PJI Biotech 

PJI Biotech

  Strategic Quality and Regulatory Management Consulting

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Brexit on Horizon

Posted on October 26, 2018 at 12:45 AM
We have been hearing about Brexit for quite some time. Brexit is impacting the life science industry in the UK and EU in several ways but mainly by causing regulatory uncertainty and patient access to medicine or supply chain impact. EMA issued a guidance on 24 November 2017, for market authorization holders to transfer current UK based market authorizations (MA) to different legal entity in EEA, which needs to be completed by March 2019. The MHRA position will be clear after further negotiations but there is a risk of Brexit disrupting the supply chain due to complexities caused by additional importation testing, batch certification and regulatory inspections. It has to be seen how negotiations will end but pharma companies need to be ready with Brexit strategies for supply chain management such as adding additional capacity for MA transfer, batch certifications and additional storage capacity to hold stock during the Brexit transition period.

Categories: Current Regulatory Trends

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