All operations involving veterinary health products are processed by the Ministry of Food, Agriculture and Livestock General Directorate of Food and Control. Drugs used in animals including immunological products (vaccine, serum and in-vivo diagnosis kits) are within the scope of veterinary medicinal products. In order to release a veterinary medicinal product to the market in Turkey, it must have a marketing license issued by T.R. Ministry of Food, Agriculture and Livestock, and licensed products must also have a sales permit. Marketing license processes for veterinary medicinal products are issued by the Ministry of Food, Agriculture and Livestock. In order for the applicants to meet the requirements of respective guidelines, they must consider the documentations from: (i) European Medicine Agency (EMA); International council of (previously conference on) Harmonisation’s Technical Requirements for Registration of Veterinary Medicinal Products (VICH); (iii) International Council of (previously Conference on) Harmonisation’s Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.
Changes requiring for licensed products or products for which license application has been issued previously, must be performed as per Regulation on Changes to be performed on Veterinary Medicinal Products that are licensed or in License Application Stage and the provisions of the guidelines issued in the same name of this regulation.