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SCHEDULES

SCHEDULE 2 U.K. Suspension, Revocation or Variation of Licence

Modifications etc. (not altering text)

C1Sch. 2 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

Sch. 2 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

Consultation with appropriate committee or CommissionU.K.

1U.K.Except as provided by paragraph 11 of this Schedule, where the licensing authority propose, in the exercise of their powers under section 28 of this Act,—

(a)to suspend, revoke or vary a product licence on the grounds specified in paragraph (a) or paragraph (c) of subsection (3) of that section, in a case where it appears to the licensing authority that the matters or characteristics in question are such as to affect the safety, efficacy or quality of medicinal products of a description to which the licence relates, or

(b)to suspend, revoke or vary a product licence on any of the grounds specified in paragraph (g) or paragraph (h) of that subsection,

the licensing authority shall not suspend, revoke or vary the licence except after consultation with the appropriate committee or, if for the time being there is no such committee, with the Commission.