The Turkish Medicine and Medical Devices Authority (“TİTCK“) 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.
The TİTCK 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).
The Regulation on Variations brings new key definitions. Accordingly:
- Changes to the information provided in Article 8, 9, 10, 33, 34, 35 and 36 and Annex-1 of the Regulation on Marketing Authorization of Pharmaceutical Products (“Regulation on Marketing Authorization“)
- Changes to the packaging information or instructions of use as a consequence of changes in circumstances that affect the marketing authorization of the pharmaceutical product or the short product information, liabilities or abbreviations
Extension means a variation that is listed in Annex-1 of the Regulation on Variations and fulfills the conditions laid down therein. Extension applications are considered as new marketing authorization applications filed pursuant to the Regulation on Marketing Authorization. Approved applications will be granted with a new marketing authorization.
Variation applications concerning pharmaceutical products filed prior to the entry in force of the Regulation on Variations will be evaluated in accordance with the legislation in force at the time of application, unless otherwise requested by the marketing authorization owner.
Implementation of Variations
New rules have been introduced regarding the implementation of variations. Minor variations of type IA may be implemented before the relevant procedure specified in the Regulation of Variation starts. However, the implementation must immediately stop if the variation notification is refused by the TİTCK. Minor variations of type IB may only be implemented following the approval of the TİTCK or by the end of the period when the notification will be deemed accepted. Major variations of type II may only be implemented following the approval of the TİTCK. However, in cases affecting public health, such as pandemics, the TİTCK is entitled to bring new rules on the implementation of variations.
In variations that cause barcode changes, products with old barcodes will be allowed to be produced and placed on the market for a period of six months from the date of approval of the relevant variation. These products may be freely available on the market until their expiration date.
The Turkish Criminal Law No. 5237 will be applied in case of violation of the Regulation on Variations, where relevant. Additionally, Article 22 of the Regulation on Marketing Authorization will be applied where non-application of the variation causes quality, safety and efficacy issues for the pharmaceuticals.
The Regulation on Variations defines the requirements to follow for variations in pharmaceuticals. Companies working in this sector must carefully assess the Regulation on Variations and take necessary measures.