However much COVID-19 has disrupted supply chains over the last six months, there is another significant source of upheaval looming for life sciences in Europe as the Brexit transition period ends, with implications for cross-border product movement and ongoing regulatory administration from January 2021.
To this end, the European Medicines Agency (EMA) has updated its guidelines for pharmaceuticals marketing authorisation holders, detailing what they must do to maintain continuity of supply of UK-registered products across the continent after December 31. The new guidelines apply to all marketing authorisation holders (MAHs) for all products registered in the UK. So what are the headline changes?
Resetting boundaries
If UK product registrations have been managed up to now via the EU decentralised procedure (DCP), or via mutual recognition procedure (MRP) in all EU member states, and the UK has acted as the reference member state, that activity must now be switched to a continuing EU country. From the end of 2020, all products registered in the UK will be transferred to a national, UK-specific procedure, requiring the submission of a separate dossier – becoming a stand-alone activity, and ceasing to be aligned with other European countries.
For affected MAHs, switching authorities/procedures could trigger a whole series of actions that need to be taken. These include the submission of variations, as UK-marketed products become nationally registered. As a result, from January, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will have to put in place its own set of rules which will be applicable for new national procedures emerging from MRP and DCP.
New import/export rules and licences and manufacturing/supply-chain requirements will also apply as borders are reinforced between the UK and the EU. As of 1 January 2021, the UK will no longer be part of the EU Customs Union. This means that customs formalities required under Union law will apply to all goods entering the customs territory of the Union from the UK, and the same in reverse.
At the same time, EU businesses wishing to import from or export to the UK will need an Economic Operators Registration and Identification (EORI) number to navigate customs formalities.
EORI numbers issued by the UK will no longer be valid in the Union from January. Businesses based in the UK wishing to import into the Union will need to receive an EU EORI number, or appoint a Union customs representative where applicable. From January, existing ‘economic operator’ authorisations will cease to be valid across the border, too.
Import checks
There will be other logistical considerations as well. Starting next year, the EU Customs Union and the UK will be two separate regulatory and legal spaces. This means that all products exported from the Union to the UK will have to comply with UK rules and standards and will be subject to any applicable regulatory compliance checks and controls on imports.
Similarly, all products imported from the UK to the Union will need to comply with Union rules and standards and will be subject to all applicable regulatory compliance checks and controls on imports for safety, health and other public policy purposes. For biological products, for instance, testing will need to be carried out by the relevant competent authority.
All of this will translate to additional complexity, administration, cost and delay along the supply chain. So where are companies with all of this now, and what actions are outstanding?
Creating a to-do list
Proactive organisations are likely to have switched the competent authority they are registered with already, in anticipation of the Brexit transition period ending. Those that have been distracted by COVID-19 disruption, on the other hand, must now resume their focus fuelled by a new sense of urgency. Finding an available submission slot with the new target authority is likely to become increasingly challenging the closer we get to the end of the year, so the pressure is mounting.
There are also implications for pharmacovigilance operations. Where UK activities have previously been covered by a qualified person (QPPV) on mainland Europe, the UK will now need its own equivalent, located nationally and reporting to a domestic equivalent of the European EudraVigilance system (for managing and analysing information on suspected adverse reactions to medicines authorised or being studied in clinical trials in the territory).
Although this last requirement has seen the deadline pushed back until 2021, the mandate stands and companies will need to take action now to line up the right person and establish the right systems and processes on the UK side of the border.
Pharmaceutical companies are likely to need help with at least some of this – whether with reframing the regulatory strategy for their products and marketing authorisation, gaining detailed insights into the specific import requirements for each country, managing package variations or authority submissions, or simply supplementing resources to cope with the scale of change project triggered by Brexit.
Practical next steps
As the year-end looms larger, the following checklist may prove useful as organisations review their current status and determine next steps – to ensure they do not run into delays or gaps in supply as the Brexit transition period draws to a close:
* Submit an application to change the location of EU product registration/authorisation, if this has previously been in the UK, to a continuing member state. This should be a priority as authority submission slots will grow scarcer as the end-of-year deadline nears
* Find/appoint/train a QPPV specifically for the UK market – distinct from the qualified person serving the EU – and establish an operation and system for UK-based pharmacovigilance reporting to whatever the national equivalent of the EU EudraVigilance database will be
* Check for potential supply-chain issues as import licences and special documents become a requirement. This will be important to maintain continuity of supply, and minimise the risk of products becoming stuck in a warehouse somewhere, due to insufficient paperwork or non-compliant labelling.
In such a persistently uncertain climate, and at a time when the reliable supply of medicines has never been more critical to public health internationally, life sciences organisations cannot afford to leave anything to chance when it comes to maintaining product availability across all markets. Now that time really is running out to set the right changes in motion, companies must take action to shore up their pipelines.
Cecilia Avram is senior regulatory affairs manager at Arriello
