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ARTICLE · 05 JANUARY 2022

What Changes Does The New Regulation On Variations Bring?

Esin Attorney Partnership
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The Turkish Medicine and Medical Devices Authority ("TİTCK") published the Regulation on Variations to Pharmaceuticals with Marketing Authorization...

TurkeyFood, Drugs, Healthcare, Life Sciences
Can Sozer
Can Sozer
Yigit Acar
Yigit Acar
Ayça Doğu Öztürk
Ayça Doğu Öztürk
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The Turkish Medicine and Medical Devices Authority ("TITCK") published the Regulation on Variations to Pharmaceuticals with Marketing Authorization ("Regulation on Variations"). The Regulation on Variations defines new rules that will be applied to the changes to pharmaceuticals with marketing authorization.

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The TITCK published the Regulation on Variations in the Official Gazette No. 31693 on 18 December 2021. The Regulation on Variations, which is drafted in line with the relevant European Union legislation, brings new rules for the variations to pharmaceuticals with marketing authorization. The Regulation on Variations revoked the Regulation on Pharmaceuticals with Marketing Authorizations and Marketing Authorization Applications, and entered into force on the date of publication. The Regulation on Variations is available here (in Turkish).

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