{"id":156908,"date":"2026-07-06T17:08:15","date_gmt":"2026-07-06T14:08:15","guid":{"rendered":"https:\/\/paksoy.av.tr\/?p=156908"},"modified":"2026-07-06T17:08:15","modified_gmt":"2026-07-06T14:08:15","slug":"legal-developments-regarding-herbal-medicinal-products-foods-for-special-medical-purposes-and-medical-devices","status":"publish","type":"post","link":"https:\/\/paksoy.av.tr\/en\/2026\/07\/legal-developments-regarding-herbal-medicinal-products-foods-for-special-medical-purposes-and-medical-devices\/","title":{"rendered":"Legal developments regarding herbal medicinal products, foods for special medical purposes and medical devices"},"content":{"rendered":"\n

The Regulation on Aromatherapeutic Products and the Regulation on Medicinal Herbal Teas entered into force upon publication in the Official Gazette dated 2\u00a0July\u00a02026 and numbered 33298. Certain amendments were also made to the Regulation on Licensing of Traditional Herbal Medicinal Products (the \u201cTraditional Herbal Medicinal Products Regulation<\/strong>\u201d) and the Regulation on Licensing of Foods for Special Medical Purposes (the \u201cFoods for Special Medical Purposes Regulation<\/strong>\u201d), which likewise entered into force upon publication in the Official Gazette dated 2\u00a0July\u00a02026 and numbered 33298. Additionally, an amendment was made to the Regulation on Sales, Advertisement and Promotion of Medical Devices (the \u201cMedical Device Sales Regulation<\/strong>\u201d), which entered into force upon publication in the Official Gazette dated 3\u00a0July\u00a02026 and numbered 33299.<\/p>\n

The new regulations and changes introduce comprehensive rules on licensing, sales authorisation, placing on the market, electronic tracking, packaging and promotion of aromatherapeutic products and medicinal herbal teas. The amendment package also includes significant revisions to the existing regulatory frameworks for traditional herbal medicinal products and foods for special medical purposes. These changes introduce substantial new obligations for applicants, licence holders, manufacturers and distribution and sales channels, particularly in relation to licensing, sales channels, electronic tracking, packaging, promotion and transitional periods. As for the amendment to the Medical Device Sales Regulation, this introduces a new restriction on the sale of contact lenses.<\/p>\n

1. Regulation on aromatherapeutic products<\/strong><\/h2>\n

This Regulation establishes the procedures and principles governing the licensing of aromatherapeutic products consisting of essential oils standardised in accordance with pharmacopoeias and monographs, carrier oils, hydrosols and their mixtures. Products intended for internal use are expressly excluded from the scope of the regulation. The regulation applies to both natural persons and legal entities applying for a licence for such products, regardless of whether the products are manufactured industrially or prepared individually (magistral preparations) in pharmacies. Accordingly, a licence must be obtained from the Turkish Medicines and Medical Devices Agency\u2019s (\u201cAgency<\/strong>\u201d) for aromatherapeutic products before they can be placed on the market or used in the magistral preparation of medicines in pharmacies.<\/p>\n

Key developments introduced under the regulation include the following:<\/p>\n

    \n
  • Licence application<\/strong>. Natural person applicants must hold at least an undergraduate degree and be authorised to practise their profession in T\u00fcrkiye. Legal entities must employ a responsible person meeting these qualifications. The application to be submitted to the Agency must include information such as the commercial name of the product, the scientific names of all ingredients, methods of obtaining the ingredients, pharmaceutical form, method of administration, shelf life and storage conditions.<\/li>\n
  • Licensing criteria and process<\/strong>. The products subject to the application must be prepared in accordance with the monographs published by the Agency or otherwise approved by the Agency. The licensing process comprises two stages; following the preliminary assessment, the applicant will be notified as to whether the application has been accepted, although such notification does not commence the licensing process. A separate notification will confirm that the application is complete, at which point the licensing process will be deemed to have commenced. The licensing process is expected to be completed within 60\u00a0days from the date of that notification.<\/li>\n
  • Sales authorisation and placing on the market.<\/strong> In addition to a licence, a separate sales authorisation must be obtained from the Agency for aromatherapeutic products being placed on the market for the first time. Furthermore, the licence holder is obliged to notify the Agency at least 30\u00a0days in advance if they will be unable to place a product on the market for any reason. In addition, all products will be subject to a QR code-based electronic tracking system enabling real-time traceability throughout the supply chain, from production to the end user.<\/li>\n
  • Packaging and product safety.<\/strong> Both the inner and outer packaging must include mandatory information such as the product composition, directions for use, storage conditions, licence and tracking details, and safety warnings. In order to ensure controlled dosage application, products intended for dropper use are required to be placed on the market with an internal dropper bottle and cap system.<\/li>\n
  • Restrictions on product name and promotion.<\/strong> Once the licence has been granted for an aromatherapeutic product, the same product name may not be used for a food supplement, medicinal product for human use, medical device, cosmetic product or medicinal herbal tea. Promotional activities may only be carried out within the pharmacy and strictly in accordance with the intended use approved by the Agency.<\/li>\n<\/ul>\n

