The recent announcement by Chinese biopharmaceutical company WuXi Biologics of its €325 million development of a manufacturing facility in Dundalk is a great example of Ireland's standing in the life sciences sector.
Ireland is a leading location for companies in the pharmaceutical and medical technology sectors and is therefore a natural hub for businesses in these sectors who wish to expand their presence in the EU-27 remaining member states in preparation for Brexit.
The guidance that has been issued by the European Commision is clear. Given the UK's desire to leave the EU single market and customs union, businesses in these sectors should be preparing on the basis that they will not be able to rely on their UK authorisations to operate in the EU post-Brexit.
In January the European Commission published a notice warning concerning CE marking on industrial products, which will be relevant for companies in the medical devices sector. The notice advises CE mark holders to take steps to ensure that post-Brexit, where applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body. Where economic operators hold certificates issued by a UK Notified Body prior to the Brexit withdrawal date and plan to continue placing the product concerned on the EU-27 market, the notice advises that they consider either applying for a new certificate issued by an EU- 27 Notified Body or arranging for a transfer of the file and corresponding certificate from the UK Notified Body to an EU-27 Notified Body.
With regard to pharmaceutical products, the European Commission has published a Notice (latest version dated 29 January 2018) and practical guidance for Marketing Authorisation Holders (MAHs) on procedures related to Brexit, including procedures for transfer of marketing authorisations from UK based MAHs to MAHs based in the EU-27.
More details on the legal services we can provide to businesses impacted by Brexit or who wish to establish in Ireland can be found on our website:
Chinese biopharma firm to create 400 jobs in Dundalk