Medicines Act 1968

81 Grounds for disqualification in certain cases. U.K.

(1) The Statutory Committee shall not give a direction under subsection (1) of section 80 of this Act, in a case falling within paragraph (b) of that subsection, and shall not give a direction under subsection (4) of that section, unless—

(a) one or more of the facts specified in the next following subsection are proved to the satisfaction of the Committee, and

(b) the Committee are of the opinion, having regard to those facts, that the board of the body corporate are, or, as the case may be, the representative is, to be regarded as responsible for the offence or misconduct in question.

(2) The facts referred to in subsection (1)(a) of this section are-

(a) that the offence or misconduct in question was instigated or connived at by the board or by a member of the board, or by the representative, as the case may be;

(b) that, in the case of a body corporate, a member of the board, or an officer of or person employed by the body corporate, had, at some time within twelve months before the date on which the offence or misconduct in question occurred, been guilty of a similar offence or similar misconduct and that the board had, or with the exercise of reasonable care would have had, knowledge of that previous offence or misconduct;

(c) that, in the case of the representative, he or a person employed by him had, at some time within twelve months before the date on which the offence or misconduct in question occurred, been guilty of a similar offence or similar misconduct and (where it was a similar offence or similar misconduct on the part of an employee) that the representative had, or with the exercise of reasonable care would have had, knowledge of that previous offence or misconduct;

(d) if the offence or misconduct in question is a continuing offence or continuing misconduct, that the board, or the representative, had, or with the exercise of reasonable care would have had, knowledge of its continuance;

(e) in the case of an offence in respect of a contravention of an enactment contained in any of the relevant Acts, that the board, or the representative, had not exercised reasonable care to secure that the enactment was complied with.

Modifications etc. (not altering text)

C1 S. 81: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)