Registration of homeopathic medicinal products

Homeopathic medicinal products must be registered at the Swedish 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 Swedish 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 (see EudraLex volume 2).

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 Swedish 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 Swedish 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).

Exceptions to the above requirements can be made if the product is based on raw material included in one of the following lists from HMPWG:

1. List of stocks with justified homeopathic use (HU) – a list of stocks where the homeopathic use is considered justified. For a homeopathic medicinal product based on a stock included in this list, a reference to the list can be made in the application for registration. No additional documentation is required for justification of homeopathic use.

2. List of first safe dilutions (FSD) – a list of raw material where the first safe dilution has been assessed by the HMPWG. For products where the raw material is more dilute than the first safe dilution, a reference to the list can be made. No additional safety documentation is required.

The lists will be updated on a regular basis and will be available on the:

 Homeopathic Medicinal Products Working Group (HMPWG)

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 Swedish 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 Swedish Medical Products Agency's code of statutes LVFS 2003:2 Instructions regarding amendments to the Swedish 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 Swedish 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 Swedish Medical Products Agency together with the requisite documentation for making a decision. For further information see the webpage "Variations".

A renewal application for a homeopathic medicinal product for human use must be received by the MPA at the latest nine months before the end of the five year period (i.e. the renewal date). A renewal application for a veterinary homeopathic medicinal product must be received by the MPA at the latest six months before the end of the five year period (i.e. the renewal date). For further information see the webpage "Renewals".

Illegal sales

Sale of homeopathic products not registered by the Swedish Medical Products Agency is illegal.

Illegal sales may be reported to the Swedish Medical Products Agency by letter or via e-mail to the Registrar – see contact information on top of page.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information