According to Law No. 7151 on Amendment of Several Laws and Decree Laws Related to Healthcare published in the Official Gazette of 5 December 2018, the amendments introduced to Law No. 984 on Stores Selling Toxic and Active Chemical Substances Used in Pharmacies, Arts and Agriculture (“Law“) establish several requirements related to human medicinal products procured from abroad.
The following obligations have been introduced with respect to pharmaceutical companies supplying human medicinal products into Turkey through procurement from abroad. These human medicinal products do not currently hold a marketing authorization (“MA“) in Turkey, or are not found in the market for various reasons. They are imported by the public institutions and organizations determined by the Ministry of Health, Social Security Institution and Turkish Pharmacists’ Association through prescription, and are provided directly to the patients in accordance with the Guidelines on Procurement and Use of Medicines from Abroad.
- The supplier must now apply for an MA within three years after the pharmaceutical is listed as a medicine procured from abroad, and the MA should be obtained at the latest within two years following the application.
- With respect to medicines that do not hold an MA or for which MA applications have not been made in accordance with the above provision, the President is entitled to determine whether to continue procuring these medicines from abroad.
- With respect to medicines procured from abroad prior to 5 December 2018, the three-year period starts from 5 December 2018.
- With respect to medicines for which MA applications were made prior to 5 December 2018, the two-year period for obtaining an MA starts from 5 December 2018.
With the amendment introduced in the Law, the Turkish Medicines and Medical Devices Authority may now impose an administrative fine ranging from TRY 2,000 to TRY 20,000 in the case of infringements of the Law.
The above provisions, which have entered into force within the scope of Turkey’s localization objectives, require multinational pharmaceutical companies that procure medicines into Turkey through their distributors to apply for an MA within the specified time limits.