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Medicines Act 1968

Changes over time for: Section 107

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Version Superseded: 29/08/2006

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107 Validity of decisions and proceedings relating thereto.U.K.

(1)Except as provided by the following provisions of this section, the validity of any decision of the licensing authority under Part II of this Act or of a Minister under section 75 of this Act, and the validity of any licence or certificate granted or issued or other thing done in pursuance of any such decision, shall not be questioned in any legal proceedings.

(2)If the person to whom such a decision relates desires to question the validity of the decision on the grounds—

(a)that it is not within the powers of this Act, or

(b)that any of the requirements of this Act or of any regulations made under this Act, which are applicable to the matter to which the decision relates, have not been complied with,

that person may, at any time within the period of three months from the date on which notice of the decision is served on him, make an application to the High Court under this section.

(3)On any application under this section the High Court—

(a)may by interim order suspend the operation of the decision to which the application relates until the final determination of the proceedings;

(b)if satisfied that the decision is not within the powers of this Act, or that the interests of the person making the application have been substantially prejudiced by a failure to comply with any of the requirements mentioned in subsection (2)(b) of this section, may quash the decision.

(4)Where a decision to grant a licence or certificate is quashed under this section, any licence or certificate granted in pursuance of that decision shall be void, and any proceedings on the application for the grant of the licence or certificate may be continued as if no such decision had been made.

(5)In the application of this section to Scotland, any reference to the High Court shall be construed as a reference to the Court of Session.

(6)In the application of this section to Northern Ireland, any reference to the High Court shall be construed as a reference to a judge of the High Court of Justice in Northern Ireland.

Modifications etc. (not altering text)

C1Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

C2S. 107 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

S. 107 extended (with modifications)(14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

S. 107 applied (with modifications) (1.1.1995) by s.I. 1994/3144, reg.10, Sch. 4

S. 107 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

C3Ss. 107-116 applied (with modifications) (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), regs. 1, 47, Schs. 9

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