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Compliance and enforcement


What measures are in place to enforce the laws governing medicinal products?

In order to enforce the laws governing medicinal products, the most common enforcement measures are administrative and financial penalties (eg, suspending marketing authorisations, banning promotional activities or imposing administrative fines). Moreover, as per the Law on Preparation and Implementation of Technical Legislation Regarding Products and its secondary legislation, in case of an unsafe product, various penalties – namely, prohibition of placing the product on the market, recalling the product from the market or removing the products from the market partially or completely – can be imposed against manufacturers and distributors. The authority may also order the publication of the decision regarding the unsafe product by announcing to the public details of the unsafe product and the relevant measures imposed by the authority.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The mechanisms and regulations combating dishonest practices are performed under different frames. For instance, the Promotion Regulation includes certain provisions against activities which may be interpreted as bribery or dishonest practice in the pharmaceutical sector. In particular, the recently introduced rules on disclosure of value transfers to the Pharmaceuticals and Medical Devices Agency are expected to increase transparency and compliance within the sector. Internally applicable company standard operating procedures and certain industry rules also force pharmaceutical companies to pay the utmost attention to avoiding dishonest practices.

Another mechanism which aims to reduce the likelihood of counterfeit medicinal products is the Pharmaceutical Tracking System. Within such a system, all domestic and imported products can be pursued during their entire life cycle, starting from the manufacturing or importation, through to placing the product on the market and access by the end user. Moreover, the Ministry of Health and security forces conduct several activities to identify and capture individuals or organised groups involved in counterfeiting or smuggling pharmaceutical products. In general, actions arising from such dishonest practices may constitute a crime within different Turkish laws.

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