EU Exit and Post Transition Guidance

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency will be the UK’s standalone medicines and medical devices regulator.

Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

Stakeholders need to get ready for new rules from 1 January 2021. The agency has now published guidance which will apply following the end of the transition period, from 1 January 2021, and which will be developed further in due course.

To help stakeholders understand the detail of the guidance and to ask any questions, the agency is running a series of free webinars on important topics.

Agenda

Monday 19 October 2020, 14:00-15:30

Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021

(Held by The National Institute for Biological Standards and Controls)

This webinar will look at batches for the marketing in GB and Northern Ireland. The following topics will be discussed; sample submission, Lot release protocols, NIBSC certifications, marketing information forms, risk-based approach to independent testing, parallel testing and turnaround times.

Bookings for this webinar have now closed. To receive a recording of the presentation (without the Q&A) please register for updates.

Tuesday 20 October 2020, 14:00-15:30

UK supply chain regulation from 1 January 2021

This webinar will provide attendees with an in-depth understanding of the regulatory requirements UK medicines supply after 1 January 2021. Understand the implementation of published guidance and take the opportunity to ask questions relevant to your own products and supply chains.

Due to exceptional demand, this event is now fully booked. To receive recordings of the presentations (without the Q&A) or to hear from us if places become available, register for updates.

Wednesday 21 October 2020, 10:00-11:30

Clinical Trials

This webinar will cover aspects of clinical trials that will apply from 1 January 2021. We will discuss applying for a CTA, trial registration and results reporting plus reporting of SUSARs. The webinar will also cover supply of IMP.

Due to exceptional demand, this event is now fully booked. To receive recordings of the presentations (without the Q&A) or to hear from us if places become available, register for updates.

Wednesday 21 October 2020, 14:00-15:00

Regulation of medical devices from 1 January 2021

This webinar will cover the regulation of medical devices from 1 January 2021. We will discuss new registration and UK Responsible Person requirements, and provide an overview of the UKCA mark – which can be used on a voluntary basis from January 2021.

Due to exceptional demand, this event is now fully booked. To receive recordings of the presentations (without the Q&A) or to hear from us if places become available, register for updates.

Thursday 22 October 2020, 10:00-11:30

Post EU Transition: Pharmacovigilance requirements for UK authorised products

This webinar will cover the revised regulatory framework for pharmacovigilance in the UK, the submission and assessment of pharmacovigilance data for UK authorised products, and requirements concerning the qualified person for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF).

Due to exceptional demand, this event is now fully booked. To receive recordings of the presentations (without the Q&A) or to hear from us if places become available, register for updates.

Tuesday 27 October 2020, 10:00-11:30

UK marketing authorisation and variation procedures from January 2021

Review of MHRA guidance on new UK routes for marketing authorisation applications and variations, including applications containing new active substances, biosimilars and generic products and incentives for products intended to treat rare diseases. The session will also include information on variation submissions to MHRA from 1 January 2021.

Due to exceptional demand, this event is now fully booked. To receive recordings of the presentations (without the Q&A) or to hear from us if places become available, register for updates.

Tuesday 27 October 2020, 14:00-15:30

Conversion of Community Authorisations to Great Britain MAs and handling of applications that are pending in the centralised and MRDC procedures at the end of Transition.

This webinar will cover how MHRA will handle conversion of Community Authorisations (MAs) to a Great Britain MA, pending Centralised Applications and approved and pending Mutual Recognition/Decentralised marketing authorisations on the 1 January 2021. The webinar will provide guidance on the options for a smooth transition and resolve any technical or procedural issues for a MA holder.

Wednesday 28 October 2020, 10:00-11:30

PLPI – the legal framework of parallel imports

A discussion on the legal framework for parallel imports from 1 January 2021.

Thursday 29 October 2020, 10:00-10:45

UK paediatric requirements from 1 January 2021

This webinar will explain the process for applicants applying for a UK Paediatric Investigation Plan (PIP), waiver, deferral, modification or compliance check from 1 January 2021. Paediatric requirements for UK Marketing Authorisation Holders will also be covered.

To keep up to date with new guidance and supporting events, visit Gov.UK or look out for announcements on our social media channels.

Frequently Asked Questions

Will the session be recorded and made available later?

Recordings of the presentations, excluding the Q&A sessions, will be released in due course.

I couldn’t book a ticket for my chosen webinar. What can I do?

We have experienced very high demand for these events. If you were not able to book a ticket for your chosen webinar, please register for updates. We will let you know if places become available and when the recordings of the presentations are ready to access.

Will you consider repeating any of these events?

We are closely monitoring registered interest in the events and will be assessing demand for repeated events on a case-by-case basis. We would ask those who have registered but who may not be able to attend their chosen event(s), to let us know so we can re-allocate the ticket. Email conferences@mhra.gov.uk if you are no longer planning to join.

Will captioning be available for these webinars?

Recordings will be made of the presentations and captioning will be added to these. Anyone who has joined the webinar or registered their interest will be notified of the availability the recordings.

When will I receive details of how to join the webinar?

Once your booking is confirmed further joining instructions will be emailed at least 48 hours before the webinar is scheduled to take place.

What if I have a question regarding the webinar?

For all questions regarding access and delivery of the webinar please contact the Events Team via email at conferences@mhra.gov.uk

What if I have a question about the areas of guidance being covered?

For more details about our Transition guidance, please visit our post transition period information on our website.

Access requirements:

If you have any access requirements that we may address to make your participation at our meeting more enjoyable, please do let us know when registering.

Data Protection

The Medicines and Healthcare products Regulatory Agency will use the information you have provided via the third-party data processor Eventbrite, to facilitate the event, provide you with an acceptable level of service. Any access requirements will be processed internally and will not be shared in any identifiable way with the venue. We will contact you using the information provided for the purpose of this event.

To find out how we use and manage your personal data please visit the MHRA Privacy Notice .

The National Institute for Biological Standards and Control (NIBSC) has its own privacy notice which outlines how we collect and use personal data in accordance with the Data Protection Act 2018 and the General Data Protection Regulation (GDPR) 2016/679.

To find out how we use and manage your personal data please visit the NIBSC Privacy Notice.

By providing the information you agree to the data being processed and stored as outlined.

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