SCHEDULE 5 U.K.Information about supply of unbranded generic health service medicines or special health service medicines: transitional provisions

Transitional provision: information about supply of special health service medicines U.K.

4.—(1) A Specials MoU member is not required to comply—

(a) with regulation 11, 12 or 13 in any month which falls within a transitional quarter, or

(b) with regulation 14 in respect of any transitional quarter.

(2) But this paragraph is subject to paragraph 5.

(3) In this paragraph and paragraph 5—

“Specials MoU end date” means the day on which the Specials MoU ceases to operate following notice of termination being given by the Secretary of State in accordance with the MoU;

“Specials MoU member” means a UK producer who, immediately before 1st August 2018, is a participating manufacturer for the purposes of the Specials MoU;

“transitional quarter” means a quarterly period (determined in accordance with regulation 14(2)) which begins—

(a)

on or after 1st August 2018, but

(b)

before the day on which the Specials MoU end date.

(4) For the purposes of this paragraph, it does not matter whether the Secretary of State gives notice of termination in accordance with the Specials MoU before, on or after 1st August 2018.