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EU Transition – gov.uk update

EU Transition Updates
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gov.uk

Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021

Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021.
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Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021

This guidance contains information about registration of clinical trials, publishing trial results and future requirements from 1 January 2021.
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Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021

The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs) from 1 January 2021.
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Acting as a Responsible Person (import) from 1 January 2021

From 1 January 2021, a wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
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Guidance on substantial amendments to a clinical trial from 1 January 2021

This guidance covers substantial amendments to a clinical trial including changes to the trial sponsor/legal representative, Investigational medicinal product certification and importation and amendments to the Research Ethics Committee.
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Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021

The MHRA will continue to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs) from 1 January 2021.
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Registering new packaging information for medicines from 1 January 2021

How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
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Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

How the ‘Written Confirmation’ process for active substances manufactured in Great Britain (England, Wales and Scotland) will be handled from 1 January 2021.
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Registering to make submissions to the MHRA from 1 January 2021

Submissions related to human medicines would need to be submitted directly to the MHRA.
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How to comply with REACH chemical regulations

How to comply with the EU’s REACH chemical regulations when using, making, selling or importing chemicals in the EU, and how to prepare for 1 January 2021.
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Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021

The way you apply to licence biological products will change from 1 January 2021.
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Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021

Provides information on the format and content of paediatric applications in the United Kingdom (UK) from 1 January 2021.
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Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021

Importing investigational medicinal products for use in clinical trials from 1 January 2021
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Regulating medical devices from 1 January 2021

How medical devices are regulated in the UK will change after the transition period has ended.
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Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021

The process for applicants applying for a Paediatric Investigation Plan (PIP) waiver from 1 January 2021.
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Reference Medicinal Products (RMPs) from 1 January 2021

There will be changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications from 1 January 2021.
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List of approved countries for authorised human medicines from 1 January 2021

Approved countries for batch testing and importation of medicines from 1 January 2021
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Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021

How traditional herbal medicines and homoeopathic medicines will be treated by the MHRA from 1 January 2021.
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Completed Paediatric Studies – submission, processing and assessment from 1 January 2021

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) from 1 January 2021
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Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes

This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
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Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021

This guidance provides further information on comparator products used in studies supporting abridged marketing authorisation applications
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Guidance on pharmacovigilance procedures in the event from 1 January 2021

This guidance summarises our approach to pharmacovigilance from 1 January 2021.
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Importing medicines on an approved country for import list from 1 January 2021

The actions to take for importing medicines in different circumstances.
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Webinars: preparing to make submissions to the MHRA from 1 January 2021

Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems to use from 1 January 2021.
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Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

This guidance sets out how the MHRA will handle centralised applications that are still pending on 1 January 2021.
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Applying for a Certificate of Pharmaceutical Product from 1 January 2021

Applying for a Certificate of Pharmaceutical Product (CPP) from 1 January 2021.
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Renewing Marketing Authorisations for medicines from 1 January 2021

The way Marketing Authorisations (MAs) are processed will change from 1 January 2021.
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How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021

How the MHRA will assess Marketing Authorisation Applications (MAA) for medicines referred under Article 29 from 1 January 2021.
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MHRA post-transition period information

Guidance for industry and organisations to follow from 1 January 2021.
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Placing manufactured goods on the market in Great Britain from 1 January 2021

What you need to do to comply with regulations on manufactured goods you place on the GB market from 1 January 2021.
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Placing manufactured goods on the EU market from 1 January 2021

What you need to do to comply with regulations on manufactured goods you place on the market from 1 January 2021.
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Using the UKCA mark from 1 January 2021

Find out if you will need to use the new UKCA marking and how to use it.
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Conformity assessment bodies: change of status from 1 January 2021

How conformity assessment bodies will be affected from 1 January 2021.
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Importing and exporting live aquatic animals from 1 January 2021

How importers and exporters of live aquatic animals for aquaculture and for ornamental purposes should prepare for changes from 1 January 2021.
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Joint Ministerial Committee (EU Negotiations) communiqué: 3 September 2020

Communiqué from the twenty-fifth meeting of the Joint Ministerial Committee (EU Negotiations).
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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Pharmacovigilance system requirements from 1 January 2021
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Passport rules for travel to Europe from 1 January 2021

Advice for British passport holders from January 2021.
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Trade with the UK from January 2021: prepare your EU business

From 1 January 2021 the rules for trading with the UK will change. If you’re a business based in the EU, find out how you can prepare to continue trading with the UK.
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Import of products, animals, food and feed system (IPAFFS)

Use IPAFFS to notify authorities that you’re importing live animals and germinal products into England, Scotland and Wales from the EU.

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Moving goods into, out of, or through Northern Ireland from 1 January 2021
What UK businesses can do now to get ready for 2021.

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Export fish to the EU from 1 January 2021

How to export fish for human consumption from 1 January 2021, what documents you may need and customs rules to follow.
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Marking, labelling and marketing standards from 1 January 2021

Marking, labelling and marketing standards you must follow to import and export food, plant seeds and manufactured goods from 1 January 2021.

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Customs, VAT and Excise UK Transition legislation from 1 January 2021

This collection brings together EU Exit legislation, regulations and notices for Customs procedures applicable to UK Transition.

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