Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (c. 83)

TITLE III U.K. PLACING ON THE MARKET

CHAPTER 2 U.K. Specific provisions applicable to homeopathic medicinal products

Article 15 U.K.

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,

• [F1 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,

• [F1 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.

Textual Amendments

F1 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.