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Medicinal product regulation and product liability in Turkey: overview

REGULATORY OVERVIEW

What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The primary legislation is the Code on Pharmaceuticals and Pharmaceutical Preparations (İspençiyari ve Tibbi Müstahzarlar Kanunu) No. 1262 (Pharmaceutical Code) which was published in the Official Gazette dated 26 May 1928. The Pharmaceutical Code is implemented through secondary legislation (such as regulations, communiques, and guidelines) that further regulates all aspects of the pharmacutical market.

Additionally, sector-specific legislation may have an impact on pharmaceuticals, although such legislation applies to various other fields that intersect with pharmaceuticals and are not regulated under the Pharmaceutical Code.

Regulatory authorities

The Turkish state is the main buyer in the pharmaceutical sector due to the broad coverage of public health insurance (with the entry into force of the General Health Insurance legislation, it is expected that everyone residing in Turkey will be incuded in the state health insurance coverage).

 

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© Thomson Reuters 2018                                                                                                                       
This article was first published in the Life Sciences Global Guide 2018                                                   
and is reproduced with the permission of the publisher, Thomson Reuters
.

The law is stated as at 1 May 2018.