6. Special cases in marketing authorisations:Homeopathic medicines

1. Homeopathic medicines

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While homeopathic preparations are not regarded akin to other medicines for treating a condition, homeopathy is established to varying degrees as an alternative medicinal field in numerous countries. In some countries, there is no specific legal framework covering the use of homeopathy, while in others, licenses are required. In the EU, Directive 2001/83/EC, provides a harmonised approach to the regulatory handling of these products. According to Article 13 of that Directive, Member States have to ensure that homeopathic medicines placed on the market within the Union are either registered according to Articles 14 and 15 or authorised according to Article 16 of that directive.

2. Definition

1. Definiton

A homeopathic medicine is defined as:

• Any medicine prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or by the pharmacopoeias currently used in the member states.

2. A homeopathic medicine may contain a number of principles

3. Simplified registration procedure

Based on the particular characteristics of homeopathic medicines, such as the very low level of active principles they contain and the difficulty to submit them to the regulatory requirements of conventional medicines, a special, simplified registration procedure was established by the member states for those homeopathic medicines which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient^[1].

Only homeopathic medicines which satisfy all of the following conditions may be subject to this procedure:

• they are administered orally or externally;
• no specific therapeutic indication appears on the labelling or in any relating information;
• there is a sufficient degree of dilution to guarantee the safety^[2] of the medicine*;
• documents are provided as set up by Article 15 of Directive 2001/83/EC in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned

*See also: ‘Points to consider on non-clinical safety of homeopathic medicines of botanical, mineral and chemical origin’ (2007)

4. Labelling

Homeopathic medicinal products must be labelled in accordance with title V of Directive 2001/83/EC (‘on the labelling and package leaflet’), and be identified by the clear mention of ‘homeopathic medicinal product’ on their label. Beyond this, Article 69 of Directive 2001/83/EC stipulates that the labelling and, where appropriate, the package leaflet for homeopathic medicinal products authorised under the simplified registration procedure must bear no other information than that listed in Article 69 of that Directive. In particular, for these medicines the list contains the statement ‘homeopathic medicinal product without approved therapeutic indications’.

Legal basis: Articles 13 to 16; 68, 69 of Directive 2001/83/EC