The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
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King's Printer of Acts of Parliament
2019-08-15
EXITING THE EUROPEAN UNION
MEDICINES
2019-01-01
These Regulations are made in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a), (b), (c), (d), (f) and (g) and (6)) arising from the withdrawal of the United Kingdom from the European Union. They are also made under paragraphs 1(1) and 7(2) of Schedule 4 to the European Union (Withdrawal) Act 2018, insofar as they make provision in relation to fees.
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 11Amendment of Part 11 (Pharmacovigilance)
Amendment of regulation 209 (penalties)173
In regulation 209(3), omit sub-paragraphs (h) and (i).