Given that the pharmaceutical and medical devices industry is subject to more EU derived legislation than most other industries, the impact of a no-deal Brexit will be significant following the end of the transition period.
As a result, pharmaceutical and medical device companies across these industries will be affected in a broad range of areas from product development, to market approval, to the shipping of medicines and medical devices.
Supply and demand
So how will the supply of medicines and availability of medical devices within the EU fair in the uncertain waters which a no-deal Brexit presents?
At the end of the transition period mutual recognition of regulatory regimes will cease and the UK will become a “third country” to the EU.
In order to allow for minimal disruption to the supply of medicines within the EU, pharmaceutical and medical device companies should consider putting in place robust contingency plans to allow them the flexibility to adapt as the situation develops.
Contingency planning for pharmaceutical companies
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has provided guidance for industry and organisations to follow from 1 January 2021.The following regulatory consequences should be considered by pharmaceutical companies in light of this guidance in order to ensure the continuous supply of medicines to the EU from 1 January 2021:
Certificates, licences or authorisations issued by UK notified bodies will no longer be valid within the EU
Pharmaceutical companies that currently rely on UK licences and authorisations originating within the UK must transfer them to an EU member state to ensure compliance with EU law and in order to continue supplying the EU market with their medicines.
Pharmaceutical companies must ensure that the reference member state for marketing authorisations issued through the mutual recognition procedure (MRP) or decentralised procedure (DCP) is based in the EU.
With regards to pharmacovigilance operations, marketing authorisation holders must also ensure that their EU qualified person responsible for pharmacovigilance (QPPV) is located within the EU.
Batch release and quality control (QC) testing sites in the UK should be relocated to the EU.
For clinical trials, transfer of any UK based sponsor or legal representative should be made to the EU
Pharmaceutical companies within the UK that are not in compliance with EU law may no longer be able to put medicines on the EU market until they make the necessary changes.
Contingency planning for medical device companies and economic operators
The MHRA has provided a guidance on regulating medical devices and has outlined the steps of what is needed to be done in order to place a medical device on the UK, Northern Ireland and EU markets from 1 January 2021.
In light of this, the following should be considered by manufacturers/economic operators intending to continue placing medical devices on the EU Market from 1 January 2021.
UK notified bodies will no longer be considered EU notified bodies and manufacturers based outside the EU with UK authorised representatives will be required to transition to EU-27 authorised representatives.
If you or your product suppliers rely on a UK notified body for certification, existing “CE” certification must be transferred to an EU-27 notified body. Alternatively, you should consider obtaining new certification from an EU-27 notified body.
Medical devices placed on the EU Market must ensure an EU-27 notified body and/or EU-27 authorised representative is identified on the labelling, in order to be in compliance with labelling requirements.
Distributors who place medical devices from the UK on the EU market will be considered importers and will be required to adhere to EU legislative obligations that differ from those applying to products sourced from within the EU-27. Economic operators should be conscious that this may have wide-reaching consequences as the Product Liability Directive 85/374/EEC imposes liability on the importer.
Companies will also have to ensure they comply with any new custom requirements that the UK may put in place.
For more information on Brexit & medical devices please see here.
The operational and regulatory burdens on the pharmaceutical and medical devices industry from the 1 January 2012 will be vast. Contingency plans should be put in place to mitigate the potential impact of the UK becoming a “third country” to the EU.
We have considerable experience in guiding companies involved in the manufacture and supply of medicinal products and medical devices through the relevant regulatory frameworks and how they might address the potential issues raised by a no-deal Brexit.
The content of this article is provided for information purposes only and does not constitute legal or other advice.