Deadline to nominate a UK National Contact Person – 1st January 2022
The 1st of January 2022 not only marks the start of the new year, it also marks the end of the grace period for EU based UK QPPVs to register a UK based National Contact Person. This is provided for in regulation 182 of the Human Medicines Regulations 2012.
With less than a month to go, time is running out to remain compliant!
UK wide licenses (GB+NI) are required by European and UK law to have an EU QPPV registered with the EMA and a UK QPPV registered with the MHRA. This is due to the competent authorities sharing jurisdiction of Northern Ireland. The regulations stipulate that a QPPV residing in the UK may only act as a UK QPPV however, a QPPV residing in the EU/EEA may act as both a UK and EU QPPV.
If you are a UK Market Authorisation Holder with a QPPV based in the EU, it will be a legal requirement to have a UK National Contact Person (NCP) registered with the MHRA. Failure to do so will mean you will no longer be able to market the product in the UK.
National Contact Person Responsibilities:
If your QPPV resides and operates in the EU/EEA it is essential to nominate a National Contact Person who resides in the UK as soon as possible. This NCP must:
- Be registered with the MHRA through the MHRA Submissions Portal.
- Have access to the reports of suspected adverse reactions associated with the MA.
- Have access to the Pharmacovigilance System Master File.
- Be able to facilitate responses to queries raised by the MHRA, including via inspection
- Reside and operate within the UK.
Each individual UK MA requires a nominated NCP however, one NCP can be registered for multiple MAs.
The UK QPPV remains responsible for the overall maintenance of the product’s pharmacovigilance system, including maintenance of the PSMF.
For UK Marketing Authorisation Holders with a QPPV based within the UK, there is no need to elect an NCP.
The experienced pharmacovigilance team at JensonR+ are perfectly placed to offer NCP services, guiding you through every step of registration and ensuring you remain compliant in time for the change.
Choosing JensonR+ gives you access to their team of in-house pharmacovigilance experts and dedicated UK and EU QPPVs, helping you stay ahead of future regulation changes.
To find out more contact email@example.com.
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