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The Human Medicines (Amendment) Regulations 2019
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- Northern Ireland Statutory Rules
- 2019 No. 10
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4.Amendment of regulation 36 (conditions for manufacturer’s licence)
5.Amendment of Regulation 39 (further requirements for manufacturer’s licence)
6.Amendment of regulation 42 (conditions for wholesale dealer’s licence)
7.Insertion of regulation 43A (requirement for wholesale dealers to decommission the unique identifier)
8.Insertion of regulation 94A (offences relating to Commission Regulation 2016/161)
9.Insertion of regulation 226A (sale etc by a pharmacist in accordance with a serious shortage protocol)
12.Amendment of regulation 268 (enforcement relating to packaging and package leaflets: holder of authorisation etc)
13.Amendment of regulation 269 (offences relating to packaging and package leaflets: other persons)
14.Amendment of regulation 323 (enforcement in England, Wales and Scotland)
15.Amendment of regulation 327 (powers of inspection, sampling and seizure)
16.Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions)
18.Amendment of Schedule 17 (exemption for sale, supply or administration by certain persons)
19.Amendment of Schedule 24 (packaging information requirements)
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