New Regulations on Herbal Medicinal Teas and Aromatherapeutic Products Published
The Regulation on Herbal Medicinal Teas (Herbal Medicinal Teas Regulation) and the Regulation on Aromatherapeutic Products (Aromatherapeutic Products Regulation) published in the Official Gazette dated 2 July 2026 and numbered 33298, establish the procedures and principles governing the marketing authorisation of the product categories falling within their scope by the Turkish Medicines and Medical Devices Agency (TITCK). The Regulations also govern the marketing authorisation process, manufacturing and quality standards, market access requirements and the obligations of marketing authorisation holders in relation to those products.
The key changes introduced by the Regulations are summarised below:
Aromatherapeutic Products
- A dedicated marketing authorisation regime has been introduced for aromatherapeutic products. The Aromatherapeutic Products Regulation applies to pharmacopoeia-grade essential and fixed oils, as well as aromatherapeutic products prepared in accordance with TITCK monographs, while excluding cosmetic products, food supplements, medical devices, traditional herbal medicinal products and products containing essential oils placed on the market as food.
- The Aromatherapeutic Products Regulation introduces detailed technical and scientific requirements for marketing authorisation applications. Applications must be supported by technical and scientific documentation demonstrating the quality, safety and efficacy of the product, together with information relating to pharmacopoeial compliance, manufacturing and quality control processes and, where applicable, pre-clinical and clinical studies, all of which must be submitted to TITCK.
- The rules governing market access, distribution and product traceability have been introduced. Accordingly, aromatherapeutic products may only be placed on the market through pharmacies, and a sales authorisation must be obtained prior to their initial placement on the market. The Regulation also establishes the framework for the registration of products within the electronic tracking system through QR codes and their traceability throughout the supply chain.
- The post-authorisation regime has been comprehensively regulated. Accordingly, the Aromatherapeutic Products Regulation sets out the procedures governing marketing authorisation transfers, variation applications and sales authorisation procedures, while also imposing obligations on marketing authorisation holders to maintain the accuracy of product information and ensure ongoing compliance with the applicable legislation. It further regulates the procedures governing the enforcement measures applicable in cases of non-compliance with those obligations.
Herbal Medicinal Teas
- A dedicated marketing authorisation regime has been introduced for herbal medicinal teas. Under the Herbal Medicinal Teas Regulation, herbal medicinal teas intended to be sold exclusively through pharmacies are subject to marketing authorisation by TITCK, while food supplements and herbal or fruit teas placed on the market as food products remain outside its scope.
- The marketing authorisation application process has been comprehensively regulated. Applications must be submitted electronically and supported by technical and scientific documentation based on technical and scientific data demonstrating the quality, safety and efficacy of the product. They must also include comprehensive documentation relating to pharmacopoeial compliance, manufacturing and quality control processes as part of the application dossier.
- Rules governing product traceability have been introduced. Under the Herbal Medicinal Teas Regulation, herbal medicinal teas must be registered within the electronic tracking system through QR codes and be traceable from the manufacturing stage through to pharmacies. The Regulation also sets out the procedures governing these processes, together with the information and warnings to be included on the inner and outer packaging and the requirements relating to the implementation of QR codes.
- The post-authorisation obligations of marketing authorisation holders and the applicable enforcement regime have been regulated. The Herbal Medicinal Teas Regulation imposes obligations on marketing authorisation holders to maintain up-to-date product information and fulfil their post-authorisation obligations, while also setting out the procedures governing the enforcement measures applicable in cases of non-compliance with those obligations.
The Regulations entered into force on 2 July 2026 and apply to the marketing authorisation and placing on the market of the relevant product categories as of that date.
The full texts of the Regulations are available here and here.
All rights of this article are reserved. This article may not be used, reproduced, copied, published, distributed, or otherwise disseminated without quotation or Erdem & Erdem Law Firm's written consent. Any content created without citing the resource or Erdem & Erdem Law Firm’s written consent is regularly tracked, and legal action will be taken in case of violation.
Other Contents
Pursuant to the Communiqué on Amendments to the Social Security Institution Health Implementation Communiqué (the Communiqué) published in the Official Gazette dated 29 June 2026 and numbered 33295, and the Decisions of the Health Services Pricing…
Through the Communiqué on Amendments to the Social Security Institution Health Implementation Communiqué (the Communiqué), published in the Official Gazette dated May 23, 2026, and numbered 33262, significant amendments have been introduced to the…