EMA Urges Sponsors to Prep for Spike in Brexit-related Submissions

Regulatory NewsRegulatory News | 27 February 2019 |  By 

The European Medicines Agency (EMA) urged marketing authorization holders (MAHs) looking to make Brexit-related changes in March to do so “as early as possible during the month,” citing a 50% expected increase in the number of marketing authorization changes over the next three months.

EMA’s notice—posted on Tuesday—calls on MAHs that intend to submit Brexit-related Type IA and Type IB variations next month to do so well before the 29 March deadline for Britain to leave the EU.

“This will enable EMA to process the submissions before 29 March so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before this date,” the agency said.

Sponsors making changes to the terms of a marketing authorization that have little to no impact on the quality, safety or efficacy of the medical product—otherwise known as Type I variations—should submit these immediately after their implementation so EMA can ensure continuous supervision. EMA must be notified prior to implementation of such minor changes, though they do not require formal approval.

The notice applies to Brexit-related Type I variations such as “changes to sites responsible for batch release, physical importation, batch control testing of finished product and update of CE marking document for medical devices co-packaged with medicinal products.” EMA recommends MAHs use the prenotification checklists for either Type IA or Type IB variations and follow a 2017 procedural guidance on Brexit-related variations, which EMA last updated earlier this month.

“Most MAHs have shared their plans for the submission of Brexit-related post-authorization changes with EMA,” the agency said. The notice comes after EMA established a simplified transfer process for some MAHs impacted by Brexit. Yet it also comes amid an expected staff loss at EMA of about 25%.


To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.


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