The Pharmaceutical and Medical Preparations Law No. 1262 is the main pharmaceutical licenses law applied in Turkey. The law is valid for almost a century, since 1928.
With the Law No. 7496 published in the Turkish Official Gazette dated 01.03.2024, significant changes were made regarding drug licensing and packaging in Turkey.
Accordingly, with the amendment made in the Pharmaceutical and Medical Preparations Law No. 1262 (the ), the procedure of finalizing the treatment of the preparations made domestically or brought abroad within two months from the date of their arrival to the Ministry of Health and issuing a license to the applicant has been adopted.
The provision saying “However, in cases where it is necessary to carry out scientific studies on the preparation or to determine its health effects through experience, this period may be extended as much as necessary.” has been abolished and the administration’s ability to extend the licensing process as long as it wishes/unlimitedly has been eliminated.
In addition, with the amendment made in the Article 12 of the Law No. 1262, the provision regarding the price being written on the outer packaging/box of medicines is being abolished.
With the regulation made in the Stamp Duty Code No. 492, the stamp duty applied to drug licenses has been increased. It was redetermined as TRL 27,515.80 for those imported from abroad and TRL 13,733.10 for those manufactured domestically.
