Article 10 Exemption for medicinal products at high dilutions

F1(1)

F2A 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 F3or 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)

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)

Annotations

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