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Medicines Act 1968

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21 Procedure on reference to appropriate committee or Commission. E+W+S+N.I.

(1)Where the appropriate committee or the Commission are consulted under subsection (3) of section 20 of this Act with respect to an application for the grant of a licence, and on any such grounds as are specified in that subsection they have reason to think that they may be unable to advise the licensing authority to grant the licence, or may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application, the committee or Commission shall notify the applicant accordingly, and, before giving their advice to the licensing authority, shall afford to him an opportunity of appearing before and being heard by them, or of making representations in writing to them with respect to those grounds.

(2)Where the applicant has availed himself of the opportunity of being heard under the preceding subsection, or after considering any representations made by him under that subsection, the appropriate committee or the Commission, as the case may be, shall report to the licensing authority their findings and advice and the reasons for their advice and the licensing authority shall take that report into account in determining the application.

(3)Whether the applicant has been heard or has made representations under subsection (1) of this section or not, if the appropriate committee or the Commission advise the licensing authority that the licence ought on any such grounds as are referred to in that subsection to be refused, or ought, if granted. to contain provisions specified in their advice, the licensing authority shall serve notice on the applicant stating the advice so given to the authority and the reasons stated by the appropriate committee or the Commission for giving that advice.

(4)If, within the time allowed after the service of a notice under subsection (3) of this section, in a case where the applicant has not been heard by, or made representations to, the Commission under subsection (1) of this section, he gives notice to the licensing authority of his desire to be heard with respect to the advice given to the authority or makes representations in writing to the licensing authority with respect to that advice, then, before determining the application,—

(a)if the applicant has given notice of his desire to be heard, the licensing authority shall arrange for him to have an opportunity of appearing before, and being heard by, the Commission, or

(b)if he has made representations in writing, the licensing authority shall refer those representations to the Commission,

and, where the applicant has availed himself of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report to the licensing authority their findings and advice and the reasons for their advice, and the licensing authority shall take that report into account in determining the application.

(5)If the licensing authority—

(a)propose to determine the application in a way which differs from the advice of the Commission under subsection (2) or subsection (4) of this section, or

(b)where there has been no hearing before, and no representations have been made or referred to, the Commission, propose to determine the application in a way which differs from the advice of the appropriate committee under subsection (2) of this section, or

(c)in the absence of any such advice as is mentioned in either of the preceding paragraphs, propose to determine the application in a way which differs from the advice given by the appropriate committee or the Commission, or

(d)propose, on grounds not relating to safety, quality or efficacy, to refuse to grant the licence, or to grant a licence otherwise than in accordance with the application,

the licensing authority shall notify the applicant accordingly, and, before determining the application, shall afford to the applicant an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or of making representations in writing to the licensing authority with respect to that proposal.

(6)Any notification given to the applicant under subsection (5) of this section—

(a)in a case falling within paragraph (a) or paragraph (b) of that subsection, shall state the advice of the Commission or of the appropriate committee and the reasons stated by the Commission or the committee for giving that advice, or

(b)in a case falling within paragraph (c) of that subsection, shall state the advice given by the appropriate committee or the Commission and the reasons stated by the committee or the Commission for giving that advice,

and in a case falling within paragraph (d) of that subsection (whether it also falls within any of the other paragraphs of that subsection or not) the notification shall include a statement of the proposals of the licensing authority and of the reasons for them.

(7)Where under subsection (5) of this section the applicant avails himself of the opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority—

(a)the person so appointed shall not, except with the consent of the applicant, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act;

(b)if the applicant so requests, the hearing shall be in public; and

(c)if the applicant so requests, the licensing authority shall furnish to him a copy of the report of the person so appointed.

(8)In this Part of this Act “the time allowed” means the period of twenty-eight days or such extended period as the licensing authority may in any particular case allow.

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Modifications etc. (not altering text)

C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2Ss. 20-22 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

C3Definitions in ss. 18-22 applied (N.I.) (1.4.1992) by S.I. 1991/194, (N.I. 1), art. 7(2), Sch. 2 para. 5(4); S.R. 1991/131, art. 2(e), Sch. Pt.III

C4S. 21 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

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