S.L. 437.47 Art. 18Simplified application for registration.

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:

(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 has been obtained and is controlled, and justifying its 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,

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

(d) manufacturing authorisation for the medicinal products concerned,

(e) copies of any registrations or authorisations obtained for the same medicinal products in Member States,

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

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

(h) proposed withdrawal period together with all requisite justification.