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 could be significant when the UK departs the EU.
As a result, pharmaceutical and medical device companies across these industries may 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?
In the event of a no-deal Brexit mutual recognition of regulatory regimes will cease and the UK could become a “third country” to the EU by the withdrawal date.
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 following potential regulatory consequences should be considered by pharmaceutical companies in order to ensure the continuous supply of medicines to the EU in the event of a no-deal Brexit:
- Certificates, licences or authorisations issued by UK bodies may no longer be valid within the EU post Brexit and equally UK businesses may no longer be authorised to issue certificates, licences or authorisations 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 post Brexit.
- 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.
- Post Brexit, pharmaceutical companies 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
According to a recent Heath Products Regulatory Authority (HPRA) press release, the HPRA and/or the Health Service Executive (HSE) are contacting medical device manufacturers, authorised representatives as well as distributors to seek assurances on their contingency planning. The bodies are also seeking to identify any potential issues regarding the availability of specific products associated with Brexit. Equally, the Medicines and Healthcare Products Regulatory Agency (MHRA) continues to provide guidance to relevant UK stakeholders through publications addressing proposed arrangements for the regulation of medicines and medical devices, if there is a no-deal Brexit.
In light of this, the following should be considered by manufacturers/economic operators intending to continue placing medical devices on the EU Market in the case of a no-deal Brexit:
- 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 are likely to 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.
While the potential operational and regulatory burdens arising from a possible no-deal Brexit appear vast, contingency plans can now be put in place to mitigate the potential impact arising from a no-deal Brexit.