Pharmaceutical companies must consider whole supply chain when assessing implications of Brexit, says expert

Catherine Drew of Pinsent Masons, the law firm behind Out-Law.com, said such a mapping exercise is a necessary first step for UK-based pharmaceutical companies that could find it necessary to make changes to their corporate structures as a result of Brexit.

Drew was commenting after new guidance issued by the European Medicines Agency (EMA) and European Commission confirmed that UK-based pharmaceutical companies will be required to transfer their marketing authorisations for their medicines to entities located in another EU country when Brexit takes effect.

Drew said the guidance was to be welcomed as it highlighted that pharmaceutical companies need to think beyond ensuring that marketing authorisations held by UK-based entities currently are moved to a entity based in another EU country ahead of Brexit.

According to the guidance, UK-based pharmaceutical companies must ensure that they transfer orphan designations for medicinal products to EU-based entities. They must also ensure that the person responsible for ensuring product safety standards are met – known as a qualified person for pharmacovigilance (QPPV) – lives and works within the European Economic Area, it said.

The guidance also confirmed that the document pharmaceutical companies are obliged to maintain setting out their product safety measures – the pharmacovigilance system master file (PSMF) – is kept within the EEA.

The EMA and Commission also explained that, post-Brexit, pharmaceutical companies wishing to import components of biological medicines into the EU from the UK will need to obtain written certification from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) that the standards of UK manufacturing "are equivalent" to the standards required in the EU.

The authorities also made clear that pharmaceutical companies will need to obtain authorisation from EU-based regulators to import medicinal products made in the UK into the EU. The imported products will also be subject to EU testing procedures, according to the guide.

"The marketing authorisation holder will need to specify a site of batch control in the Union (EEA) where each production batch can undergo upon importation a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation," it said.

The guidance further confirmed that UK-based batch release sites will need to be transferred to a location within the EU.

"This guidance illustrates that whilst companies need to think about the more obvious questions around where their marketing authorisations are held and where their QPPV resides, they will also need to consider manufacturing sites, batch control and batch release sites," Drew said. "In short this is not a simple process, but one which will likely be rather time consuming and potentially complex." 

"Practically speaking, to hope to complete the required activities by the date upon which the UK leaves Europe, companies need to start thinking now about what marketing authorisations are held and where and map these in addition to their full manufacturing and supply chain. Once that activity is complete then the task of moving the pieces of the jigsaw puzzle can commence," she said.

According to the EMA, pharmaceutical companies can expect further Brexit-related guidance to be issued "in due course".