European Union: BREXIT Update: European Medicines Agency (EMA) Redistributes UK's Portfolio Of Centrally Authorized Products

On April 11, 2018, the European Union's 27 Member States and the European Medicines Agency (EMA) announced that they 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 medicine20. Over 370 centrally authorized products have been transferred to new rapporteurs and co-rapporteurs from the 27 EU Member States, plus Iceland and Norway, following a methodology developed by EMA's working groups on committees' operational preparedness for human and veterinary medicines. EMA will inform the relevant marketing authorisztion holders of the new (co)-rapporteurships by the end of April 2018. EMA will also facilitate knowledge transfer from the UK to the new rapporteurs and co-rapporteurs, who will only take full responsibility for these products as of March 30, 2019.

Brexit Background                                                                                                               

The United Kingdom submitted on March 29, 2017, the notification of its intention to withdraw from the European Union pursuant to Article 50 of the Treaty on European Union. This means that unless a ratified withdrawal agreement establishes another date, all primary and secondary Union laws cease to apply to the United Kingdom from March 30, 2019, 00:00h (CET). The United Kingdom will then become a 'third country'. EMA will move its headquarters from London to Amsterdam post BREXIT. Consequent to UK's exit, the MHRA and VMD will no longer be able to engage in centralized regulatory procedures, as (Co)-Rapporteurs, which are expected to finalize after March 30, 2019.

Redistribution plan of the UK centrally authorized product portfolio                                    

The redistribution plan covers the post-authorization stage in a medicine's lifecycle, i.e. once a medicine has a marketing authorization. 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 capacity21.

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 (INN) 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 ultimately improve efficiency within the network.

General principles                                                                                                                

The general principles, adopted by the EMA Management Board, to guide the redistribution of the UK product portfolio were to:

  • ensure business continuity;
  •  ensure knowledge retention, either building on existing knowledge, or through knowledge transfer;
  • allow compliance with the legally required timelines and to maintain the quality of the output;
  • be as easy as possible to implement and, in addition, to be sustainable;
  • strive to allow all NCAs to participate in EMA activities, as per the capacity and capability of each NCA, so as to ensure an optimized and robust allocation of the workload across the Network

What is Centralized Authorization Procedure?                                                                      

In the European Union under the centralized authorization procedure, pharmaceutical companies submit a single marketing-authorization application to EMA. This allows the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization. EMA's Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not. Once granted by the European Commission, the centralized marketing authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway22.

Conclusion:                                                                                                                          

With the United Kingdom's (UK) scheduled exit from the European Union in about 12 months, the European Medicines Agency has reassigned overseeing of UK agencies viz. MHRA and VMD's products to the other 27 member states, plus Iceland and Norway.

Footnotes

20 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/04/news_detail_002937.jsp&mid=WC0b01ac058004d5c1

21 http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/04/WC500247359.pdf

22 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000109.jsp&mid=WC0b01ac0580028a47

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