Regulation 76 Renewal of conditional marketing authorisation

After regulation 66A, insert—

“Renewal of conditional marketing authorisation

66B.

(1)

The licensing authority may renew a conditional marketing authorisation in relation to an application made to it by the holder of the authorisation.

(2)

The application must be made at least six months before the date on which the conditional marketing authorisation is due to expire.

(3)

The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.

(4)

When considering an application under paragraph (1), the licensing authority must consider whether—

(a)

the positive therapeutic effects of the product continue to outweigh the risks to the health of patients and the public associated with the product; and

(b)

the obligations referred to in regulation 59(4C) and any time limits for their fulfilment remain appropriate, modifying or removing them if necessary.

(5)

The provisions of regulation 66(2), (3), (4), (6) and (8) apply to an application for renewal of a conditional marketing authorisation.”.