Out-Law News | 20 Jun 2018 | 3:26 pm | 2 min. read
Dublin-based Karen Gallagher of Pinsent Masons, the law firm behind Out-Law.com, said new guidance issued by the European Medicines Agency (EMA) and the European Commission highlighted the increasing focus being given to the "practical implications" of the UK's withdrawal from the EU for businesses in the pharmaceutical sector by both the companies themselves and regulators.
She said the guidance should prompt pharmaceutical companies to "take positive steps now to prepare for a situation whereby the UK becomes a third country on 30 March 2019".
According to a new 'question and answer' paper (10-page / 577KB PDF) issued by the EMA and Commission, UK-based pharmaceutical companies will be unable to rely on marketing authorisations (MAs) issued by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to sell their products across the EU after Brexit.
Gallagher said: "EU law requires that MA holders of centrally authorised medicinal products for human and veterinary use are established in the EEA, and that pharmacovigilance and batch release processes are carried out within the EEA by persons established in the EEA. Following Brexit, active substances manufactured in the UK will be treated as imported active substances, and will have to be manufactured in compliance with EU standards of good manufacturing practice. In addition, companies manufacturing finished products in the UK will need a site of batch control within the EEA."
"The EMA expects UK-based MA holders to take steps before 30 March to make any necessary changes to their existing marketing authorisations or applications and/or transfer them to holders located in the EU. In addition, UK based pharma companies without an alternative EU base will need to transfer some or all of their operations to an EU member state," she said.
With those requirements in mind, UK-based pharmaceuticals could consider setting up operations in Ireland to maintain their links into the EU market after Brexit, Gallagher said.
She said: "The Health Products Regulatory Authority (HPRA) in Ireland issued its own Brexit guidance document in January 2018. In recognition of the central role Ireland is likely to play for UK pharma companies requiring an EU base, the HPRA has highlighted that it is 'willing and prepared' to take over the role of reference member state for such companies, and that it is ready to work with companies who need to transfer operations to Ireland in order to access the EU market."
"The HPRA has also said that it plans to continue to work with the UK after Brexit to help to maintain dual labelling for products sold on both the UK and Irish markets, where possible. The updated EMA guidance confirms that the use of multi-country packs will only be possible in circumstances where the product labelling and package leaflet are fully in line with EU requirements, as EU law requires the summary of product characteristics to be the same in all markets," Gallagher said.
According to Gallagher, it is likely that the issues addressed in the new guidance will form part of Brexit negotiations between the UK and EU27.
"The pharmaceutical sector is hugely valuable to Ireland, and it is clear from public statements made by both the HPRA and the Department of Business, Enterprise and Innovation that they are determined that Ireland and the UK should work together to facilitate the continued growth of this thriving sector in both countries," Gallagher said.