    2. Regulation on medicinal herbal teas<\/strong><\/h2>\n

    This regulation establishes a standalone licensing regime for medicinal herbal teas, separating them from the framework applicable to food supplements and general food legislation. The regulation covers tea preparations prepared using pharmacopoeia-quality medicinal plants and the drugs derived from them, whether used individually or in combination, and draws no distinction between industrial manufacture and magistral preparation in pharmacies. Herbal and fruit teas marketed as food products, as well as food supplements, are expressly excluded from the scope of the regulation. Similarly, medicinal herbal teas must be licensed by the Agency to be placed on the market.<\/p>\n

    Some of the key developments introduced under the regulation are as follows:<\/p>\n

      \n
    • Licence application.<\/strong> Consistent with the Regulation on Aromatherapeutic Products, natural person applicants are required to hold at least an undergraduate degree and to be authorised to practise their profession in T\u00fcrkiye; and legal entities are required to employ a responsible person meeting these qualifications.<\/li>\n<\/ul>\n

      The application must include information such as the commercial name of the product, the binomial name and family of the plant, the intended use, method of administration, shelf life and storage conditions, as well as an analysis report demonstrating conformity with the European or Turkish Pharmacopoeia. Where the applicant is not the manufacturer, the application file must also include a contract manufacturing agreement concluded with a manufacturer holding a manufacturing site permit and a pharmacopoeia conformity certificate, as well as a manufacturer\u2019s declaration indicating the Latin name and origin of the plants.<\/p>\n

        \n
      • Licensing criteria and process<\/strong>. For a licence to be granted, the product must be of pharmacopoeia quality and must be found to be satisfactory in terms of efficacy and safety in accordance with the monographs published by the Agency. For drugs derived from endemic plants in T\u00fcrkiye, a scientific data-supported monograph issued by the Agency is additionally required. The licensing process is similarly structured in two stages, and complete applications are expected to be concluded within 90\u00a0days.<\/li>\n
      • Manufacturing, placing on the market and tracking.<\/strong> In facilities producing whole-leaf or bagged teas, medicinal herbal teas must be manufactured in a dedicated production area or packaged on a line exclusively allocated to such products, with raw materials stored separately from other goods. All products must be registered in the Agency\u2019s electronic tracking system and tracked on a unit-by-unit basis. Failure to place at least one commercial batch on the market within 30\u00a0months of obtaining a licence has been regulated as a matter that may result in licence suspension.<\/li>\n
      • Packaging and product name<\/strong>.<\/strong> Information on the packaging must be in Turkish. Products that may impair the ability to drive or operate machinery must bear a triangular warning symbol and the relevant warning statement on the packaging. A licence may not be granted for a product name already registered for a food supplement, cosmetic product, medicinal product, medical device or aromatherapeutic product; similarly, once authorised, the same name may not be used for such products on the market.<\/li>\n
      • Promotion<\/strong>.<\/strong> Promotional activities for medicinal herbal teas may only be carried out within the pharmacy and strictly in accordance with the intended use approved by the Agency.<\/li>\n<\/ul>\n

        3. Amendments to the traditional herbal medicinal products regulation<\/strong><\/h2>\n

        Medicinal herbal teas and aromatherapeutic products have been excluded from the scope of the Traditional Herbal Medicinal Products Regulation, and such products will therefore be subject to separate licensing regimes under their own dedicated regulations as discussed above. Furthermore, the following significant amendments have been introduced:<\/p>\n

