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What Has Changed with the Current Regulation on Licensing and What Should Companies Consider When Determining Their Strategies?


As CBC Law Firm, we cooperate with many national and international stakeholders in the healthcare sector on healthcare law and compliance. It is one of our principal areas of focus that we think requires dedicated expertise. In this respect, together with ASA Pharmaceutical Consulting, we have examined the current Regulation on the Licensing of Medicinal Products for Human Use ("Regulation"), identifying what it introduces and its effects on companies’ strategies.

The purpose of the Regulation is to determine the procedures and principles applied in the registration methods and practices for licensed medicinal products for human use in order to ensure that they have the desired efficacy and safety, and the required quality.

In this regard, the Regulation’s definition changes/additions, shortened application types, innovations in application evaluation procedures and principles, processes, and requirements regarding license renewal and suspension, conditional licensing, exceptional license procedure, and co-marketed products will be important to the current and future strategies of companies.

We hope to continue working, sharing information, and learning from each other for the benefit of the healthcare sector, which is one of Turkey's locomotive sectors in terms of foreign investment and local production and continues to gain great importance.

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