Home » EMA Urges Sponsors to Submit Minor Marketing Authorization Changes by March 29
EMA Urges Sponsors to Submit Minor Marketing Authorization Changes by March 29
The EMA called on drug sponsors to prepare for a surge in minor marketing authorization change submissions in the next three months as companies prepare for the UK’s scheduled exit from the EU on March 29.
To avoid a pileup of submissions on Brexit day, sponsors should file minor Brexit-related variations well in advance of March 29 so that marketing authorization holders can confirm their compliance with regulatory and legal requirements before the UK’s exit.
The agency foresees a significant increase — over 50 percent — in the number of Type I variations in the next three months as companies submit Brexit-related changes to their marketing authorizations.
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