PART 5Amendment of Part 5 (marketing authorisations)

Amendment of regulation 71 (withdrawal of medicinal product from the market)I180

1

Regulation 71 M1 is amended as follows.

2

In paragraph (1)—

a

for sub-paragraph (a) substitute—

a

under regulation 68 the licensing authority revokes or suspends a UK marketing authorisation or parallel import licence; or

F1b

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.