The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
text
text/xml
en
EXITING THE EUROPEAN UNION
MEDICINES
Statute Law Database
2024-05-16
Expert Participation
2021-08-03
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
reg. 17(4)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 1
para. 3
reg. 1
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 11Amendment of Part 11 (Pharmacovigilance)
F1Amendment of regulation 204 (obligation on licensing authority in relation to public announcements)I1165
F2In regulation 204 F3, in paragraph (1), after “pharmacovigilance concerns” insert “which relate to products authorised under a UKMA(NI) or UKMA(UK).