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183. Before regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) insert—
224ZA. In regulation 335(6)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.
224ZB. In regulation 336(3)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.
224ZC. In regulation 340(5) for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.
224ZD. In paragraph 3(10) of Schedule 32 for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.”.
184. For regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) substitute—
“224. In regulation 341(4)—
(a)in paragraph (a), insert “UK” before “marketing authorisation”;
(b)after paragraph (a), insert—
“(aa)a decision to grant or revoke an EU marketing authorisation;”.”.
185. In regulation 225 (insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers)), in the inserted regulation 344A(5) for “exit day” substitute “IP completion day”.
186. For regulation 226 (amendment of regulation 345 (immunity from civil liability)) substitute—
“226. In regulation 345(5), for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”.”.
187. In regulation 227 (amendment of regulation 346 (Secretary of State to carry out a review of certain provisions))—
(a)in paragraph (a), for “paragraphs (iia)” to “(xxviiij)” substitute “paragraph (xixa)”;
(b)in paragraph (b), for “paragraphs (ia) and (ivab)” substitute “paragraph (ia)”.
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