# The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, Regulation 5: Determination of application for certificate


(1) In dealing with an application for a certificate of registration, the licensing authority shall, in respect of any product to which the application relates, take due account of any registration granted by any member State other than the United Kingdom in accordance with Article 7 of Council Directive 92/73/EEC and of any authorisation granted by any such member State in accordance with Article 9 of that Directive.
(2) On an application for a certificate of registration, the licensing authority may grant such a certificate, but shall, subject to paragraph (3) below, refuse to grant such a certificate where—
(a) the product is not for oral or external administration;
(b) a specific therapeutic indication appears on the labelling of the product or in any information relating thereto;
(c) the product does not have a sufficient degree of dilution to guarantee its safety;
(d) after verification of the material and information submitted in accordance with regulation 4(1) of these Regulations, the product proves to be harmful in the normal conditions of use, or the qualitative or quantitative composition of the product is not as declared; or
(e) the application does not comply with regulation 4(1) of these Regulations.
(3) Products shall not be considered to have a sufficient degree of dilution to guarantee their safety where they contain more than —
(a) one part per 10,000 of the mother tincture; or
(b) one hundredth of the smallest dose used in allopathy with regard to active principles whose presence in an allopathic medicinal product would require it to be sold by retail or supplied in circumstances corresponding to retail sale in accordance with a prescription given by a doctor.
(4) The licensing authority shall not refuse to grant a certificate of registration on the ground set out in paragraph (2)(c) or (d) above except after consultation with the Board.
(5) Subject to paragraph (6) below, the licensing authority shall take all appropriate measures to ensure that the procedure for determining an application for a certificate of registration is completed within 120 days of the date of submission of the application by the applicant.
(6) The time limit referred to in paragraph (5) above may be extended for a further 90 days where the applicant is notified that the time is to be so extended, in writing, prior to the expiry of that time limit.

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Source: https://www.legislation.gov.uk/uksi/1994/105/regulation/5 (the official version)
Page: https://openlegislation.uk/medicines-homoeopathic-medicinal-products-for-human-use-regulations-1994/regulation-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.