Representative obligation for medicines supplied from abroad

The regulation of the Turkish Medicines and Medical Devices Agency regarding the supply of medicines abroad has been published. It will be mandatory to have a representative resident in Turkey for medicines supplied from abroad. According to the regulation published in today's Official Gazette, foreign medicine suppliers will be able to become representatives provided that they meet the relevant obligations. It has been made mandatory for the representative of human medicinal products to be the sole authorized person for the activities to be carried out in Turkey within the scope of the regulation for the relevant human medicinal product. Applications for bulk drug supply from abroad will be made only by hospitals in accordance with the guide published by the Turkish Medicines and Medical Devices Agency. With the exception of bulk supply, no institution or organization will be able to directly apply to the agency within the scope of drug supply from abroad. Foreign medicine suppliers and representatives who are found not to comply with the provisions of the regulation may be subject to all kinds of sanctions in the relevant legislation, including import restrictions, and may be banned from activities. The existing import permits of foreign medicine suppliers on whom a ban decision is applied will be canceled. A gradual transition is envisaged in the enforcement of the provisions of the regulation on varying dates until June.