Regulation On Aromatherapeutic Products Published In Türkiye

The Regulation on Aromatherapeutic Products (the "Regulation"), published in the Official Gazette dated 2 July 2026 and numbered 33298, establishes, for the first time, a comprehensive regulatory framework governing the authorisation, manufacture, importation, packaging, distribution, placing on the market and supervision of aromatherapeutic products.

The Regulation introduces aromatherapeutic products as a distinct product category subject to a separate marketing authorisation and regulatory supervision regime under the supervision of the Turkish Medicines and Medical Devices Agency ("TITCK"). In particular, it introduces significant changes concerning marketing authorisation procedures, manufacturing standards, electronic product tracking, distribution channels and post-authorisation compliance requirements.

Accordingly, manufacturers, importers, marketing authorisation holders and companies operating in the pharmaceutical and pharmacy sectors should review their existing product portfolios and assess their compliance with the new regulatory framework.

Scope of the Regulation and Key Features

The Regulation governs the authorisation of aromatherapeutic products consisting of, or containing, standardised essential oils and carrier vegetable oils approved by TITCK.

Food supplements, cosmetic products, medical devices and traditional herbal medicinal products are expressly excluded from its scope.

This distinction is particularly important for determining which regulatory regime will apply to products with similar compositions.

Marketing Authorisation Requirement

Under the Regulation, no aromatherapeutic product may be placed on the market or used in the preparation of magistral products in pharmacies unless it has obtained a marketing authorisation from TITCK.

Marketing authorisation applications will principally be submitted electronically, and applicants must satisfy specified professional qualification requirements.

Accordingly, the Regulation establishes a centralised marketing authorisation system administered by TITCK based on predefined technical criteria.

Strengthened Quality, Safety and Efficacy Requirements

The Regulation sets out detailed documentation requirements for marketing authorisation applications, including information relating to product composition, manufacturing processes, quality control, stability studies and, where necessary, pre-clinical and clinical studies.

The new framework is intended to ensure that aromatherapeutic products are assessed not only on the basis of their traditional use but also against scientific evidence, quality and safety standards.

Consequently, the technical documentation required for marketing authorisation applications is expected to become significantly more comprehensive.

New Packaging and Product Traceability Requirements

The Regulation introduces detailed rules regarding mandatory product labelling, package information, instructions for use, mandatory warnings and QR code implementation.

In addition, aromatherapeutic products must be registered in the electronic product tracking system, enabling traceability throughout the supply chain from manufacture to pharmacy.

These requirements are intended to enhance product safety and improve traceability across the market.

Detailed Post-Authorisation Obligations

The Regulation contains detailed provisions governing variations to marketing authorisations, transfers of authorisations, suspension and cancellation procedures, and marketing permit processes.

Marketing authorisation holders are also subject to continuing obligations regarding ongoing product safety monitoring, implementation of updates reflecting scientific developments and ensuring the continued availability of products on the market.

Accordingly, the Regulation introduces a lifecycle-based compliance model under which regulatory obligations continue throughout the entire period during which a product remains on the market, rather than ending once the marketing authorisation has been obtained.

Distribution Channels

The Regulation provides that aromatherapeutic products, whether prescription-only or non-prescription, may be sold exclusively through pharmacies.

Promotional activities relating to such products are likewise subject to the rules and procedures determined by TITCK.

This change may require companies currently relying on non-pharmacy sales models or alternative distribution channels to reassess their existing commercial practices.

Key Considerations for Businesses

The Regulation is particularly relevant for:

• manufacturers of aromatherapeutic products;
• importers;
• marketing authorisation holders;
• companies operating in the pharmacy sector; and
• businesses engaged in the essential oils and herbal products industry.

Companies should in particular:

• review whether their existing product portfolios fall within the scope of the Regulation;
• reassess product classifications;
• identify products requiring marketing authorisation;
• align packaging, labelling and QR code practices with the new requirements and assess their obligations under the electronic product tracking system; and
• review existing sales and distribution models in light of the new regulatory framework.

Businesses that have previously marketed products under different regulatory regimes should carefully reassess the regulatory classification of their products.

Conclusion

The Regulation establishes the first comprehensive regulatory framework specifically governing aromatherapeutic products in Türkiye and introduces an integrated system administered by TITCK covering marketing authorisation, manufacturing, placing on the market and regulatory supervision.

Companies operating in this sector should review not only their product classifications but also their marketing authorisation processes, technical dossiers, packaging and labelling, sales channels and supply chain arrangements to ensure compliance with the new requirements. Early compliance planning will be critical to ensuring business continuity and mitigating potential regulatory enforcement risks.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.