Requirements for documentation for a marketing authorisation application for homeopathic and anthroposophic preparation
The following Finnish Medicines Agency administrative guidelines contain detailed requirements concerning applications for marketing authorisations for homeopathic and anthroposophic preparations and concerning products that have already been granted an authorisation:
- ‘Applying for and maintaining a marketing authorisation and registration for a medicinal product’, 3/2015
- ‘Labelling and package leaflet for a medicinal product’, 3/2013
These regulations are based on the Medicines Act and Decree.
An administrative section, summaries or expert reports, quality documentation, sufficient documentation to guarantee safety and a report on the homeopathic nature of the product based on a sufficient number of literature references must always be appended in full to the application.
Application forms, CTD forms can be found on the Commission’s website and can also be printed out from the Finnish Medicines Agency website.
The provisions require that the quality and manufacture of each product be detailed separately in all cases, as with other medicinal products (Directive 2003/63/EC).
Documentation on safety and efficacy
a) Products for which an indication is not suggested
- Either the safety of the product must be demonstrated through original studies, or else it must be shown on the basis of published literature that the dilution concerned is safe in relation to the method of administration in question.
- An expert statement on the safety of the product should be presented.
- No specific demonstration of effect is required, but the homeopathic use of the product must be presented e.g. on the basis of the literature.
- Provisions on pharmacovigilance must have been taken into account.
b ) Products for which an indication for use is suggested
- For safety, the same documentation as for products for which an indication is not suggested should be presented.
- Efficacy must be proven as for other medicinal products.
Provisions on pharmacovigilance must also have been taken into account.
The application should be submitted to the Finnish Medicines Agency by post, using the address P.O.Box 55, 00034 FIMEA, or Nauvontie 4, Helsinki. The envelope should be marked “Application for marketing authorisation for a homeopathic and anthroposophic preparation”.