Medicinal product regulation and product liability in Turkey 2021
The primary legislation is the Code on Pharmaceuticals and Pharmaceutical Preparations (Ýspençiyari ve Týbbi
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, communiqués,
and guidelines) that further regulates all aspects of the pharmaceutical market. Although Turkey is not part of the
EU, the pharmaceutical legislation is usually guided by EU practice and most of the secondary legislations and soft
law materials originate from the applicable EU directives.
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This article was first published in the PLC “Medicinal product regulation and product liability in Turkey 2019” and is reproduced with the permission of the publisher, Thomson Reuters.