Paragraph 61

For regulation 84 (amendment of regulation 76 (obligation in relation to product information)) substitute—

“84.

For regulation 76(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 for sale or supply by a UKMA(NI) or a UKMA(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 for sale or supply by a UKMA(GB), the UK web-portal established in accordance with regulation 203(1).”.”.