European Union Finalizes Reallocation of United Kingdom's Medicines Portfolio

The European Union and the European Medicines Agency (EMA) recently announced completion of the reallocation of the United Kingdom’s duties for evaluating medicines.

According to the reallocation report, over 370 centrally authorized products have been transferred to new rapporteurs located in the remaining 27 EU member states, Iceland, and Norway. The transfer followed a procedure developed by the EMA’s working groups on committees’ operational preparedness for both human and veterinary medicines in the wake of the United Kingdom’s withdrawal from the European Union.

The redistribution plan applies to medicines that have already been granted marketing authorization, and, according to the EMA, “follows a multifaceted approach and takes into account both the diverse expertise in the European medicines regulatory network and the workload associated with each medicine.”

The following principles were utilized by the EMA Management Board to guide the redistribution of the product portfolio:

• Ensuring business continuity
• Retaining knowledge
• Allowing compliance with legally required timelines
• Ease of implementation and sustainability
• Allowing all National Competent Authorities (NCAs) to participate in EMA activities in accordance with their capabilities

The approach used for the redistribution of medicines was based on member states’ knowledge and expertise with specific classes of medicines. In addition, the transfer process also took into account the type of product that was being reallocated. For example, generic medicines were allocated to NCAs that have indicated that they would like increased involvement with evaluating such medicines.

Finally, groups of products with the same international non-propriety name, or products that belong to the same marketing authorization holder, have been reallocated to a single rapporteur in order to efficiently facilitate the review of post-authorization procedures.

The identities of the new rapporteurs will be communicated to the marketing authorization holders by the end of April 2018, and the rapporteurs will take full responsibility of the newly transferred products as of March 30, 2019, when the United Kingdom officially withdraws from the European Union.