- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
A new regulation for herbal medicines was published 1 April 1994 by the Ministry of Health , according to which, herbal medicines are medicines which contain as active ingredients only plants or preparations of plants. The regulation does not apply to plant products used in food or beverages and which are regulated as such, unless indication claims are made or they are advertised as medicines, in which case they are regarded as medicines and have to fulfil the requirements of the regulation.
The regulation contains a detailed description of the requirements of the dossier which comply with the European legislation. The dossier has to be submitted to the National Pharmaceutical Office (EOF) which will grant or reject the registration. Furthermore, there are detailed instructions for the content of the package leaflet and labelling .