The New Regulation on the Licensing of Medicinal Products for Human Use (“Regulation”) was published in the Turkish Official Gazette on 11 December 2021. This has been awaited as expected since 8 November 2018 when the Turkish Pharmaceutical and Medical Device Institution (“Institution”) published the draft Regulation.

The Regulation brings changes and introduces new concepts with a view to harmonizing with the EU directive numbered 2001/83/EC and keeping up with the necessities and needs of the time.

The changes brought by the Regulation mainly aims to clarify certain matters relating to the licensing process, facilitate licensing procedures, ensure transparency and eliminate the difficulties commonly encountered in the licensing process. There have been slight changes on the draft Regulation which was published on 8 November 2018 for the purpose of addressing the current needs of the sector.

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