The Human Medicines Regulations 2012

Application of Part

102.—(1) This Part applies to a homoeopathic medicinal product (a “registrable homoeopathic medicinal product”) that meets the following conditions.

(2) Condition A is that the product is administered orally or externally.

(3) Condition B is that no specific therapeutic indication appears—

(a) on the labelling of the product; or

(b) in any information supplied with the product.

(4) Condition C is that—

(a) the product contains no more than one part per 10,000 of the mother tincture; and

(b) in a case where the product’s active substance is a relevant allopathic substance, the product contains no more than 1/100th of the smallest concentration of that substance used in allopathy.

(5) In this regulation “relevant allopathic substance” means an active substance whose presence in an allopathic medicinal product means that the product is only available on prescription.

(6) For this purpose—

(a) “allopathic medicinal product” means a medicinal product other than a homoeopathic medicinal product; and

(b) “allopathy” means treatment using an allopathic medicinal product.