On March 29th 2019, the UK becomes a “third country” from the EU, and will transition to a new relationship. The impact of Brexit on the pharmaceutical industry continues to evolve, but UK companies who develop or supply product for sale or clinical use in the EU/EEA will likely face regulatory complexity, added costs, disruption in their supply of raw materials and finished-goods, and risk long-term loss of revenue and customers.
The European Medicines Agency (EMA) is currently headquartered in London, but as a consequence of Brexit will be transitioning to a new home in Amsterdam by January 2019. Post-Brexit, slower marketing approval of drugs in the UK is expected regardless of what deal, if any, is implemented. The UK government is hoping to retain an arrangement almost identical to the current situation for drug approvals. However, the European Union has indicated they will not accept such an arrangement following the departure of the UK from the union. With uncertainty remaining over the final state, as well as the likelihood of a final agreement that is inferior to the current state, it is unsurprising that drug approval and regulatory issues are posing major concerns for pharmaceutical companies.
What we know so far is that, after March 29th 2019, the following will occur:
• Marketing Authorisation (MA) holders, if held in UK, will have to be transferred to an EU or EEA country.
• Each consignment of UK-manufactured Active Pharmaceutical Ingredients (APIs) to the EU/EEA needs to be accompanied by an MHRA certificate of conformation to EU GMPs.
• Each batch of drug product will need to be released by a QP within the EU/EEA.
• Pharmacovigilance will need to be managed from a location within the EU/EEA.
• There will no longer be unrestricted transport of goods between the EU and the UK.
• Expect added paperwork, transport delays, and likely customs duties.
HiTech Health has developed a range of strategies to enable healthcare companies to successfully navigate Brexit. Our support will be tailored to your company’s needs. Please email us at email@example.com to request further information on the range of services we can provide.
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