The Regulation Amending the Regulation on Marketing Authorization of Traditional Herbal Medicinal Products Has Been Published

The Regulation Amending the Regulation on Marketing Authorization of Traditional Herbal Medicinal Products (“Amending Regulation”) was published in the Official Gazette 32741 dated 3 December 2024 entering into effect the same day.

The Amending Regulation provides certain amendments to the Marketing Authorization of Traditional Herbal Medicinal Products (“Regulation”), that was entered into force upon its publication in the Official Gazette 32093 dated 3 February 2024.

The important headings of the Amending Regulation are as follows:

• ▪️ Among the information required to be submitted in the marketing authorization application is a description of the control methods used by the manufacturer. If deemed appropriate by the Turkish Medicines and Medical Devices Agency (‘Agency’), an exception has been added that some of these analyses, tests and controls listed on a product basis may be waived, provided that they do not affect quality, efficacy and safety.
• ▪️ In the marketing authorization application, if the traditional herbal medicinal product manufactured or to be manufactured in Turkey is subject to joint marketing, a joint marketing agreement containing the written approvals of the real persons or commercial companies for joint marketing and the trade registry certificates of the parties have been required to be submitted.
• ▪️ In the marketing authorization application, if the active substance is supplied in Turkey, the supply contract and invoice signed between the active substance supplier and the marketing authorization applicant, and if it is supplied from abroad, a letter of conformity issued in accordance with the relevant guideline published by the Agency must be submitted.
• ▪️ The information and documents to be submitted to the Agency must be deemed appropriate by the Agency in terms of current scientific requirements and the date given for the information and documents to be submitted to the Agency must not exceed three years in total. If the required information and documents are not submitted to the Agency at the end of the specified period, the application will be rejected procedurally.
• ▪️ In case of a new marketing authorization application, the current file reflecting the changes approved or requested by the Authority and the commitment that the changes have been reflected are submitted in the file. If it is determined that the changes approved and requested by the Agency are not reflected in the current file despite this commitment, the file will be rejected again and the priority decisions made by the Priority Evaluation Board for the product in question in the licensing or inspection processes will be cancelled.
• ▪️ During the evaluation process of the application made to the Agency for the authorization of a traditional herbal medicinal product, the applicant will be granted five written response rights. For two of these response rights, if the applicant requests, the written response can also be made as an oral presentation.
• ▪️ The article stating that the traditional herbal medicinal product for which a marketing authorization is applied will be subject to analysis has been removed and laboratory tests have been removed from the minimum requirements for the evaluation of the application. With the added provisional article, the process regarding the traditional herbal medicinal products for which analyses are still in progress is regulated.
• ▪️ The list of traditional herbal medicinal products authorized by the Agency will be announced at least once a month on the official website of the Agency and once a year in the Official Gazette.
• The process of renewal of the marketing authorization has been introduced:
• ▪️ The assessment for renewal of the marketing authorization is made by the Agency five years after the date of grant, taking into account the benefit/risk balance. In accordance with the provisions of the Regulation on the Safety of Medicinal Products, the marketing authorization holder must submit to the Agency nine months before the expiry of the five-year period a dossier containing all current information on efficacy, safety and quality, including the evaluation of suspected adverse reaction reports and periodic benefit/risk assessment reports, and information on all variations made since the product was authorized.
• ▪️ Once the marketing authorization has been renewed, the marketing authorization is valid indefinitely unless the Agency decides to conduct an additional five-year renewal assessment for pharmacovigilance-related reasons, including insufficient patient exposure to the relevant traditional herbal medicinal product.
• ▪️ In cases where five years of pharmacovigilance data for the product cannot be submitted because it has not been placed on the market, the assessment of the validity of the marketing authorization shall be made after the available pharmacovigilance data are prepared and submitted in accordance with the provisions of the relevant legislation.

• ▪️ The scope and duration of the extension of the suspension period of suspended marketing authorizations have been extended and it is regulated that the suspension period can be extended up to 30 months in certain cases.
• ▪️ In case of serious supply problems, the Agency may, upon the request of the marketing authorization holder, allow a licensed traditional herbal medicinal product to be placed on the market in limited quantities for a limited period of time in order to ensure the sustainability of healthcare services.
• ▪️ The scope of the Regulation has been narrowed by changing the references made to “legal entities” to “commercial companies”.
• ▪️ The provision that transfer cannot be established for traditional herbal medicinal products for which no renewal of the marketing authorization has been made has been added and the effective date has been set as 1 July 2025.
• ▪️ The effective date of Article 8(m)(2) and 8(m)(3) of Regulation regarding the documents to be requested by the competent authorities in case clinical trials are conducted abroad has been set as 1 January 2026.

The full text of the Amending Regulation can be reached through this link. (Only Available in Turkish)