Brexit Withdrawal Signed Ahead of UK’s 31 January Departure

Regulatory NewsRegulatory News | 24 January 2020 |  By 

Presidents of the European Commission and European Council and UK Prime Minister Boris Johnson on Friday signed a withdrawal agreement that will see the UK continue to follow EU rules through the end of the year while seeking a deal for future ties with the EU.
The European Parliament is scheduled to vote on the deal on 29 January. The agreement is expected to sail through the European Parliament after its Constitutional Affairs Committee voted in favor of the agreement in a 23-3 vote on Thursday. Once the agreement has cleared the Parliament, the Council will adopt the agreement and it will enter into force on 31 January.
For the time being, the signing of the withdrawal agreement should relieve some anxiety over a “no deal” Brexit.
However, even with a withdrawal agreement in place, the UK and EU will need to secure a deal on their future relations before the transition period outlined in the withdrawal agreement ends on 31 December 2020.
For the time being, drugmakers will still need to ensure they meet the EU’s legal and regulatory requirements for medicines once the UK has left the EU. The European Medicines Agency (EMA) and the European Commission have provided a collection of guidance documents for drugmakers to follow to ensure their products are in compliance post-Brexit.
For the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has compiled a set of guidance documents and publications covering drug and medical device regulation in the UK in the event that a Brexit deal is not reached.
For medical devices and in vitro diagnostics, the current EU directives will still apply to the UK via the UK’s Medical Devices Regulations 2002 as amended by The Medical Devices (Amendments etc.) (EU Exit) Regulations 2019, which also transposes the upcoming EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) into UK law.
The UK also prepared a set of recommendations for the life sciences sector on preparing for Brexit, including advice on marketing products in the EU/European Economic Area and UK, importing and exporting goods and explaining that the UK will continue to recognize existing clinical trial authorizations.
While the exact shape of an agreement on future relations between the EU and UK remains uncertain, the Association of the British Pharmaceutical Industry (ABPI) has pressed for the UK to “negotiate alignment and commonality with the EU for the regulation of medicines.”
Baroness Brinton in the House of Lords made the case last week during negotiations that if the UK leaves the European medicines regulatory network, it will be leaving a body that constitutes 25% of the global pharmaceutical market, to be a stand-alone country making up only 3% of that market. 
“Pharmaceutical companies will have to submit separate applications to the MHRA to gain UK marketing rights. Evidence shows that countries such as Switzerland, Canada and Australia all receive applications for drug licensing after the EMA, with an average delay of six months,” she noted.
European Council


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