Regulation 19 Amendment of regulation 202A (licensing authority power in relation to medicinal products subject to additional monitoring)

For regulation 202A(1)^f1 substitute—

“(1)

The licensing authority may establish a list of medicinal products that are subject to additional monitoring and that are authorised under—

(a)

a UKMA(GB), and

(b)

a UKMA(UK) where the medicinal product is not on the list referred to in Article 23 of Regulation (EC) No 726/2004.”