Medicines Act 1968

Notification of proposals to holder of licence in other cases

8 Except as provided by paragraph 11 of this Schedule, where the licensing authority propose, in the exercise of the powers conferred by section 28 of this Act.—

(a) to suspend, revoke or vary a licence under Part II of this Act, other than a product licence, or

(b) to suspend, revoke or vary a product licence where no notice of that proposal, or of any advice, or grounds for giving advice, which led to that proposal, has been given to the holder of the licence under paragraph 2, paragraph 4 or paragraph 6 of this Schedule,

the licensing authority shall serve on the holder of the licence a notice stating their proposals and the reasons for them and the date (not being earlier than twenty-eight days from the date of service of the notice) on which it is proposed that the suspension, revocation or variation should take effect.

9 If, before the date specified in a notice under paragraph 8 of this Schedule, the holder of the licence gives notice to the licensing authority of his desire to be heard under this paragraph, or makes representations in writing to the licensing authority with respect to their proposals, then, before determining the matter, the licensing authority shall afford to him an opportunity of appearing before, and being heard by a person appointed for the purpose by the licensing authority, or shall take those representations into account, as the case may be.