Redistribution of UK’s portfolio of centrally authorised products

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11/04/2018

Redistribution of UK’s portfolio of centrally authorised products

Assignment of new rapporteurs and co-rapporteurs completed

The EU27 Member States and the European Medicines Agency (EMA) have completed the reallocation of the medicines for which the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

Over 370 centrally authorised products have been transferred to new rapporteurs and co-rapporteurs from the EU27 Member States, plus Iceland and Norway, following a methodology developed by EMA’s working groups on committees’ operational preparedness for human and veterinary medicines.

The new (co)-rapporteurships will be communicated to the relevant marketing authorisation holders before the end of April.

The redistribution plan covers the post-authorisation stage in a medicine’s lifecycle, i.e. once a medicine has a marketing authorisation. It 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. It 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 authorisation 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 (INN) and/or belonging to the same marketing authorisation holder have been allocated to a single rapporteur in order to facilitate review of post-authorisation procedures and ultimately improve efficiency within the network.

Further details are explained in a report.

EMA will facilitate the transfer of knowledge on the specific medicines from the UK to the new rapporteurs and co-rapporteurs once marketing authorisation 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 30 March 2019, when the UK withdraws from the European Union and becomes a third country.

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