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Medicinal herbal teas to be sold only in pharmacies under new regulation
The regulation on the production, licensing and sale of medicinal herbal teas has been published in the Official Gazette. Under the new rules, these products will only be sold in pharmacies, tracked via QR codes, and a degree requirement will be sought for licensing.
The regulation establishes the procedures and principles for the production, licensing, and sale of medicinal herbal teas. By making these products available only through pharmacies, safe access has been enhanced. Accordingly, medicinal herbal teas will be licensed by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health, following scientific and technological evaluation.
Inspection and market surveillance of licensed medicinal herbal teas will also be carried out by the Ministry. Complete applications will be concluded within 90 days, and each medicinal herbal tea will be registered in the Product Tracking System (ÜTS) with a QR code. Thus, all movements of the products, from production or import line to pharmacy shelves, on a per-box basis will be monitored in real time.
Pharmacy products can be prepared from licensed medicinal herbal teas. The content and intended uses of medicinal herbal teas to be prepared as magistral (personalized) in a pharmacy laboratory will be determined by the monographs and guidelines to be published by TİTCK. Thus, the therapeutic efficacy and safety areas of medicinal herbal teas will be clarified.
Products in pharmacies will be prepared from medicinal herbal teas licensed by the Ministry of Health and from raw materials/drugs of pharmacopoeia quality. Degree and expertise requirement introduced for license applications. With the new regulation, people who will market and produce these products, which directly concern human health, will be required to be graduates of relevant fields.
Individuals applying for a license must have a bachelor's degree, and companies must employ an authorized expert.
Furthermore, reports to be submitted on the quality, safety, efficacy and pharmacopoeia compliance of the product must be prepared by individuals who are graduates of institutions providing education in medicine, pharmacy, chemistry or biology, who are authorized to practice their profession in Turkey, and who have expertise in the relevant field or a phytotherapy certificate.
Herbal teas in supermarkets separated from medicinal herbal teas. 'Herbal and fruit teas' and 'food supplements' used for purposes such as food, pleasant taste and supplementation to normal nutrition are legally distinctly separated from medicinal herbal teas. Sales of food-purpose teas, which continue to be under the remit of the Ministry of Agriculture and Forestry, will continue in supermarkets, herbalists and similar places.
However, licensed 'medicinal herbal teas' approved by the Ministry of Health, with standardized dosage, preparation method, special usage warnings and production standards, will only be available from pharmacies. Packaging standardization to be implemented. With the regulation, product packaging and instructions for use will also meet the highest safety standards.
The scientific names of the plants contained in medicinal herbal teas will be displayed on the outer packaging in Turkish and Latin, along with their quantitative ratios.
Use of endemic plants in Turkey to be supported and protected. Under the regulation, raw materials obtained from plants found in Turkey's flora or endemic to Turkey may be used in the production of medicinal herbal teas, provided they are supported by scientific data on quality, safety and efficacy.
However, for the protection of natural populations and ecological balance, the application file must include taxonomic records of the plants, sustainable supply plans, cultivation documents, and for endangered species, declarations of compliance with the CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) convention.
Regulation to open doors to international markets. A certificate of compliance with international Good Manufacturing Practices (GMP) guidelines will be required for all production processes, including those at overseas manufacturing facilities.
While the regulation makes licensing and market supply processes more transparent and predictable, it also aims to facilitate the access of our domestic products, which have passed these rigorous inspections and have been proven by quality assurance laboratory analyses and stability tests, to international markets and to gain competitiveness in the global market.
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