Paragraph 183 I1

Before regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) insert—

“Amendment of regulation 335 (contravention due to fault of another person)

224ZA

In regulation 335(6)(b) for “268 and 269” substitute “ 268, 268A, 269 and 269A ”.

Amendment of regulation 336 (warranty as defence)

224ZB

In regulation 336(3)(b) for “268 and 269” substitute “ 268, 268A, 269 and 269A ”.

Amendment of regulation 340 (presumptions)

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) ”.

Amendment of Schedule 32 (transitional provisions and savings)

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) ”.”.