Requirements for an application for registration for homeopathic and anthroposophic preparation
The following Finnish Medicines Agency administrative guidelines contain detailed requirements concerning applications for a registration 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 guidelines are based on the Medicines Act and Decree.
An administrative section, quality documentation and a report on the homeopathic or anthroposophic 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.
If the product is on the market in an EU country, the marketing authorisation can also be applied for using the mutual recognition procedure. In this case, one should first contact the pharmaceutical authorities of the EU country in question, who will initiate the mutual recognition procedure (Finnish Medicines Agency administrative regulation 3/2015, item 6.3.3).
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).
The homeopathic use of the product must be presented e.g. on the basis of literature.
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.
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 registration for a homeopathic and anthroposophic preparation”