The Guidance document Authorisation of herbal medicinal products provides applicants with clear information on the requirements that must be fulfilled so that authorisation applications for herbal medicinal products in both the regular and simplified procedures can be processed as quickly and efficiently as possible.
Swissmedic has updated the content of the Guidance document based on accumulated experience. The main changes are clarifications regarding definitions and description of the existing requirements. The unchanged legal requirements (particularly TPA, KPTPO) are better described.
- The information in the various sections has been restructured, making it easier to find.
- The definitions of comparator medicinal products and reference medicinal products have been designed specifically for the simplified authorisation of herbal medicinal products.
- Additions have been made to the section on the requirements for the declaration, which now includes taking into account the declaration of standardised dry extracts, among other things.
- The KPTPO requirements regarding evidence of tolerability for herbal medicinal products in the simplified authorisation procedure have been incorporated into the Guidance document.
- The simplified procedure definitions of “herbal medicinal product with well-established use” and “herbal medicinal product with traditional use” have been clarified based on KPTPO.
- The requirements on evidence of comparability of two herbal medicinal products have been specified in greater detail.
- Annex 1 includes references to current guidelines.
- The summary of requirements formerly provided as a list has been replaced by a summary table in Annex 2.
Please see the Guidance document for details.
The new version of the Guidance document Authorisation of herbal medicinal products takes effect on 1 March 2025.