Veterinary Medicines in Türkiye: Foreign Documents

Veterinary medicinal products made abroad need a marketing authorisation from the Ministry of Agriculture and Forestry under the regulation on veterinary medicinal products. The application is made to the Ministry's Directorate General with a dossier containing the information and documents the regulation lists, prepared according to the guideline in force.

Documents from abroad

For a product already authorised abroad, the dossier includes the summary of product characteristics and/or the leaflet or label specimen and a free sale certificate for the product, and, if any authority has refused a marketing authorisation before, the detailed reasons for that decision. It also includes the good manufacturing practice certificate of the manufacturing site or sites accepted by the Ministry, unless the site has been certified by the Ministry, and the qualitative and quantitative particulars of all the product's components in common terminology.

The regulation's certification rule is specific: where the product is authorised abroad, the composition document, the GMP certificate and the free sale documents must be approved by the competent authorities of the country concerned and submitted with a sworn Turkish translation. The regulation does not mention apostille or consular certification for them; ask the Directorate General which form it accepts.

Rights holder and labels

The dossier also includes an authorisation document from the rights holder abroad showing that the applicant alone is authorised for import into Türkiye, the marketing authorisation and placing on the market. The regulation does not set a certification or translation rule for this document. Products authorised abroad with labels in a foreign language may be supplied with Turkish labels stuck on so that they do not come off, and with a Turkish leaflet. The Ministry carries out scheduled GMP inspections, announced in advance, at manufacturing sites in Türkiye and abroad.

We prepare sworn Turkish translations of free sale certificates, GMP certificates and composition documents in Ankara through translators sworn before a Turkish notary. The Ministry decides on authorisation.