Medicinal Herbal Teas Will Be Sold Only in Pharmacies
Official titleRegulation on Medicinal Herbal Teas
This Regulation published by the Türkiye İlaç ve Tıbbî Cihaz Kurumu establishes the licensing, production, and inspection principles aimed at marketing medicinal herbal teas with protective and therapeutic effects on human health, meeting pharmacopoeia quality, in a high-quality, effective, and safe manner, and selling them exclusively in pharmacies.
Before
There was no specific licensing and submission to market regulation for medicinal herbal teas.
After
For medicinal herbal teas to be sold in a quality, effective, and safe manner exclusively in pharmacies, the licensing, production, packaging, and inspection processes will be managed by the Türkiye İlaç ve Tıbbî Cihaz Kurumu (Turkish Medicines and Medical Devices Agency).
Details of the Regulation
The Regulation covers medicinal herbal teas consisting of tea preparations prepared industrially or extemporaneously in pharmacies and sold exclusively in pharmacies, prepared with a single drug or a mixture of multiple drugs. Food supplements and herbal and fruit teas marketed as food are outside the scope of this regulation. While natural persons applying for a license are required to hold at least a bachelor's degree and be authorized to practice their profession in Turkey, commercial companies are required to employ an 'authorized person' possessing these qualifications. During the licensing process, comprehensive information and documents are requested, such as commercial name, scientific name of the plant, application method, shelf life, storage conditions, packaging information, instructions for use, and analysis reports of compliance with the pharmacopoeia. In addition, administrative processes such as registering medicinal herbal teas in the electronic tracking system, having detailed labeling information on the packaging including Braille alphabet, cases of suspension or cancellation of the license, and license transfer are also defined in detail. Particularly in the use of plants specific to the flora of Turkey, submitting additional documents such as taxonomic record, endemic status information, and sustainable supply plan is mandatory. Detailed provisions have also been introduced regarding production sites and methods, as well as quality control processes.
Questions You Might Have
- Why will we only be able to find medicinal herbal teas in pharmacies with the new regulation?
- Due to the human health-protective and therapeutic effects of medicinal herbal teas, the Regulation has made it mandatory for their quality, efficacy, and safety to be licensed by the Türkiye İlaç ve Tıbbî Cihaz Kurumu and offered exclusively through controlled sales channels such as pharmacies.
- Will any herbal tea now be considered a medicinal herbal tea?
- No, the regulation defines only tea preparations prepared from specific herbal drugs of 'pharmacopoeia quality' and with 'therapeutic effects' as 'medicinal herbal tea'. Food supplements and herbal and fruit teas marketed as food are outside the scope of this regulation.
- What new obligations does this regulation bring for manufacturers?
- Manufacturers will be required to obtain a license from TİTCK for medicinal herbal teas, submit detailed documents proving the compliance of their products with pharmacopoeia standards and their safety, comply with packaging and labeling standards, and register their products in the electronic tracking system.
Key Terms
- Farmakope
- An official reference book containing quality standards, purity tests, preparation methods, and dosages of medicines and pharmaceutical substances.
- Drog
- Unprocessed or specially processed plants or plant parts of medicinal plants, usually dried, used for medicinal purposes.
- Majistral Preparat
- Medicines prepared extemporaneously by a pharmacist in pharmacies, formulated according to the specific needs of the patient.
- Elektronik Takip Sistemi (ETS)
- A centralized system that provides real-time tracking of all supply chain movements of medicinal products from production to the consumer using QR codes.
- Vijilans
- Activities of continuously monitoring, collecting, evaluating, and preventing potential side effects and safety issues of medicinal products after they are placed on the market.
Affected Sectors
- Pharmacy
- Herbal product producers
- Healthcare
- Medical devices
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REGAS Commentary
This Regulation aims to ensure that citizens access medicinal herbal teas in a safer and more controlled manner. It guarantees that such products, whose content, efficacy, or reliability might previously have been uncertain, are now products licensed by authorized authorities, sold exclusively in pharmacies, and compliant with specific quality standards. This situation is of great importance in terms of preventing the misuse or harmful use of herbal products as a result of perceiving them as 'medicines'. While introducing a new and comprehensive licensing and inspection obligation for manufacturers and importers, it is aimed at preventing unfair competition and under-the-counter production in this field. As pharmacies become the sole sales channel for these products, pharmacists will assume greater responsibility in their duties of providing accurate information and counseling.