The Regulation on Licensing of Medicinal Products for Human Use Has Been Published

The Regulation on Licensing of Medicinal Products for Human Use (“Regulation”) was published by the Turkish Medicines and Medical Devices Agency (“Authority”) in the Official Gazette dated 11 December 2021 and numbered 31686.

The Regulation regulates the procedures and principles to be applied in the registration procedures and the practices regarding the licensed human medicinal products in order to ensure that the medicinal products for human use have the desired efficacy and safety and the required quality.

• No medicinal product for human use that is not licensed by the Agency can be placed on the market.
• Real or legal persons residing in Turkey shall apply for a license to the Agency in accordance with the Regulation in order to obtain a license for placing a medicinal product for human use on the market.
• Licensing applications can be made by applicants throughout the year.
• The licensing process, can only be started in February, May, August and November, taking into account the licensing capacity of the Authority

You can reach the further information here.

Kind regards,

Zumbul Attorneys at Law

info@zumbul.av.tr

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