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The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021
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- UK Statutory Instruments
- 2021 No. 1452
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3.Amendments to regulation 5 (classification of medicinal products)
5.Amendments to regulation 18 (wholesale dealing in medicinal products)
6.Amendment to regulation 19 (exemptions from requirement for wholesale dealer’s licence)
7.Amendments to regulation 26 (general power to suspend, revoke or vary licences)
9.Amendment to regulation 39 (further requirements for manufacturer’s licence)
10.Amendments to regulation 42 (conditions for wholesale dealer’s licence)
11.New regulation 43ZA (obligations of licence holder – listed NIMAR products)
12.Amendment to regulation 45 (requirement as to responsible persons)
13.Amendment to regulation A81 (application of regulations 81 to 94)
14.New regulation 167A (NIMAR supply to Northern Ireland) and new regulation 167B (list of NIMAR products)
15.Amendment to regulation 187 (recording obligations on holders)
16.Amendment to regulation 188 (reporting obligations on holders)
17.Amendment to regulation 229 (exemption for supply by national health service bodies and local authorities)
18.Amendment to regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists)
19.Amendment to regulation 231 (exemption for supply etc under a PGD by independent hospitals etc)
20.Amendment to regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business)
21.Amendment to regulation 234 (exemption for supply etc of products under a PGD to assist the police etc)
22.Amendment to regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations)
24.Amendments to Schedule 4 (standard provisions of licences under Part 3) Part 2 (manufacturer’s licence relating to the import of medicinal products from a state other than an EEA State/Country other than an Approved Country for Import)
25.In Schedule 4, after paragraph 23, insert— The licence holder in Great Britain must take all reasonable...
26.Amendment to Schedule 7 (qualified persons) Part 3 (obligations of qualified person)
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