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Safety limits for medicinal products containing estragole have been revised: actions required from marketing authorisation and registration holders
The Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) has published a revised Public Statement on the use of herbal medicinal products containing estragole with related guidance values on safety limits. The guidance values on safety limits are applicable for all medicinal products that contain or may contain estragole. Estragole is a genotoxic carcinogen. The most important estragole sources in medicinal products are fennel and fennel oil, aniseed, anise oil, star anise and star anise oil.
After consulting the Committee for Medicinal Products for Human Use (CHMP), the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) issued a press release in February 2022 containing instructions concerning the assessment of estragole in medicinal products. For the submission of these assessment reports, the two-year period set by the CMDh ended in March 2024.
Each marketing authorisation holder (MAH) / registration holder (RH) must check whether their medicinal products comply with the guidance value for estragole. If necessary, appropriate regulatory action should be undertaken. Excipients should be replaced if possible. The MAH/RH should justify if replacement of these excipients is not considered possible.
Changes in the composition (excipients) of the finished product fall under category B.II.a.3 of the Variation Classification Guideline. If the estragole containing excipient is a flavouring agent, a variation type IA is required, for excipients with other functions, a variation type IB is required to replace or reduce these excipients. Changes in the specification parameters and/or limits of an excipient fall under category B.II.c.1, for example B.II.c.1 f) “as a result of a safety issue” (type IB).
In addition to what is stated above, the marketing authorisation holder / registration holder must perform a product-specific risk assessment concerning estragole in its medicinal product. The risk assessment, together with its conclusions and justification, are to be submitted to Fimea by e-mail to [email protected] by 31 July 2024. The message heading “Estragole” must be used.
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- Jaana Hautala, Senior Researcher, t. +358 (0) 29 522 3411
- Heikki Kartimo, Coordinator for Marketing Authorisations, t. +358 (0) 29 522 3347
- The email takes the form [email protected]