TITLE III

PLACING ON THE MARKET
CHAPTER 2

Specific provisions applicable to homeopathic medicinal products
Article 13
1
Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply.
2
Member States shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in Article 14.
Article 14
1
Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:
- they are administered orally or externally,
- no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto,
- 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 than 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 Commission is empowered to adopt delegated acts in accordance with Article 121a amending the third indent of the first subparagraph if new scientific evidence so warrants.
At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product.
2
The criteria and rules of procedure provided for in Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and 125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy.
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Article 15
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:
- 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,
- dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic use, on the basis of an adequate bibliography,
- manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization,
- manufacturing authorization for the medicinal product concerned,
- copies of any registrations or authorizations obtained for the same medicinal product in other Member States,
- one or more mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered,
- data concerning the stability of the medicinal product.
Article 16
1
Homeopathic medicinal products other than those referred to in Article 14(1) shall be authorized and labelled in accordance with Articles 8, 10, 10a, 10b, 10c and 11.
2
A Member State may introduce or retain in its territory specific rules for the preclinical tests and clinical trials of homeopathic medicinal products other than those referred to in Article 14(1) in accordance with the principles and characteristics of homeopathy as practised in that Member State.
In this case, the Member State concerned shall notify the Commission of the specific rules in force.
3
Title IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1).
Deleted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Substituted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).