The applicable laws and provisional regulations for homeopathy

Manufacture, import, marketing

The manufacture and import of homeopathic medicinal products are subject to the same regulations as other medicinal products (see Laws and Statutes below). Wholesale distribution of homeopathic medicinal products may only be undertaken by those authorised by the Swedish Medical Products Agency. Registered homeopathic products may be freely sold by retailers.

Laws and Statutes

The laws and statutes which regulate manufacture, import and trade with homeopathic medicinal products in Sweden:

  • SFS 2015:315 Läkemedelslagen [In Swedish only; standard English title: “Medicinal Products Act”]
  • LVFS 2004:7 Läkemedelsverkets föreskrifter och allmänna råd om tillstånd för tillverkning och import av läkemedel [In Swedish only; approximate English title: “The Swedish Medical Products Agency’s provisions and guidelines for marketing authorisation to manufacture and import medicinal products”]
  • LVFS 2003:2 Föreskrifter om ändring i Läkemedelsverkets föreskrifter och allmänna råd (LVFS 1997:9) om registrering av vissa homeopatika [”Instructions regarding amendments to the Swedish Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products”] Available in English, se Related information on the right. 
  • LVFS 2000:9 Läkemedelsverkets föreskrifter och allmänna råd om erläggande av ansöknings- och årsavgifter för läkemedel [In Swedish only; approximate English title: “The Swedish Medical Products Agency’s provisions and guidelines concerning the payment of application and annual fees for medicinal products ”]
  • LVFS 1997:3 Läkemedelsverkets föreskrifter om tillstånd för partihandel med läkemedel [In Swedish only; approximate English title: “the Swedish Medical Products Agency’s provisions on authorization for the wholesale trade of medicinal products]
  • LVFS 2006:8 Föreskrifter om ändring i Läkemedelsverkets föreskrifter och allmänna råd (LVFS 2004:7) om tillstånd för tillverkning och import av läkemedel [in Swedish only; approximate English Title: ”Provisions on the revision of the Swedish Medical Products Agency’s provisions and guidelines (LVFS 2004:7) concerning authorisation to manufacture and import medicinal 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 English title: ”Instructions regarding amendments to the Swedish Medical Products Agency’s provisions and guidelines (LVFS 1997:9) on the registration of certain homeopathic products”]
  • Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use 
  • Directive 2001/82/EC of the European Parliament and of the Council on the Community Code Relating to Veterinary Medicinal Products

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.

 

 

 
 
 

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