TITLE III

MARKETING
CHAPTER 2

Particular provisions applicable to homeopathic veterinary medicinal products
Article 18
A special, simplified application for 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 nature, on the basis of an adequate bibliography; in the case of homeopathic veterinary medicinal products containing biological substances, a description of the measures taken to ensure the absence of pathogens,
- manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation,
- manufacturing authorization for the medicinal products concerned,
- copies of any registrations or authorizations obtained for the same medicinal products in other Member States,
- one or more mock-ups of the outer packaging and immediate packaging of the medicinal products to be registered,
- data concerning the stability of the medicinal product,
- proposed withdrawal period together with all requisite justification.
Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Inserted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.