The Guidance document Authorisation of homeopathics, anthroposophics and other complementary medicinal products 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:
- Additional section inserted on "Further requirements" for the Full declaration form (section 5.3.1.4) and the declaration in Packaging and patient information (section 5.3.2.4). Requirements supplemented and clarified in these sections.
- Requirements changed for stating the drop equivalent for eyedrops (sections 5.3.1.4, 5.3.2.4, 7.2.3 and 9.2)
- Requirement clarified for the listing of sodium-containing excipients (sections 5.3.1.3, 5.3.1.4 and 5.3.2.3)
- Section inserted on "Medicinal product name" (section 6.2), with clarification concerning the inclusion of an indication or mother tincture in the medicinal product name
- Section on the quality of the active substance moved and revised (section 6.4.1)
- Addition concerning packaging texts for medicinal products with indication for medicine cabinets (section 6.7.1.)
- Requirements clarified for the listing of the standard text concerning the indication (section 6.7.2)
Some wording has been changed to reflect the current Swissmedic practice and is to be used consistently in future.
Please see the guidance document for details.
The new version of the guidance document takes effect on 15 June 2023.