# The Veterinary Medicines Regulations 2013, Paragraph 64: Application for registration

Extent: E+W+S

(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 or stocks 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 , or stocks are, obtained and controlled, and justifying their homeopathic use, 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 ... obtained for the same homeopathic remedy...;
(g) the text which is to appear on the package leaflet, outer packaging and immediate packaging of the homeopathic remedy;
(h) any relevant data concerning the stability of the homeopathic remedy;
(i) the proposed withdrawal period necessary to ensure that the provisions of Regulation (EC) No 470/2009 of the European Parliament and of the Council 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 for which a maximum residue limit has been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council.
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---
Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/64 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-64
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.