Life Sciences Regulation in Turkey
Law No 1262 on Pharmaceutical and Medical Preparations (Pharmaceutical Code) is the primary legislation on pharmaceuticals. The Pharmaceutical Code is implemented through secondary legislation (for example, regulations, communiqués, and guidelines) that further regulate various aspects of the pharmaceutical market, including the Regulation on the Licensing of Medicinal Products for Human Use (Licensing Regulation). Although Turkey is not part of the EU, the pharmaceutical legislation is usually guided by EU practice, and most of the secondary legislation and soft law materials originate from EU directives.
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This article was first published in the PLC “Life Sciences Regulation in Turkey: Overview 2022” and is reproduced with the permission of the publisher, Thomson Reuters.