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.