# The Human Medicines Regulations 2012, Regulation 251: Compliance with standards specified in certain publications


(1) A person may not sell a medicinal product that has been demanded by the purchaser by, or by express reference to, a particular name if—
(a) the name is a name at the head of the relevant monograph; and
(b) the product does not comply with the standard specified in that monograph.
(2) A person may not sell or supply a medicinal product in pursuance of a prescription given by a doctor or dentist in which the product required is described by, or by express reference to, a particular name if—
(a) the name is a name at the head of the relevant monograph; and
(b) the product does not comply with the standard specified in that monograph.
(3) A person may not sell or supply a medicinal product that has been offered or exposed for sale by, or by express reference to, a particular name if—
(a) the name is a name at the head of the relevant monograph; and
(b) the product does not comply with the standard specified in that monograph.
(4) If the particular name referred to in paragraph (1), (2) or (3) is that of an active ingredient of the product, the product does not comply with the standard specified in the relevant monograph if, in so far as it consists of that ingredient, it does not comply with that standard.
(5) See regulation 252 for the meaning of certain expressions used in this regulation.
(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—
(a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and
(b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.
(7) In paragraph (6), “relevant marketing authorisation” means—
(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or
(c) a UKMA(UK)(Category 2) granted under the unfettered access route.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/251 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-251
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.