Major Amendments To The Regulation On The Authorisation Of Traditional Herbal Medicinal Products

The Regulation Amending the Regulation on the Authorisation of Traditional Herbal Medicinal Products (the “Amendment Regulation”), published in the Official Gazette dated 2 July 2026 and numbered 33298, introduces significant amendments to the procedures and principles governing the authorisation of traditional herbal medicinal products.

The Amendment Regulation updates product definitions and marketing authorisation criteria; restructures the application process; amends the requirements relating to manufacturing sites and applicants; introduces new obligations for products derived from endemic plant species; and revises the system for assessing the continued validity of marketing authorisations.

When considered together with the Regulation on Aromatherapeutic Products, which entered into force on the same date, these amendments form part of the broader restructuring of the regulatory framework applicable to plant-based health products.

Aromatherapeutic Products Made Subject to a Separate Regulatory Regime

The Amendment Regulation removes medicinal products used in aromatherapy from the scope of the Regulation on the Authorisation of Traditional Herbal Medicinal Products (the “Regulation”) and subjects them to a separate authorisation and supervision regime under the Regulation on Aromatherapeutic Products, which entered into force on the same date. As a result, traditional herbal medicinal products and aromatherapeutic products are now governed by distinct regulatory frameworks, providing a clearer separation between the two product categories.

Scope and Definitions Updated

The definition of “traditional herbal medicinal product” under the Regulation has been revised. The traditional use of a product may now be demonstrated not only through bibliographic data but also by a scientific assessment conducted by the Turkish Medicines and Medical Devices Agency (the “Agency”) or through verifiable documentation.

The Regulation also introduces new definitions relating to “well-established use”, “benefit-risk balance”, the “Priority Assessment Board” and products derived from endemic plants.

These amendments indicate that the scientific criteria applied in marketing authorisation assessments have been broadened and that the Agency has been granted more extensive assessment powers.

Marketing Authorisation Application Requirements Expanded

The provisions governing marketing authorisation applications have been revised.

In this context:

• the range of professional groups eligible to take part in marketing authorisation applications has been expanded;
• applications based on “well-established use” have been expressly accepted; and
• monographs published by the European Medicines Agency (EMA) may now be used as references in abridged marketing authorisation applications.

These amendments strengthen alignment with European Union practice and broaden the reference sources available for marketing authorisation applications, particularly for companies with international product portfolios.

Additional Application Requirements Introduced for Endemic Plants

The documentation required for marketing authorisation applications concerning herbal substances and preparations obtained from plants found in the flora of Türkiye or from plant species endemic to Türkiye has been significantly expanded.

Accordingly, the application dossier must include a sustainable utilisation plan, controlled cultivation or production documents, permits issued by the General Directorate of Forestry and, where required, CITES documentation.

The marketing authorisation process therefore now includes additional obligations relating not only to product safety but also to the protection of biodiversity and the sustainable use of natural resources.

Assessment Process for the Continued Validity of Marketing Authorisations Revised

Marketing authorisation holders are now required to submit updated data on quality, safety and efficacy to the Agency at the end of the first five-year period following the date of authorisation.

Following a scientific assessment of the submitted data, the Agency will decide whether the marketing authorisation may remain valid. The rejection of a renewal application, where the subsequent objection process is also unsuccessful, has additionally been included among the grounds for cancellation of the marketing authorisation.

This amendment demonstrates that the authorisation process is not limited to the initial application stage. Products will continue to be scientifically monitored while they remain on the market, and marketing authorisations will be subject to reassessment at specified intervals.

Manufacturing Sites and Transitional Period Revised

The Amendment Regulation updates the documentation requirements applicable to manufacturing sites and provides that the provisions of the Regulation on Manufacturing Sites for Medicinal Products for Human Use will apply until the new guideline governing manufacturing-site authorisation procedures enters into force.

In addition, the existing compliance period has been extended from two years to five years, thereby lengthening the transitional period available to the sector.

This amendment provides significant practical flexibility, particularly for manufacturers that need to adapt their production infrastructure to the new requirements.

Key Considerations for Companies

The Amendment Regulation is particularly relevant to:

• manufacturers of traditional herbal medicinal products;
• importers;
• marketing authorisation holders;
• pharmaceutical companies operating in the herbal products sector; and
• manufacturers developing products derived from endemic plants.

In this context, companies should:

• reassess their product portfolios in light of the updated definitions;
• analyse whether products with aromatherapeutic characteristics fall within the scope of the new Regulation on Aromatherapeutic Products;
• prepare their marketing authorisation dossiers in accordance with the new criteria;
• assess the availability of applications based on EMA monographs and “well-established use”;
• take account of the new documentation requirements for products derived from endemic plants; and
• review their post-authorisation quality, pharmacovigilance and compliance processes.

Conclusion

The Amendment Regulation significantly modernises the authorisation framework for traditional herbal medicinal products by incorporating enhanced scientific assessment criteria, international practice and sustainability considerations. When considered together with the Regulation on Aromatherapeutic Products, which entered into force on the same date, the regulatory framework for plant-based health products has become more systematic and product-specific.

Companies operating in the sector should therefore review not only their existing and planned marketing authorisation applications, but also their product classifications, manufacturing processes, document-management procedures and post-authorisation compliance mechanisms in light of the new requirements. Early compliance work will support the efficient management of authorisation processes 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.