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
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
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