The Turkish Medicines and Medical Devices Agency (TİTCK) has introduced a comprehensive regulatory framework for aromatherapeutic products through the Regulation on Aromatherapeutic Products, published in the Official Gazette on 2 July 2026. The regulation establishes detailed requirements governing the authorisation, manufacturing, importation, marketing, and post-market obligations of aromatherapeutic products in Türkiye.
Purpose of the Regulation
The regulation aims to ensure that aromatherapeutic products intended to protect human health, support treatment, or contribute to therapeutic care are placed on the Turkish market with demonstrated quality, safety, and efficacy.
Its scope covers authorisation applications for products containing:
- Standardised essential oils
- Fixed oils
- Aromatherapeutic formulations containing these ingredients
Products Excluded from the Scope
The regulation does not apply to:
- Food supplements
- Cosmetic products
- Medical devices
- Traditional herbal medicinal products containing essential oils
These products will continue to be regulated under their respective legislative frameworks.
Mandatory Authorisation Requirement
Under the new regulation, no aromatherapeutic product may be placed on the Turkish market without obtaining a marketing authorisation from TİTCK.
Furthermore, unauthorised products may not be used by pharmacies for magistral preparations.
Applications will generally be submitted electronically, and applicants must satisfy specific qualification and competency requirements established by the Agency.
Technical Dossier Requirements
The regulation introduces detailed documentation requirements for marketing authorisation applications.
Applicants must provide scientific and technical information for all:
- Essential oils
- Carrier oils
- Hydrosols
Included in the formulation, covering:
- Botanic identity
- Manufacturing processes
- Intended use
- Product specifications
- Safety data
- Analytical reports
- Pesticide testing results
- Compliance with applicable pharmacopoeial monographs
Manufacturing, Labelling, and Traceability
Beyond authorisation requirements, the regulation establishes obligations relating to:
- Good Manufacturing Practices (GMP)
- Manufacturing facilities
- Packaging
- Labelling
- Electronic traceability
- Post-market surveillance and safety monitoring
Additional provisions also apply to ingredients derived from endemic plant species and flora native to Türkiye, introducing sustainability and biodiversity protection requirements.
Impact on the Industry
The new regulation creates a dedicated regulatory framework for aromatherapeutic products in Türkiye and provides greater clarity regarding market access requirements.
Manufacturers, importers, marketing authorisation holders, product development teams, and regulatory affairs professionals will need to review their products and documentation to ensure compliance with the new requirements before placing aromatherapeutic products on the Turkish market.