Medicine Licences in Türkiye: Foreign Documents

Medicines made abroad are licensed in Türkiye by the Turkish Medicines and Medical Devices Agency (TİTCK) under the regulation on the licensing of medicinal products for human use. The applicant applies to the Agency with a dossier prepared according to the regulation's first annex and the documents it lists, and several of those documents come from foreign authorities and companies.

Apostille, language and translation

The regulation is direct: all official documents obtained from abroad must bear an apostille or be certified by a consulate. TİTCK repeated this in an announcement to pharmaceutical companies, citing the same provision. All documents are in principle submitted in Turkish; parts the Agency accepts may be in English. Documents in other languages must come with a sworn Turkish translation. Where a sworn translation cannot be made in Türkiye, a sworn translation into Turkish or English made in another country may be accepted.

Foreign documents in the dossier

For imported or licensed products, the dossier includes the list of other countries where licences were applied for and a licence copy or a Certificate of a Pharmaceutical Product approved by the health authority of one of them. It also includes documents from competent authorities, or from authorities of countries with a mutual recognition agreement, showing that the finished product and the active substance are manufactured under good manufacturing practice, and the summary of product characteristics, patient leaflet and packaging approved by the authorities of countries where the product is on the market.

The licensor issues an authorisation document stating that the applicant is its sole authorised representative for importing, licensing and selling the product in Türkiye, or for licensing, manufacturing and selling it under licence. Active substances obtained from abroad need a conformity letter prepared under the Agency's guideline. For blood products and immunological products, batch release certificates certified by a health authority must bear an apostille or consular certification when they come from abroad.

We prepare sworn Turkish translations of foreign certificates and authorisation documents in Ankara through translators sworn before a Turkish notary. TİTCK decides on licences.