Medicine and Device Registration in Türkiye: Documents

Foreign manufacturers registering medicines or medical devices in Türkiye deal with the Turkish Medicines and Medical Devices Agency (TİTCK). Its announcements set strict rules for documents from abroad.

Medicines

In its notice to pharmaceutical companies, TİTCK states that all official documents obtained from abroad and submitted for marketing authorisation must bear an apostille or be certified by a consulate.

Medical devices

An announcement of 2019 (KK-9) sets the rules for documents uploaded to the product tracking system (ÜTS). For a foreign manufacturer's documents, such as an EC certificate or declaration of conformity, the version with an apostille, or certified by the Turkish embassy or consulate in the manufacturer's country, is uploaded in full. The original of the apostilled or consular-certified document is accepted; a photocopy or a notarised copy of it is not. The same rule applies to a domestic manufacturer's EC certificate issued in a foreign language.

An electronic apostille issued by the competent authorities of a Hague Convention state is accepted if the apostilled document can be reached and verified through the query tool stated on it. Where a notified body has issued an EC certificate electronically with an electronic signature that can be verified, no apostille or consular certification is needed.

A complete Turkish translation by a sworn translator is uploaded alongside, and in the relevant section only the Turkish part of the translator-certified document. The physical documents are then sent to the Agency's records unit with a petition stating the ÜTS reference number.

We translate certificates and declarations into Turkish in Ankara through translators sworn before a Turkish notary. TİTCK decides on registration; check its current announcements, as the device rules quoted here date from 2019.