UK Offers Pragmatic Approach To Safety Reporting From Jan 2021
Role Of National Contact Person For Pharmacovigilance Needs More Clarity
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.
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With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.
The Medicines and Healthcare products Regulatory Agency has outlined the various common scenarios that may occur when companies submit a UK pediatric investigation plan after the Brexit transition period has expired.
Guidance from the UK’s MHRA on post-Brexit arrangements relevant to the off-patent industry has been welcomed by local industry body the BGMA. However, it has warned that time is short to prepare for the end of the UK-EU transition period, with new guidance in certain areas “critical.”