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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. Various other legislation applies in specific areas.

Secondary legislation (regulations, communiques and guidelines) regulates the details in relation to each aspect of the pharmaceutical market.

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 planned to include every person residing in Turkey in the health insurance coverage).

The main regulator is the Ministry of Health. It deals with the pharmaceutical sector through its independent institution, the Pharmaceutical Product and Medical Device Institution (Institution). The Institution regulates all aspects of pharmaceuticals including marketing authorisation, production, pricing, import/export, and clinical trials.

 

 

© Thomson Reuters 2016                                                                                                                         
This article was first published in the Life Sciences Global Guide 2016/17                                                     
and is reproduced with the permission of the publisher, Thomson Reuters
.

The law is stated as at 1 April 2016.