- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
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- Offerynnau Statudol y Deyrnas Unedig
- 2019 No. 775
- PART 11
- Regulation 167
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Nodweddion Uwch
- Dangos Graddfa Ddaearyddol(e.e. Lloegr, Cymru, Yr Alban aca Gogledd Iwerddon)
- Dangos Llinell Amser Newidiadau
Rhagor o Adnoddau
Changes to legislation:
There are currently no known outstanding effects for the The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Section 167.
Changes to Legislation
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Insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)U.K.
This
adran has no associated
Memorandwm Esboniadol
167. After regulation 205 insert—
“Further obligations in respect of pharmacovigilance activitiesU.K.
Further obligations in respect of pharmacovigilance activities
205A.—(1) Schedule 12A [F1applies in relation to medicinal products for sale or supply under a UKMA(GB) or THR(GB) and] makes further provision as to the obligations of a holder and the licensing authority in respect of the performance of pharmacovigilance activities under this Part.
(2) [F2The Secretary of State] may by regulations [F3in respect of Great Britain] amend Schedule 12A.
(3) Regulations under paragraph (2) may make provision regarding the performance of pharmacovigilance activities under this Part as to—
(a)the content and maintenance of the pharmacovigilance system master file kept by the holder;
(b)the minimum requirements for the quality system for the performance of pharmacovigilance activities by the holder and the licensing authority;
(c)the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;
(d)the minimum requirements for the monitoring of data recorded by the licensing authority pursuant to regulation 185 (recording obligations on the licensing authority) to determine whether there are new risks or whether risks have changed;
(e)the format and content of electronic transmission of suspected adverse reactions by a holder;
(f)the format and content of electronic periodic safety reports and risk management plans; and
(g)the format of protocols, abstracts and final study reports for the post-authorisation safety studies.”.
Textual Amendments
F1Words in reg. 167 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 134(a)
F2Words in reg. 167 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 134(b)(i)
F3Words in reg. 167 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 134(b)(ii)
Commencement Information
I1Reg. 167 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
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