The Guidance document ‘Authorisation of homeopathics, anthroposophics and other complementary medicinal products HMV4’ clearly sets out the requirements that must be fulfilled by applicants so that authorisation applications for complementary medicines used in alternative treatments (e.g. homeopathy, spagyrics, Schüssler therapy, gemmotherapy, anthroposophy, excluding Asian schools of therapy) 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 and related ordinances:
- Declaration requirements structured according to the type of treatments (section 5.3).
Examples added to the declaration requirements for spagyric medicinal products (sections 188.8.131.52.1 and 184.108.40.206.1) and for medicinal products for gemmotherapy (sections 220.127.116.11.3 and 18.104.22.168.3).
Declaration requirements for anthroposophics supplemented and clarified (sections 22.214.171.124, 126.96.36.199 and 7.2.3).
- Requirements added concerning the sodium content and equivalent on the packaging texts (section 188.8.131.52).
- Clarification of the indication-related information (section 6.6.1).
- Clarification of the requirements for the ethanol warning for medicinal products without an indication (section 7.2.3).
- Additional information on the wrap-around labels for medicinal products without an indication (section 7.2.3).
- Examples added relating to declaration on the Full declaration form, medicinal product information and the packaging texts (section 9.2).
Some wording has been changed and content-related clarifications made. These reflect the current Swissmedic practice and are to be used consistently in future.
Please see the guidance document for details.
The new version of the guidance document takes effect on 1 may 2021.