Medicines Act 1968

45 Offences under Part II. U.K.

(1) Subject to the next following section, any person who contravenes any of the provisions of section 7, section 8, section 31, section 32, section 34 or section 40 of this Act, or who is in possession of any medicinal pro4duct or animal feeding stuff for the purpose of selling, supplying or exporting it in contravention of any of those sections, shall be guilty of an offence.

(2) Where any medicinal product or animal feeding stuff is imported in contravention of section 7, section 31, section 32 or section 40 of this Act, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other enactment, is in possession of the product or feeding stuff knowing or having reasonable cause to suspect that it was so imported shall be guilty of an offence.

(3) Any person who, being the holder of a product licence or of a clinical trial certificate or animal test certificate, procures another person to carry out a process in the manufacture or assembly of medicinal products of a description to which the licence or certificate relates, and—

(a) does not communicate to that person the provisions of the licence or certificate which are applicable to medicinal products of that description, or

(b) in a case where any of those provisions has been varied by a decision of the licensing authority, does not communicate the variation to that person within fourteen days after notice of the decision has been served on him,

shall be guilty of an offence.

(4) Any person who, being the holder of a product licence or of an animal test certificate, sells or supplies a substance or article to which the licence or certificate relates to another person for the purpose of its being incorporated in any animal feeding stuff, and does not communicate to that person any provisions of the licence or certificate which relate to the incorporation of that substance or article in animal feeding stuffs, or any instructions required by the licence to be communicated by him to persons to whom the substance or article is sold or supplied for that purpose, shall be guilty of an offence.

(5) Where any such provisions of a product licence or animal test certificate as are mentioned in subsection (4) of this section are varied by the licensing authority, and on varying those provisions the licensing authority serve on the holder of the licence or certificate a notice requiring him, within such time (not being less than fourteen days from the date of service of the notice) as may be specified in the notice, to take such steps as may be so specified for making the variation known, either generally or to persons or classes of persons specified in the notice, then if the holder of the licence or certificate does not comply with the requirements of that notice he shall be guilty of an offence.

(6) Any person who, in giving any information which he is required to give under section 44 of this Act, makes a statement which he knows to be false in a material particular shall be guilty of an offence.

(7) Any person who without reasonable excuse fails to comply with a requirement imposed on him by a notice under section 44(2) of this Act shall be guilty of an offence.

(8) Any person guilty of an offence under any of subsections (1) to (6) of this section shall be liable—

(a) on summary conviction, to a fine not exceeding £400;

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

(9) Any person guilty of an offence under subsection (7) of this section shall be liable on summary conviction to a fine not exceeding [F1 level 3 on the standard scale]

Textual Amendments

F1 Words substituted by virtue of (E.W.) Criminal Justice Act 1982 (c. 48, SIF 39:1), ss. 38, 46, (S.) Criminal Procedure (Scotland) Act 1975 (c.21, SIF 39:1), ss. 289F, 289G and (N.I.) S.I. 1984/703 (N.I. 3), arts. 5, 6

Modifications etc. (not altering text)

C1 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2 s. 45 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

C3 S. 45(1)(2)(6)(7)(8)(9) applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.