Regulation on Aromatherapeutic Products
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This regulation creates a licensing framework for aromatherapeutic products in Turkey, including standardized essential oils and carrier oils used directly or in pharmacy-prepared mixtures. It aims to make sure these products are placed on the market with clear quality, safety, and effectiveness standards. The rules mainly affect companies and individuals applying for product licenses from the Turkish Medicines and Medical Devices Agency. Products already regulated as food supplements, foods, cosmetics, medical devices, or traditional herbal medicines are excluded, but borderline aromatherapy products may still be reviewed by the Agency.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Introduces a licensing route for aromatherapeutic products and standardized essential oils in Turkey
- Defines which essential oil and carrier oil products fall under the Turkish Medicines and Medical Devices Agency’s review
- Excludes products already regulated as food supplements, foods, cosmetics, medical devices, or traditional herbal medicines
Obligations
What this law requires
Real persons or commercial companies placing standardized essential oils or carrier fixed oils on the market for direct use or for use in pharmacy-prepared mixtures must obtain an aromatherapeutic product licence from the Turkish Medicines and Medical Devices Agency.
Aromatherapeutic product licence applications for products containing essential oils or mixtures must be limited to products prepared according to Agency-published monographs or products whose composition and intended use the Agency finds appropriate.
Products prepared for internal use are excluded from aromatherapeutic product licence applications under this regulation and must not be submitted as covered aromatherapeutic products under this framework.
Other products prepared for use in aromatherapy that do not fall within the listed covered or excluded categories must be submitted for evaluation by the Turkish Medicines and Medical Devices Agency.