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Home › Forums › Pharmacovigilance Forum › EU QPPV UK
Hi,
We have a question regarding the changing of the EU QPPV. We know that you have to submit variations for each single licence, how is it feasible if you have over 100s of license’s. There must be a easier way of notifying EU QPPV change?
Thanks,
Dear PIPA Member,
Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.
If you need to submit the same change on many licences you can approach the MHRA to discuss filing strategy for these variations. The email address is: variationqueries@mhra.gov.uk
Kind regards
PIPA
Thanks for your reply and letting us know.
Has anyone on here did this before where they have over 100 licenses and were able to notify MHRA in one go rather then sending the variations in batch of 10 for example the new EU QPPV?
Thanks
Dear PIPA Member,
Unfortunately, no one on the committee has had to do this before therefore, we are unable to advise further.
Kind regards
PIPA
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