The Turkish Medicines and Medical Devices Agency (“TİTCK“) recently published on its website the draft Regulation on Foods for Medical Purposes (“Regulation“). Within the scope of harmonization with EU legislation, the Regulation is based on the EU Directive 609/2013/EC.
The Regulation sets out the labelling rules, procedures and principles for the authorization and packaging of products intended for medical use. The Regulation aims to ensure that the products are appropriate for human health and food safety.
The formulation of the products for medical purposes must be based on internationally recognized principles of medicine and nutrition. Companies must also ensure that the products meet the specific nutritional requirements when used in accordance with the specified instructions, and that the products are scientifically proved to be useful and effective.
In addition, companies must obtain an authorization certificate from the TİTCK before they introduce their products to the market. Companies should submit the relevant information and documents for the products listed under the Regulation to the TİTCK.
The draft Regulation on Foods for Medical Purposes is available here (in Turkish).
The TİTCK continues to provide guidelines for companies in the healthcare sector in line with EU regulations. Companies under the scope of the Regulation should follow the authorization, packaging and distribution requirements set forth under the Regulation before introducing their products to the market.