Regulation 160 Challenge to provisional determination

(1)

A recipient of a provisional determination notice may, within the period of four weeks beginning immediately after the determination date, give notice in writing to the licensing authority requesting the authority to submit the provisional determination to review.

(2)

If the recipient gives such notice the recipient must—

(a)

within the period specified in the provisional determination notice, make written representations to the licensing authority explaining why the recipient thinks the product is not a medicinal product; or

(b)

within the period of four weeks beginning immediately after the determination date, inform the licensing authority in writing that the recipient wants to make oral representations explaining why the recipient thinks the product is not a medicinal product.

(3)

If—

(a)

the recipient has informed the licensing authority that the recipient wants to make written representations in accordance with paragraph (2)(a); and

(b)

the licensing authority thinks that, because of exceptional circumstances or the nature or complexity of the issues involved, additional time is needed for the preparation of written representations,

the licensing authority may alter the period for making written representations.

(4)

The licensing authority must inform the recipient in writing of an alteration under paragraph (3) and of the reasons for it.