Paragraph 58 I1

In regulation 80(2) (amendment of regulation 71 (withdrawal of medicinal product from the market)) for sub-paragraph (b) substitute—

“(b)

for sub-paragraph (b) substitute—

“(b)

under—

(i)

regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within Great Britain of a product to which a UKMA(GB) relates; or

(ii)

regulation 69 or Article 20(4) of Regulation (EC) No 726/2004 the licensing authority suspends the use, sale, supply or offer for sale or supply within Northern Ireland of a product to which a UKMA(NI) or UKMA(UK) relates.”.”.