Post-Brexit medicines supply continuity: critical adaptations
SummaryEarlier this year the European Medicines Agency updated its guidelines, clarifying how to maintain supply of UK-registered products in Europe following December 31. Here, Cecilia Avram, Senior Regulatory Affairs Manager at Arriello, assesses what needs to change.
- Author Company: Cecilia Avram
- Author Name: Arriello
Earlier this year the European Medicines Agency updated its guidelines, clarifying how to maintain supply of UK-registered products in Europe following December 31. Here, Cecilia Avram, Senior Regulatory Affairs Manager at Arriello, assesses what needs to change.
After months of Covid-related distractions, Brexit is back in the headlines - demanding new attention to how the life sciences industry will maintain cross-border product movement and manage regulatory administration from January 1. Updated guidelines for pharmaceuticals marketing authorisation holders (MAHs) were published by EMA in March. Below is a summary of the main changes.
If UK product registrations have been managed 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.
For affected MAHs, switching authorities/procedures could necessitate the submission of variations, as UK-marketed products become nationally registered. From January, the MHRA is likely to have established its own set of rules applicable for new national procedures.
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 vice versa.
Meanwhile, 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.
As of 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 EU 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.
What to do now
All of this will translate to additional complexity, administration, cost and delay along the supply chain. Proactive organisations may have already switched competent authority in anticipation of the end to the Brexit transition period. Others now need to step things up a gear: securing a submission slot with the new target authority will be increasingly challenging as the end of the year nears.
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. Although companies now have until 2021 to organise this, it will take time 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, especially as the year-end draws near. Here’s a quick summary of immediate priorities:
1. Submit an application to change the location of EU product registration/authorisation, if previously in the UK, to a continuing member state.
2. 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 PV reporting.
3. Check for potential supply-chain issues as import licences and special documents become a requirement.
About the author
Cecilia Avram is Senior Regulatory Affairs Manager at Arriello, a global provider of innovative, high-impact market access, regulatory affairs & pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.