A homoeopathic medicinal product is defined in European legislation (Article 1 Directive 2001/83/EC as amended) as:

"Any medicinal product prepared from substances called homeopathic stocks in accordance  with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles".

Homeopathic Medicinal products are distinct from other types of medicines, such as herbal medicinal products or pharmaceutical products, although they can be prepared from these sources. This distinction comes from the methods used in their preparation as well as the principles on which they are prescribed.

Preparation of homeopathic medicines involves the use of minute amounts of substances, which are dissolved, further diluted and mixed in a manner designed to activate their healing potential, while concomitantly eliminating side effects; which would arise from using the original substances.

The authorization of homeopathic medicinal products is based on Directive 2001/83/EC as amended  and Directive 2003/63/EC. Taking into account the unique nature of homeopathic medicines, (high dilution factor),  Directive 2001/38EC as amended makes provision for a simplified registration procedure for homeopathic medicinal products for human use, to be implemented in Member States. The directive outlines the criteria that must be satisfied in order for a homeopathic medicinal product to be eligible for registration. The articles relevant to homeopathic medicinal products include articles 13 - 16, 68 and 69 of Directive 2001/83/EC as amended.

To-date articles 13 and 14 of Directive 2001/83/EC, as amended, have been implemented into the national legislation as per article 32 of the Medicines Act 2003 , as amended.  Other relevant articles will be published in the amended Medicines (Marketing Authorisation) Regulations.  Guidelines will also be issued explaining the system for registration.

The Homeopathic application form that will be used for the simple registration system has been published in December 2005 in the Notice to Applicants:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/applicformhomeo_2005_12.doc or http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/applicformhomeo_2005_12.pdf

 You may also find a user guide on how to complete the application form:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/part1a_userguide_03-2005.pdf