What changes are made in the new variation regulations?

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The Turkish Medicines and Medical Devices Authority (“TİTCK“) published the Modifications of Pharmaceuticals with Marketing Authorization Regulations (“Variation RegulationThe Variations Regulation sets out new rules that will be applied to modifications of pharmaceutical products with marketing authorization.

New development

The TİTCK published the Variations Regulation in Official Gazette No. 31693 on December 18, 2021. The Variations Regulation, which is drafted in accordance with relevant European Union legislation, brings new rules for variations of pharmaceuticals with marketing authorization. The Amendments Regulations repealed the Pharmaceuticals with Marketing Authorization and Marketing Authorization Regulations and entered into force on the date of publication. The variation rules are available here (in Turkish).

What’s up?

New definitions

The Variation Regulation provides key new definitions. As a result:

  1. Amendments to the information provided in Articles 8, 9, 10, 33, 34, 35 and 36 and in Annex 1 of the Regulation on the marketing authorization for pharmaceutical products (“Marketing authorization regulation“)
  2. Changes to information on the packaging or instructions for use as a result of changes in circumstances which affect the marketing authorization of the pharmaceutical product or short product information, responsibilities or abbreviations

Extension means an amendment which is listed in Schedule 1 of the Amendments Regulation and which fulfills the conditions set out therein. Extension requests are considered to be new marketing authorization applications filed in accordance with the marketing authorization regulation. Approved applications will be granted with a new marketing authorization.

Modification requests concerning pharmaceutical products submitted before the entry into force of the Amendments Regulation will be assessed in accordance with the legislation in force at the time of the request, unless otherwise requested by the marketing authorization holder.

Implementation of variants

New rules have been introduced regarding the implementation of variations. Minor Type IA variations may be implemented before the start of the relevant procedure specified in the variation regulation. However, the implementation must immediately stop if the variation notification is refused by the TİTCK. Minor variations of type IB can only be implemented after the approval of TİTCK or before the end of the period during which the notification will be deemed accepted. Significant variations of type II can only be implemented after approval by TİTCK. However, in cases affecting public health, such as pandemics, the TİTCK is entitled to make new rules on the implementation of variations.

In variations which result in barcode changes, products with older 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 in the market until their expiration date.

Punishments

Turkish Criminal Law No. 5237 will be applied in the event of violation of the Variation Regulation, if any. In addition, Article 22 of the Marketing Authorization Regulation will be applied when the non-application of the variation leads to quality, safety and efficacy issues for pharmaceutical products.

Conclusion

The Variations Regulation defines the requirements to be followed for variations of pharmaceutical products. Companies working in this sector should carefully assess the variation regulation and take the necessary action.

The content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may be termed a “lawyer advertisement” requiring notice in some jurisdictions. Past results do not guarantee similar results. For more information, please visit: www.bakermckenzie.com/en/disclaimers.


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