Exemption for medicinal products at high dilutions

10.— [F1 (1)] [F2 A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is] a medicinal product which is not for parenteral administration and which consists of or contains, any of the substances listed in column 1 of Schedule 1 [F3 or in Schedule 2], only one or more unit preparation of such substances, if–

(a) each such unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required; or

(b) each such unit preparation has been diluted to at least one part in a million million (6c).

[F4 (2) [F2 A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is] a medicinal product which is not for parenteral administration and which consists of or contains solely one or more unit preparations of the following substances—

• Aconite

• Arsenic Trioxide

• Belladonna Herb

• Ignatia Bean

• Nux Vomica Seed,

if each such unit preparation has been diluted to at least one part in a million (6x)]

Textual Amendments

F1 Art. 10 renumbered as art. 10(1) (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9

F2 Words in art. 10(1)(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(4) (with Sch. 32)

F3 Words in art. 10(1) substituted (1.5.2006) by The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 8

F4 Art. 10(2) inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 9