The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc. Let us have a look at what Brexit means for the EU and the UK Regulatory Submissions. Here is a clear-cut Brexit impact summary that has recently been published by a consulting firm.
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UK |
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New Marketing Authorization Applications for Centrally Authorized Products (CAPs) |
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New Marketing Authorizations for Mutual Recognition Procedure (MRP)/Decentralized Procedure (DCP) |
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Existing Marketing Authorizations |
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Batch Testing and QP Certification |
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Batch Testing for Products Manufactured in the EU/EEA |
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Batch Testing for Products Manufactured in a Third Country with no MRA with the EU |
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Access to Eudravigilance |
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GMP and GDP |
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Ref: https://www.nsf.org/consulting/health
With a lot of changes expected to be developed in the UK and the EU post-Brexit, it is essential to keep a tab on the upcoming Regulations. You can also reach out to a partner with high-level Regulatory and operational expertise to navigate the changes in the Regulatory landscape. Stay informed. Stay updated.
