Application for registration
64.—(1) An applicant for registration must submit the following to the Secretary of State—
(a)the scientific name or other name of the homeopathic stock given in a pharmacopoeia, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution;
(b)a dossier describing how the homeopathic stock is obtained and controlled, and justifying its homeopathic nature, on the basis of an adequate bibliography;
(c)in the case of a product containing biological substances, a description of the measures taken to ensure the absence of pathogens;
(d)the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;
(e)a copy of the manufacturing authorisation for the product;
(f)copies of any registrations or authorisations obtained for the same homeopathic remedy in other member States;
(g)a mock-up of the outer packaging and immediate packaging;
(h)stability data;
(i)the proposed withdrawal period necessary to ensure that the provisions of Council Regulation (EEC) No. 2377/90 are complied with together with all necessary justification.
(2) These documents must demonstrate the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned.
(3) In the case of a food-producing animal, if the applicant states in the application that the homeopathic remedy contains an active substance, or has been manufactured using an active substance, that substance must be one that appears in Annex II to Regulation (EEC) No. 2377/90 and complies with any requirements in that Annex relating to that substance.
(4) If a product is registered in another member State, the Secretary of State may waive some or all of the requirements of this paragraph if he is satisfied that it is reasonable to do so.