legislation

The authorisation of homeopathic medicinal products is based on Directive 2001/83/EC of the European Parliament and of the Council of 31 March 2004, and the Dutch Medicines Act (Geneesmiddelenwet). The quality and safety of authorised homeopathic medicinal products must comply with European regulations for medicinal products and with the standards of the European Pharmacopoeia.

A distinction is made between two groups of homeopathic medicinal products:

• when a homeopathic medicinal product is intended for oral or external use, no specific therapeutic indication is stated, and there is a sufficient degree of dilution to guarantee the safety of the product (more diluted than a 1:10,000 dilution of the mother tincture), marketing authorisation must be applied for on the basis of article 42, clause three, of the Medicines Act. This "simplified procedure" is based on the European Directive and is applicable in all 27 member states of the European Union. Only the pharmaceutical quality and the safety of the product are assessed. These homeopathic medicinal products are used by homeopathic practitioners on the basis of the homeopathic Similia principle and are therefore not used for a particular indication. See  Database of Human Medicines.
  
• all other homeopathic medicinal products that do not comply with the criteria for the above-mentioned "simplified procedure" fall under article 42, clause four, of the Medicines Act. These include homeopathic tinctures and dilutions below the 1:10,000 limit, homeopathic products that are not intended for oral or external use and those that are marketed for a particular indication as over-the-counter products. See  Database of Human Medicines.