Regulation 33 Amendment of Schedule 30I1

Schedule 30 M1 (particulars for advertisements to persons qualified to prescribe or supply) is amended as follows.

In paragraph 2, after “holder of” insert “ the temporary authorisation or ”.

In paragraph 6, after “for the product” insert “ or, in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174, the indications for the medicinal product consistent with the recommendation or requirement of the licensing authority as to the use of that product ”.

In paragraph 7, after “product characteristics” insert “ , or in any equivalent summary published by the holder of a temporary authorisation, ”.