The Recall Regulation was published in Official Gazette number 29537 on 19 November 2015 ("Regulation"), entering into effect on the same date. The Regulation outlines an updated framework for investigating medicinal products which are defective or suspected of being defective in terms of consumers' health and safety, as well as related recall and withdrawal procedures.

The Regulation's scope includes human medicinal products, medical gases, traditional herbal medicinal products, special-purpose dietary food, homeopathic products, advance treatment products, human tissue and cell products, as well as all raw materials which fall under the responsibility of the Pharmaceuticals and Medical Devices Agency ("Agency"). The scope includes those who produce, import, store, distribute and sell these products, along with end-users.

The Agency is authorized to perform several actions regarding evaluation and recall of defective products. Products can be determined to be defective via an ex-officio inspection or in response to notifications made to the Agency. The Regulation outlines in detail the actions and inspections which can be carried out by the Agency.

The Regulation outlines duties and responsibilities of responsible companies and other institutions with regard to evaluation and recall of defective products. Among other obligations, responsible companies must inform the Agency about defective products, establish a recall procedure in compliance with the Regulation, as well as ensure effective and immediate recall procedures in line with the recall plan. The Regulations also imposes obligations on institutions and organizations which store, distribute and sell defective products.

The Regulation outlines reasons for recalls, initiation and finalization of recall procedures, as well as classification and limits for recalls. It also includes provisions regarding recall announcements, ceasing distribution and sale of defective products, as well as destruction or improvement of defective products.

The Regulation repeals the Regulation on Recall and Withdrawal of Pharmaceutical and Medical Drugs, Substances, Materials, Compounds and Herbal Preparations, published in Official Gazette number 19196 on 15 August 1986.

Please see this link for the full text of the Regulation (only available in Turkish).

Information first published in the MA | Gazette, a fortnightly legal update newsletter produced by Moroğlu Arseven

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