- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
The Ministerial Order of 3 October 1973  established a special registration for medicinal plants. Products (1) consisting exclusively of whole, comminuted or powdered medicinal plants or parts thereof have to be registered. Preparations (2) containing a single species or parts thereof which are included in a special list as annex to this order, are exempted and do not need registration.
Medicinal plants with or without obligation for registration (1 and 2) can be controlled by the health authority. For registration of medicinal plants (1), pharmacological and analytical documentation has to be presented including indications, dosage, and the analytical methods. For plants which are not yet included in the list, it is possible to apply for their inclusion .
Preparations containing extracts, tinctures, distillates etc., and other galenical preparations, are regarded as medicines which have to fulfil all the requirements of the Spanish Drug Law .