The Human Medicines Regulations 2012

Compliance with standards specified in certain publications
This section has no associated Explanatory Memorandum

251.—(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.