EMA Urges Sponsors to Submit Minor Marketing Authorization Changes by March 29

March 5, 2019

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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