S.L. 458.34 Art. 10Specificprovisions applicable to homeopathic medicinal products.

(1) The Authority shall ensure that homeopathic medicinal products manufactured and placed on the market within the

Community are registered or authorised in accordance with this regulation and regulation 11. In case of registrations, regulation

22(1)(a) to (f) shall apply.

(2) The Authority shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in subregulation (3).

(3) Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:

(a) they are administered orally or externally;

(b) no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto;

(c) there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more then one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription. The classification for the dispensing of the medicinal product, shall be determined by the Authority at the time of registration. The criteria and rules of procedure provided for in regulations 12, 17, 18, 19, 20 and 21, and Articles 4(4), 112, 116 and 125 of Directive 2001/83/EC, as amended, shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products with the exception of the proof of therapeutic efficacy.

(4) An application for special, simplified registration may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned:

(a) scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;

(b) dossier describing how any homeopathic stock or stocks is obtained and controlled, and justifying its homeopathic use, on the basis of an adequate bibliography;

(c) manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization;

(d) manufacturing authorisation for the medicinal product concerned;

(e) copies of any registrations or authorisations obtained for the same medicinal product in other Member States;

(f) one or more mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered;

(g) data concerning the stability of the medicinal product.