From the Official Gazette: the Era of Pharmacies in Aromatherapy
Official titleRegulation on Aromatherapeutic Products
The regulation published by the Turkish Medicines and Medical Devices Agency (TİTCK) sets the rules regarding the licensing, production, and exclusive sale in pharmacies of aromatherapeutic products that have protective and therapeutic effects on human health.
Details of the Regulation
The 'Regulation on Aromatherapeutic Products' published by the Turkish Medicines and Medical Devices Agency establishes a legal framework for the standardization, safety, and pharmacy use of essential and fixed oils. According to the regulation, no aromatherapeutic product that has not been licensed by the Agency may be placed on the market or used in the preparation of magistral formulas in pharmacies. License applications may only be submitted by individuals residing in Türkiye who hold a bachelor's degree in fields such as medicine, pharmacy, chemistry, or biology, or by companies employing such individuals. The use of the Turkish language on product packaging is mandatory, and vital warnings such as 'Do not swallow', 'Sold only in pharmacies', and 'Used only for aromatherapy applications' must be included. Additionally, a QR code-based electronic tracking system will be established to monitor products and prevent counterfeiting. In this way, all movements from production to the pharmacy can be tracked.
Questions You Might Have
- How will the aromatherapy oils we buy from herbalist shops be affected by this regulation?
- Those sold as cosmetics or food are out of scope; however, all aromatherapeutic oils sold with therapeutic claims or to be prepared in a pharmacy by prescription can now only be sold in pharmacies.
- Will there be a QR code on the essential oil bottle I bought online?
- If the product is licensed as an 'aromatherapeutic product' under this regulation, a QR code will mandatorily be included on it for tracking purposes.
Key Terms
- majistral
- A medicine or mixture prepared in a pharmacy according to a prescription written by a physician.
- farmakope
- An official book containing the properties, purity levels, and analysis methods of drugs and raw materials.
- monograf
- A scientific document containing detailed standards and information about a specific drug raw material or plant.
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REGAS Commentary
This regulation aims to reduce the public health risks caused by essential oils sold uncontrollably in herbalist shops or online with 'therapeutic' claims. Aromatherapy products with health claims will now undergo strict medical inspections and will be delivered to the public only under the guidance of a pharmacist.