Regulation On Medicıial Herbal Teas

The Regulation on Medicinal Herbal Teas (the “Regulation”), published in the Official Gazette dated 2 July 2026 and numbered 33298, establishes for the first time a comprehensive framework governing the authorisation, manufacture, importation, packaging, distribution, placing on the market and supervision of medicinal herbal teas. While the Regulation creates a separate authorisation system for medicinal herbal teas sold exclusively through pharmacies, it excludes food supplements and herbal and fruit teas marketed as food products from its scope.

When considered together with the Regulation on Aromatherapeutic Products and the Regulation Amending the Regulation on the Authorisation of Traditional Herbal Medicinal Products, both published on the same date, the Regulation constitutes an important part of the broader restructuring of the regulatory framework applicable to plant-based health products.

Scope of the Regulation and Key Features

The Regulation governs the authorisation of medicinal herbal teas consisting of a single herbal substance or a combination of multiple herbal substances and intended for therapeutic use. Food supplements and herbal and fruit teas placed on the market as food products are excluded from its scope.

This distinction is important for determining the regulatory regime applicable to products with similar compositions and for ensuring their correct classification.

Marketing Authorisation Requirement Introduced for Medicinal Herbal Teas

Under the Regulation, no medicinal herbal tea may be placed on the market or used in the preparation of magistral products in pharmacies unless it has been authorised by the Turkish Medicines and Medical Devices Agency (“TITCK”). Marketing authorisation applications will principally be submitted electronically, and applicants must satisfy specified professional qualification requirements.

The Regulation therefore introduces a centralised, technically driven marketing authorisation system for medicinal herbal teas, administered by TITCK and based on technical criteria.

Quality, Safety and Scientific Assessment Requirements Regulated in Detail

The Regulation sets out detailed information and documentation requirements for marketing authorisation applications. It includes comprehensive provisions concerning pharmacopoeial compliance, quality analyses, manufacturing methods, stability studies, pre-clinical and clinical studies where necessary, pharmacovigilance obligations and product safety requirements. Special application requirements are also introduced for herbal substances obtained from endemic plant species.

This approach is intended to ensure that medicinal herbal teas are assessed not only on the basis of traditional use but also against scientific quality and safety criteria. Consequently, the scope of the technical dossier required for marketing authorisation applications has been significantly expanded.

Packaging and Electronic Tracking System Made Mandatory

The Regulation introduces detailed obligations concerning the information to be included on product packaging, instructions for use, QR-code implementation and the electronic tracking system.

Medicinal herbal teas must be traceable at individual-pack level from manufacture through to the pharmacy as the final point of sale, and all product movements must be recorded through the electronic tracking system.

These requirements are intended to enhance product safety and ensure supply-chain traceability.

Post-Authorisation Processes and Ongoing Compliance Obligations Regulated

The Regulation contains detailed provisions governing variations to marketing authorisations, transfers, suspension or cancellation of authorisations and sales-permit procedures. Marketing authorisation holders are also required to monitor scientific developments affecting the quality, safety and efficacy of their products, make the necessary updates and ensure the continued availability of products on the market.

These provisions transform marketing authorisation from a one-off approval process into a dynamic compliance mechanism covering the entire lifecycle of the product.

Sales Channels and Product Classification Clarified

Medicinal herbal teas falling within the scope of the Regulation may be sold, whether on prescription or without prescription, exclusively through pharmacies. The same product name may not be used to market these products as food supplements, cosmetic products, medicinal products for human use, medical devices or aromatherapeutic products.

This amendment aims to ensure the correct classification of products and prevent consumers from being misled by the marketing, under the same or a similar name, of products subject to different regulatory regimes.

Key Considerations for Companies

The Regulation is particularly relevant to:

• manufacturers of medicinal herbal teas;
• importers;
• marketing authorisation holders;
• companies operating in the pharmacy sector; and
• manufacturers developing herbal products.

In this context, companies should:

• assess whether their existing product portfolios fall within the scope of the Regulation;
• review their product classifications;
• identify products requiring marketing authorisation;
• prepare technical dossiers and marketing authorisation applications in accordance with the new criteria;
• align their packaging, labelling and QR-code practices with the new requirements;
• analyse their obligations under the electronic tracking system;
• reassess their sales and distribution models in light of the new rules; and
• review their post-authorisation quality and product-safety obligations.

Herbal products that have previously been placed on the market under different regulatory regimes should, in particular, be reassessed in light of the new product classifications.

Conclusion

The Regulation establishes the first comprehensive regulatory framework specifically applicable to medicinal herbal teas and subjects the authorisation, manufacture, placing on the market and market-surveillance processes for these products to an integrated system administered by TITCK.

Companies operating in the medicinal herbal tea sector should therefore review not only their product portfolios, but also their product classifications, marketing authorisation procedures, technical dossiers, packaging and labelling, electronic tracking-system obligations and sales channels in light of the new framework. Early compliance work will support business continuity and help mitigate potential regulatory 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.