A new era for medicinal herbal teas: Licensing, QR codes, and pharmacy requirements introduced
With the regulation published in the Official Gazette, new rules have been established for the production, licensing, tracking, and sale of medicinal herbal teas.
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A new regulation regarding medicinal herbal teas has been published in the Official Gazette and has entered into force. The regulation redefines the procedures and principles to be followed, from the production and licensing of these products to their market surveillance and sale.
In the new era, it is envisioned that medicinal herbal teas will be offered to citizens exclusively through pharmacies. The products will be examined and licensed from a scientific and technological perspective by the Turkish Medicines and Medical Devices Agency (TİTCK), which operates under the Ministry of Health.
LICENSING AND TRACKING PROCESS
According to the regulation, complete license applications will be finalized within 90 days. Every medicinal herbal tea that receives a license will be registered in the Product Tracking System (ÜTS) using a QR code system. This will allow for real-time tracking of the products' movements on a per-unit box basis, from the production or import stage to pharmacy shelves.
A framework has also been established for medicinal herbal teas that are requested to be prepared as magistral (custom-made) products for individuals in pharmacies. The content and intended uses of these products will be defined by monographs and guidelines to be published by TİTCK. Products prepared in pharmacies will be required to consist of medicinal herbal teas licensed by the Ministry of Health and raw materials or drugs of pharmacopoeia quality.
The regulation also introduces education and expertise requirements for those who will produce and market the products. Natural persons applying for a license must hold a bachelor's degree, while companies will be required to employ an authorized expert. Reports on quality, safety, efficacy, and compliance with the pharmacopoeia must be prepared by individuals who have graduated from the fields of medicine, pharmacy, chemistry, or biology, are authorized to practice their profession in Turkey, and possess expertise or a phytotherapy certificate in the relevant field.
Standardization will also be ensured for packaging and user instructions. The scientific names of the plants contained in the medicinal herbal teas will be included on the outer packaging in both Turkish and Latin, along with their quantitative ratios.
The regulation also paves the way for the use of plants found in the Turkish flora or endemic to Turkey in the production of medicinal herbal teas. However, for these raw materials, it will be mandatory to support quality, safety, and efficacy with scientific data; and to submit taxonomic records, sustainable supply plans, cultivation documents, and, where necessary, CITES compliance declarations to protect natural populations.
In production processes, a certificate of compliance with international Good Manufacturing Practice (GMP) guidelines will be required, including for facilities abroad. The goal is to make the licensing and market supply processes more transparent and to facilitate the access of audited domestic products to international markets.