The Human Medicines Regulations 2012

Regulations 50(6)(g) and 64(5)(b)

SCHEDULE 10 National homoeopathic products

Meaning of “national homoeopathic product”

1.—(1) In this Schedule “national homoeopathic product” means a homoeopathic medicinal product that—

(a) is not a registrable homoeopathic medicinal product; and

(b) is indicated for the relief or treatment of minor symptoms or minor conditions in human beings.

(2) For this purpose symptoms or conditions are minor if they can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

General requirements for application

2.—(1) An application for the grant of a UK marketing authorisation for a national homoeopathic product does not need be made in accordance with, and an applicant for such an authorisation does not need to comply with—

(a) paragraphs (b) and (c) of paragraph 10 of Schedule 8 (requirement to submit results of pre-clinical tests and clinical trials);

(b) the guidance referred to in paragraph (1) in the “Introduction and general principles” of Annex 1 to the 2001 Directive in so far as it relates to the requirement to submit the results of pre-clinical tests and clinical trials; or

(c) the following provisions of Part 1 of that Annex—

(i) sections 2.4 to 2.7 (non-clinical and clinical overview and non-clinical and clinical summaries),

(ii) section 4 (Module 4: non-clinical reports), or

(iii) section 5 (Module 5: clinical study reports).

(2) The applicant must submit with the application—

(a) particulars and documents relating to the safety of the product in accordance with paragraph 3 (subject to paragraph 4); and

(b) particulars and documents relating to the efficacy of the product in accordance with paragraph 5.

(3) References in Annex 1 to the 2001 Directive to non-clinical reports, non-clinical documentation and non-clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 3.

(4) References in that Annex to clinical study reports, clinical documentation and clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 5.

Requirement to submit safety data

3.—(1) The applicant must submit data as to the safety of the product unless paragraph 4 applies.

(2) The data must include information about the following aspects of the safety of the product—

(a) pharmacology;

(b) pharmacokinetics; and

(c) toxicology, including its toxicity, genotoxicity, reproductive and developmental toxicity and local tolerance.

(3) The data must be scientific data unless sub-paragraph (5) applies.

(4) For this purpose “scientific data” means—

(a) study reports in relation to the product;

(b) published scientific data; or

(c) a combination of data within paragraph (a) and data within paragraph (b).

(5) The applicant may submit other data in relation to an aspect of the safety of the product if having made reasonable attempts to obtain scientific data in relation to that aspect—

(a) the applicant is satisfied that no such scientific data is available; or

(b) the applicant thinks that such scientific data as is available may be inadequate to demonstrate an acceptable level of safety in relation to that aspect.

(6) The applicant must include with the data—

(a) a table of contents; and

(b) an evaluation of the scientific data, including an explanation of how it demonstrates an acceptable level of safety.

(7) If the applicant submits data other than scientific data, the applicant must include—

(a) a statement that sub-paragraph (5) applies; and

(b) an explanation of why an acceptable level of safety can be demonstrated despite the lack of scientific data.

Exceptions to requirement to submit safety data

4.—(1) The applicant does not need to submit data as to the safety of the product if—

(a) condition A, B or C is met; and

(b) the application is accompanied by a written statement that the condition is met.

(2) Condition A is that the product—

(a) is derived from a homoeopathic stock that is commonly present in food; and

(b) is intended to be administered orally.

(3) For this purpose “food” has the meaning given by Council Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1).

(4) Condition B is that—

(a) the product is derived from a homoeopathic stock from which is derived a medicinal product that has a marketing authorisation, certificate of registration or traditional herbal registration (“the source product”);

(b) the source product is subject to general sale within the meaning of regulation 5(1); and

(c) the product has the same route of administration and the same degree of dilution as the source product.

(5) Condition C is that the product is derived from a homoeopathic stock that—

(a) is diluted to at least 1 in 10²⁴ of the stock; and

(b) is not a material derived from a human or animal source.

Requirement to submit efficacy data

5.—(1) The applicant must submit data as to the efficacy of the product.

(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.

(1)

OJ No L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p. 14).