5.—(1) The applicant must submit data as to the efficacy of the product.U.K.
(2) The data must consist of at least one the following—
(a)study reports in relation to the product;
(b)published scientific literature; or
(c)the results of investigations (commonly known as homoeopathic provings) consisting of the administration of a substance to a human subject to ascertain the symptoms it produces.
(3) The applicant must include with the data—
(a)a table of contents; and
(b)an evaluation of the data, including an explanation of how the data establishes that the product has a recognised level of efficacy in the therapeutic indication for which authorisation is sought.