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Regulations & EHS&S



EMA redistributes UK centralized authorized products in anticipation of Brexit


19/04/2018

The European Medicines Agency (EMA) has reallocated the medicines for the UK’s portfolio of centrally authorized products in anticipation of Brexit, the UK’s withdrawal from the European Union (EU). Over 370 centrally authorized products have been transferred to new rapporteurs and co-rapporteurs from the EU 27 member states, plus Iceland and Norway.

The EU 27 member states and the EMA have completed the reallocation of the medicines for which the UK’s Medicines and Healthcare products Regulatory Agency and Veterinary Medicines Directorate are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine. The new (co)-rapporteurships will be communicated to the relevant marketing authorization holders before the end of April 2018.

The redistribution plan covers the post-authorization stage in a medicine’s lifecycle, i.e. once a medicine has a marketing authorization. The redistribution plan allows member states to participate in EMA activities according to their individual capacity. The methodology used for the reallocation of medicines is based on member states’ current expertise with a specific class of medicines. It also builds on existing knowledge, for example, by transferring medicines to the current co-rapporteur for a particular product, or to the peer reviewer involved in the marketing authorization application.

In addition, the reallocation methodology takes into account the type of product. Generic medicines, for example, were allocated to national competent authorities who traditionally have participated less in EMA evaluations but have indicated that they would like to increase their involvement with such medicines. Clusters of products with the same international non-proprietary name and/or belonging to the same marketing authorization holder have been allocated to a single rapporteur in order to facilitate review of post-authorization procedures and improve efficiency within the network.

The EMA will facilitate the transfer of knowledge on the specific medicines from the UK to the new rapporteurs and co-rapporteurs once marketing authorizations holders have been informed of the changes. The new rapporteurs and co-rapporteurs will only take full responsibility for the re-allocated products as of March 30, 2019, when the UK withdraws from the European Union, and it becomes a third country.