PART 5Amendment of Part 5 (marketing authorisations)

Amendment of regulation 71 (withdrawal of medicinal product from the market)80.

(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”; and

F1(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.”.