On 29th March 2017, the United Kingdom (UK) submitted the notification of its intention to withdraw from the European Union (EU). Therefore, unless a ratified withdrawal agreement establishes another date, all Union primary and secondary law ceases to apply to the UK from 30th March 2019 and the UK will become a ‘third country’. As a consequence the Medicines and Healthcare Products Regulatory Agency (MHRA) will no longer be able to engage in centralised regulatory procedures as (co)-rapporteurs.
The redistribution of the UK centrally authorised product (CAP) portfolio involved the reallocation of UK rapporteurs and co-rapporteurs from European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT).
The EU27 Member States and the EMA have completed the reallocation of the medicines for which the UK’s MHRA are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine. The EMA states that 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 aim is for the new (co)-rapporteurships to be communicated to the relevant marketing authorisation holders before the end of April 2018.
The methods that were used for the reallocation of medicines were based on Member States’ current expertise with a specific class of medicines and build 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. The reallocation methodology also takes into account the type of product. Generic medicines 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, with the aim of improving efficiency within the network.
Once marketing authorisation holders have been informed of the changes, the EMA will facilitate the transfer of knowledge on the specific medicines from the UK to the new rapporteurs and co-rapporteurs. The new rapporteurs and co-rapporteurs will only take full responsibility for the re-allocated products as of 30th March 2019, when the UK withdraws from the EU and becomes a third country.
To read more about the redistribution of the UK’s portfolio of centrally authorised products, and the assignment of new rapporteurs and co-rapporteurs, please click here.