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We are the only trade association representing the interests of manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.

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Home / Policy / Brexit

Brexit and the UK-EU economic partnership

We’re leading advocacy and representing the OTC sector on Brexit. On this page you’ll find more information about our activities, our latest updates and our resources for members.

Key aims of PAGB’s work on Brexit

Ensure that PAGB provides OTC industry perspective in government policy discussions and EU negotiations

We provide unique OTC insight and solutions to government departments and regulators to ensure a negotiated solution which overcomes obstacles for medicines, medical devices and food supplements.

Advocate for smooth implementation and transition of any Brexit related solutions

We present OTC requirements (including complexity related to retailer supply) and ensure that regulatory arrangements for consumer healthcare products do not create unnecessary bureaucratic burdens. Our aim is to avoid duplication of regulatory requirements.

Address challenges

We aim to address the challenges and concerns of our members and raise these with appropriate government officials to seek to provide solutions.

Ensure access for consumer healthcare products across the whole of the UK

We ensure that regulatory solutions are available to overcome issues with supply, both coming into the UK as well as within the UK and going to Northern Ireland.

Provide guidance and support to our members

We provide written guidance for our members to support them through the different stages relating to Brexit. We provide dedicated tailored advice to questions raised by our members.

Input into UK Regulatory Policy post Brexit on the development of UK legislation

We influence government, inputting into UK Regulatory Policy post-Brexit on the development of UK legislation relating to medicines, medical devices and food supplements.

The Windsor Framework

The Windsor Framework was an agreement made between the UK and EU on 27 February 2023. This agreement made changes to the Northern Ireland Protocol which was agreed as part of the UK-EU Withdrawal agreement in 2019.

The Northern Ireland Protocol, which was negotiated to prevent a hard border between Northern Ireland (NI) and the Republic of Ireland, had some unforeseen consequences in a number of areas. This was because Northern Ireland remained under the remit of EU law in many areas, which posed problems for goods entering from Great Britain (GB) into NI as they would be subject to checks in line with EU law.

How have PAGB supported

PAGB welcomed the Windsor Framework due to the fact it was a negotiated solution which would help overcome outstanding issues for medicines and food supplements.
PAGB provided an overview of the agreement and what was needed to clarify implementation shortly after the announcement. Members can read our briefing here.

Implementation of the Windsor Framework

During the remainder of 2023 our main focus has been on supporting the implementation of the Windsor Framework for both medicines and food supplements.

How have PAGB supported

PAGB has worked with government in 2023 across the Department of Health and Social Care (DHSC) and Medicines and Healthcare products Regulatory Agency (MHRA) for medicines, and the Department for Environment, Food & Rural Affairs (Defra) for food supplements to ensure that our members perspectives have been put forward when it has come to implementing the changes needed.
We have ensured that MHRA guidance has been updated to streamline the submission process for medicines.
Our CEO, Michelle Riddalls, provided evidence at the House of Lords on 12 September 2023 to highlight the concerns of our members. Watch our video for more information.
Liaising with our members about the impact of the EU Acquis on medicines legislation in the UK and sharing feedback from the industry with UK government. Read our members briefing here.

Supporting our members

PAGB has updated our member guidance for all product categories to take into account the implementation of the Windsor Framework, Border Target Operating Model and UK specific requirements for medical devices, which impacts import and export in the UK (including Northern Ireland) as well as internal movement to Northern Ireland.

Current PAGB post-Brexit guidance

OTC medicines guidance

Medical devices guidance

Food supplements guidance

Want to keep up to date on the latest industry news on Brexit?

PAGB members can access the latest Brexit updates and news relevant to the consumer healthcare industry on our Brexit intelligence feed.

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PAGB’s post-Brexit legislation and policy work

We have been working closely with government and regulators on changes to UK legislation as a result of the UK’s exit from the EU.

OTC medicines

Review and input into guidance related to International Recognition Procedures

Working with MHRA on MHRA Performance Issues and solutions

Reviewing proposals relating to new streamlined processes at MHRA including licensing and Regulatory Management System (RMS)

Windsor Framework Implementation

Ongoing supply resilience

Medical devices

Review of consultation inputs for Medical Device Legislation

Output from the MHRA consultation on updating UK Medical Device Legislation, including evaluation of UK CA mark

International Recognition Procedures including utilisation of CE Mark

Outstanding concerns relating to Northern Ireland Supply for medical devices

Food supplements

Windsor Framework Implementation

Utilisation of generic term “Probiotic”

Divergence between UK and EU on novel foods and standards

Find out more information about the previous work and guidance produced by PAGB on Brexit

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