Paragraph 97 I1

For regulation 129 (amendment of regulation 146 (obligation in relation to product information)) substitute—

“129

For regulation 146(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 for sale or supply in Northern Ireland—

(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 for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).”.”.