Homeopathic medicinal products must be registered at the Medical Products Agency in order to be sold on the Swedish market.
Applications for registration
Registration applications for homeopathic medicinal products must be submitted to the Medical Products Agency in English in CTD format (Common Technical Document). A CTD-compliant application form can be downloaded from the European Commission’s website.
The full, original CTD format cannot be directly applied to homeopathic products. Instead, there is a special application form for homeopathic products (EudraLex series ”The Rules Governing Medicinal Products in the European Union”, Notice to applicants, volume 2B, module 1.2 Homeopathic application form).
In addition to the application form and accompanying information from EudraLex, the following code of statutes from the Medical Products Agency contain useful information regarding registration applications for homeopathic products: LVFS 2006:12 Föreskrifter om ändring i Läkemedelsverkets föreskrifter och allmänna råd (LVFS 1997:9) om registrering av vissa homeopatika [in Swedish only, approximate title: “Instructions regarding amendments to the Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products”].
There are also the following guidelines on the Homeopathic Medicinal Products Working Group’s (HMPWG) website:
- Guidance document on Module 3 of the Homeopathic Medicinal Products Dossier
- Points to Consider on non-clinical safety of homeopathic medicinal products of botanical, mineral and chemical origin
- Points to Consider on Safety of Homeopathic Medicinal Products from Biological Origin
- Points to consider on stability testing of homeopathic medicinal products
In summary, application for registering homeopathic medicinal products requires a correctly filled in CTD application containing modules 1, 2 and 3 as well as applicable parts of module 4 (module 5 is not obligatory for homeopathic medicinal products, but ought to be used if clinical information about the product is available).
Labelling
Homeopathic products must be labelled in compliance with Chapter three of LVFS 2006:12 Föreskrifter om ändring i Läkemedelsverkets föreskrifter och allmänna råd (LVFS 1997:9) om registrering av vissa homeopatika [in Swedish only, approximate title: “Instructions regarding amendments to the Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products”].
See Part 3 of the English version of the Medical Products Agency's code of statutes LVFS 2003:2 Instructions regarding amendments to the Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products. The suggested labelling should be submitted in the application for registration.
Revisions and renewals
Variations to the information on which the registration of a homeopathic product is based may only be made with the approval of the Medical Products Agency (see link on the right: LVFS 2006:12). These may include change of manufacturer or supplier, new composition of excipients, changed manufacturing method, revised quality standards and changes in packaging design or size. Applications for variations shall be submitted to the Medical Products Agency together with the requisite documentation for making a decision.
Authorisation to market registered homeopathic medicinal products is valid for five years. To renew authorisation, an application for renewal must be received by the Medical Products Agency at least six months prior to the expiration of the current authorisation licence (i.e. 4.5 years following the most recent authorisation).
For further information see the webpage "Renewals".
Illegal sales
Sale of homeopathic products not registered by the Medical Products Agency is illegal.
Illegal sales may be reported to the Medical Products Agency by letter or via e-mail to the Registrar – see contact information on top of page.