          \n
        • Scope of applicants<\/strong>. The categories of persons eligible to apply for licensing have been expanded. While previously limited to graduates in pharmacy, medicine and chemistry, the scope now also includes graduates in agricultural engineering, nutrition and dietetics, biology, molecular biology and genetics, bioengineering, and chemical engineering.<\/li>\n
        • Licence application conditions and well-established use.<\/strong> Traditional herbal medicinal products may now be developed for both prescription and non-prescription use. In demonstrating traditional use, documents recognised by the Agency as having scientific validity, as well as evidence of \u201cwell-established use\u201d, will be accepted. Well-established use is defined as use supported by scientific data demonstrating efficacy and safety for more than 10\u00a0years in EU Member States and\/or T\u00fcrkiye. Applications supported by monographs published by the Agency or the European Medicines Agency (EMA) on traditional use or well-established use will qualify as abridged applications.<\/li>\n
        • Endemic plants<\/strong>.<\/strong> A separate application type has been introduced for drugs and preparations derived from endemic medicinal plants native to the flora of T\u00fcrkiye. Such applications must be supported by additional documentation, including taxonomic registration, a sustainable utilisation plan, a certificate issued by the Ministry of Agriculture and Forestry, and, where applicable, a forestry use permit.<\/li>\n
        • Licence renewal<\/strong> procedure.<\/strong> The previous requirement for submission of a comprehensive application file 9 months prior to expiry of the 5-year licence period has been shortened to at least 3 months. It is now sufficient to submit an updated application file reflecting all changes, including pharmacovigilance data.<\/li>\n
        • Transitional period.<\/strong> For products currently on the market with an intermediate product permit and whose licensing process is ongoing, the envisaged licensing completion period from the date of entry into force of the regulation has been extended from 2 years to 5 years.<\/li>\n<\/ul>\n

          4. Amendments to the foods for special medical purposes regulation<\/strong><\/h2>\n

          Certain amendments have also been made to the Foods for Special Medical Purposes Regulation. Some of the key changes introduced are as follows:<\/p>\n

            \n
          • Pesticide limit.<\/strong> For products intended for infants and young children, the previously applicable aggregate pesticide residue limit of 0.003 mg\/kg (assessed based on all contaminants collectively) has been replaced with a substance-specific approach. Accordingly, the limit of 0.003 mg\/kg now applies individually to each pesticide residue, marking a shift from a total residue threshold to a per-pesticide limit system.<\/li>\n
          • Scientific committee authority.<\/strong> The Agency has been granted explicit authority to establish committees and to seek opinions from scientific advisory committees where it deems necessary during evaluation processes relating to foods for special medical purposes.<\/li>\n
          • Transitional period.<\/strong> The deadline for submitting licence applications for products currently on the market under an import or manufacturing permit has been postponed from 1\u00a0July\u00a02026 to 1\u00a0July\u00a02027. Products may continue to be placed on the market under existing permits until a licence application is submitted, and, for products in respect of which an application has been made, until the licensing process is concluded.<\/li>\n<\/ul>\n

            5. Amendments to medical device sales regulation<\/strong><\/h2>\n

            New restrictions on the online sale of contact lenses have been introduced through the amendments. Accordingly, contact lenses may only be sold through websites authorised by the Agency and subject to prescription requirements. The Agency is also empowered to delegate its authority to grant such website authorisations to Provincial Health Directorates. However, the application procedure for obtaining such authorisations, how authorisations must be displayed on websites, and other implementation details have not yet been regulated. These aspects are expected to be clarified by way of a guideline or amendments to existing guidelines.<\/p>\n","protected":false},"excerpt":{"rendered":"

            The Regulation on Aromatherapeutic Products and the Regulation on Medicinal Herbal Teas, together with the amendments to the Regulation on Licensing of Traditional Herbal Medicinal Products and the Regulation on Licensing of Foods for Special Medical Purposes, entered into force upon publication in the Official Gazette dated 2 July 2026 and numbered 33298; the amendment to the Regulation on Sales, Advertisement and Promotion of Medical Devices entered into force upon publication in the Official Gazette dated 3 July 2026 and numbered 33299.<\/p>\n","protected":false},"author":3,"featured_media":156931,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[281],"tags":[],"class_list":["post-156908","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-publications"],"acf":[],"yoast_head":"\nLegal developments regarding herbal medicinal products, foods for special medical purposes and medical devices | Paksoy Attorneys at Law<\/title>\n<meta name=\"description\" content=\"The Regulation on Aromatherapeutic Products and the Regulation on Medicinal Herbal Teas, together with the amendments to the Regulation on Licensing of Traditional Herbal Medicinal Products and the Regulation on Licensing of Foods for Special Medical Purposes, entered into force upon publication in the Official Gazette dated 2 July 2026 and numbered 33298; 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