Regulation 107 Amendment of regulation 116 (obligation in relation to product information)F1I1

For regulation 116(2), substitute—

“(2)

In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a)

in the case of a medicinal product authorised by a COR(NI) or COR(UK)—

(i)

the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii)

the UK web-portal established in accordance with regulation 203(1);

(b)

in the case of a medicinal product authorised by a COR(GB), the UK web-portal established in accordance with regulation 203(1).”.