The Human Medicines Regulations 2012

Offences relating to dealings with medicinal products U.K.

255.—(1) A person is guilty of an offence if the person breaches any of the following provisions of this Part—

(a) regulation 214(1) (prohibition on sale etc of prescription only medicine otherwise than in accordance with prescription from appropriate practitioner);

(b) regulation 214(2) (prohibition on parenteral administration of prescription only medicine otherwise than by or under directions of appropriate practitioner);

(c) regulation 220 (prohibition on sale etc of medicinal product not subject to general sale otherwise than by or under supervision of pharmacist);

(d) regulation 249 (prohibition on sale of prescription only medicine or pharmacy medicine by way of wholesale dealing to person not within Schedule 22);

(e) regulation 251 (compliance with standards specified in certain publications); or

(f) regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products).

(2) A person is guilty of an offence if the person—

(a) is an appropriate practitioner by virtue of regulation 214; and

(b) gives a prescription or directions in respect of a medicinal product in relation to which the person is not an appropriate practitioner.

(3) A person is guilty of an offence if the person gives a prescription or directions or administers a medicinal product without meeting the conditions for doing so that apply to that person by virtue of regulation 215 (conditions to be met by supplementary prescriber).

(4) A person (“P”) is guilty of an offence if—

(a) P has in P's possession a medicinal product to which regulation 214(1) applies; and

(b) P intends to supply it otherwise than in accordance with a prescription of an appropriate practitioner.

(5) A person guilty of an offence under any of paragraphs (1) to (4) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(6) A person is guilty of an offence if the person breaches—

(a) regulation 221 (prohibition on sale of medicinal product subject to general sale otherwise than in accordance with that regulation); or

(b) regulation 222 (prohibition on sale by automatic machine of medicinal product not subject to general sale).

(7) A person guilty of an offence under paragraph (6) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(8) A person is guilty of an offence if the person breaches regulation 253 (record-keeping requirements for persons carrying on a retail pharmacy business).

(9) A person guilty of an offence under paragraph (8) is liable on summary conviction to a fine not exceeding £400.