authorities in the European Economic Area in 2017. In this regard, the TİTCK developed a module in the Electronic Process Management (tr. ESY) in 2019 to issue new manufacturing site permits.

Accordingly, the Guidelines provide detailed explanations regarding the method, content and process of the applications made to the TİTCK for the renewal of manufacturing site permits issued prior to 2017. The TİTCK announced that it prioritizes the renewal of permits for medicine manufacturing facilities and it will further announce the renewal process of permits for radiopharmaceutical and raw material manufacturing facilities.

The Guidelines and its annexes are available on the TİTCK’s website (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies manufacturing human medicinal products. In this respect, companies operating in the healthcare industry should follow the TİTCK’s announcements and make their required applications for the renewal of their manufacturing site permits according to the directions set forth in the Guidelines.