- Draft legislation
The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
You are here:
- UK Draft Statutory Instruments
- ISBN 978-0-11-117911-6
- Table of contents
What Version
Opening Options
More Resources
Draft Legislation:
This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 No. 744
2.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
4.Insertion of regulation 2A (list of countries for the purpose of the definition of “marketing authorization”)
6.Omission of regulation 4 (responsibility for functions under the Directive)
7.Amendment of regulation 13 (supply of investigational medicinal products for the purpose of clinical trials)
9.Amendment of regulation 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics)
10.Amendment of regulation 21 (clinical trials conducted in third countries)
12.Amendment of regulation 31 (suspension or termination of clinical trial)
13.Amendment of regulation 31A (trial master file and archiving)
14.Amendment of regulation 33 (notification of suspected unexpected serious adverse reactions)
15.Amendment of regulation 34 (clinical trials conducted in third countries)
16.Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)
17.Amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)
19.Insertion of regulation 43A (approved country for import)
20.Amendment of regulation 45 (suspension and revocation of manufacturing authorisation)
23.Insertion of regulation 57 (functions in relation to good clinical practice)
24.Amendment of Schedule 3 (particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial)
25.Amendment of Schedule 7 (standard provisions for manufacturing authorisations)
26.Insertion of Schedule 13 (transitional provisions in relation to EU Exit)
Options/Help
Print Options
PrintTable of Contents
PrintThe Whole Instrument
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
Draft Explanatory Memorandum
Draft Explanatory Memorandum sets out a brief statement of the purpose of a Draft Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Draft Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Impact Assessments
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
- Why the government is proposing to intervene;
- The main options the government is considering, and which one is preferred;
- How and to what extent new policies may impact on them; and,
- The estimated costs and benefits of proposed measures.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.