The guidance document Authorisation of herbal medicinal products HMV4 provides applicants with clear information on the requirements that must be fulfilled so that authorisation applications for herbal medicinal products can be processed as quickly and efficiently as possible.
Swissmedic has updated the content of the guidance document based on accumulated experience, particularly with the new requirements stated in the revised Therapeutic Products Act:
- Tables and examples of declaration requirements supplemented (section 5.1.3).
The requirements in this section apply to herbal medicinal products as well as to further medicinal product categories (e.g. anthroposophics), provided a corresponding reference is made in the relevant guidance document. - Explanation of requirements for authorisation applications for fixed-dose combination medicinal products with or without a reference to traditional use (section 9.3).
Some linguistic and content-related clarifications have also been made. These reflect the current Swissmedic practice and are therefore not new requirements.
Please see the guidance document for details.
The new version of the guidance document takes effect on 5 December 2020.