EMA Brexit preparedness business continuity plan enters third phase

The European Medicines Agency’s (EMA) Brexit preparedness BCP entered into its third phase recently as announced at the beginning of August 2018.

The temporary suspension or reduction of additional activities in this phase allows the agency to safeguard core activities related to the evaluation and supervision of medicines while the agency prepares for the consequences of the United Kingdom’s (UK) exit from the European Union (EU) – both in terms of the impact on the agency’s operations, as well as its physical move to Amsterdam. It will also help the agency cope with anticipated staff loss.

"EMA will now temporarily suspend or scale back additional activities to ensure that resources can be redeployed so that its core activities can continue without interruption and to the same quality," commented Noël Wathion, EMA’s Deputy Executive Director. "Over the next few months, EMA will continue to carefully monitor staff intentions to relocate and the anticipated impact on its activities whilst planning for the critical time period when the agency will be moving to its new premises in Amsterdam," he added.

The measures announced on August 1 included, among others, the scaling back of guideline development and revision and the putting on hold of non-product related working parties from November 1, 2018. The agency has now drawn up priority lists of those guidelines and working parties, which will exceptionally continue during BCP phase three:

 Work on seven guidelines which address either an urgent public/animal health need, or are necessary to support and facilitate preparations for Brexit or the implementation of new or revised legislation, will continue beyond November 1, 2018;

 Meetings of product-related working parties will continue as scheduled;

 All meetings of non-product related working parties have been temporarily put on hold in line with the reduction in the number of guidelines to be processed.

Detailed information is available in the BCP phase three implementation plan.

Practical guidance for companies on cut-off dates for UK rapporteur appointments

EMA has also published new information for pharmaceutical companies on cut-off dates for appointments of (co)-rapporteurs from the UK for both pre- and post-authorisation activities for centrally authorised medicines (CAPs).

In preparation for the UK’s withdrawal from the EU as of March 30, 2019, all medicines for which the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are acting as rapporteurs or co-rapporteurs in centralised procedures will need to be transferred to new rapporteurs and co-rapporteurs from the EU27 member states, plus Iceland and Norway. The cut-off dates were established based on the average length of a specific procedure, from submission to outcome.

For full initial marketing authorisation applications the process is complete and new rapporteurs have been assigned for all CAPs.

For line extensions and extensions of indication, the cut-off dates have already passed and therefore procedures starting after October 1, 2018 will already be taken care of by the new (co)-rapporteurs.

All other post-authorisation procedures will be allocated to new (co)-rapporteurs as follows:

 Quality, safety and efficacy type II variations submitted after October 26, 2018;

 Renewal applications submitted after October 24, 2018;

 Periodic safety update reports (CAPS only) submitted after November 6, 2018;

 Type IB variations submitted after January 16, 2019;

 For veterinary medicines the above cut-off dates apply with the exception of renewals (November 2018) and periodic safety update reports (PSURs) (December 2018).

Companies are reminded to submit their applications for any necessary changes allowing their marketing authorisations to remain valid in the EU, Iceland and Norway after Brexit as soon as possible and in consideration of the procedural timelines foreseen in the regulatory framework.

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