Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the consequences of Brexit on the workload of the agency.

In particular, the EMA press release on the meeting reports that the EMA and NCAs agreed on general principles for workload distribution and initiated discussion on a working methodology to ensure continuity and efficiency in the evaluation and monitoring of medicinal products in the EU once the United Kingdom leaves the EU.

The general principles agreed upon for workload distribution include: 

  • Ensuring business continuity;
  • Maintaining the quality and robustness of the scientific assessment;
  • Continuing to comply with legal timelines;
  • Ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer;
  • Assuring an easy implementation and medium- and long-term sustainability. 

The EMA and NCAs have also agreed to establish a working methodology to map out current and future capacity and expertise of NCAs and ensure an optimized and robust allocation of the workload. Potential gaps will be identified with the aim to support the NCAs with enhanced training opportunities.

In parallel, on May 2, 2017, the European Commission issued a notice on Brexit's implications for pharmaceutical companies that hold a centralized marketing authorization in the EU (i.e., a marketing authorization granted by the European Commission and valid in all EU Member States). The notice calls upon these companies to proactively screen their marketing authorizations to identify all variations and transfers necessary in light of Brexit.

Indeed, applicable European Union legislation requires marketing authorization holders to be established in the EU/EEA and to designate a qualified person established in the EU for the purpose of performing pharmacovigilance activities. In these circumstances, the European Commission's notice highlights the importance for concerned companies to take, early-on, all steps necessary to avoid disruption in the supply of their products in the EU. In the notice, the European Commission reiterates its commitment, together with the EMA, to support marketing authorization holders throughout these changes. The notice adds that the European Commission and EMA will provide a series of Q&As and that adequate information will also be provided for products subject to a UK marketing authorization, by the Coordination Group for Mutual Recognition and Decentralized Procedures—human (the "CMDh").

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