EMA targets Centrally Authorised Marketing Authorisation Holders to assess procedural workload resulting from Brexit

The European Medicines Agency (EMA) has produced targeted surveys for centrally authorised Marketing Authorisation Holders (MAHs) to assess procedural workload resulting from Brexit. Companies are asked to map all the planned changes and submit the completed questionnaire by 9th February 2018.

The aim of the survey is to allow the EMA and European Commission to gather more detailed information regarding the upcoming procedural workload resulting from the United Kingdom’s (UK) withdrawal from the European Union (EU). This will include information such as the number of transfers, variations, notifications of procedural changes of certain activities located in the UK and the planned timing for submission. The survey also aims to identify centrally authorised medicinal products where continuity of supply may be affected and may impact public health within the EU.

Therefore, the information collected from the industry is expected to enable the EMA to make the necessary preparations to ensure that it continues to deliver on its mission and protect public and animal health. The EMA states that they will “make every effort to avoid any potential shortage and supply of centrally authorised medicinal products after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.”

The targeted survey is being sent to both human and veterinary centrally authorised MAHs that have certain activities located in the UK which will be subject to change as the result of the UK’s withdrawal from the EU. These changes could relate, amongst others, to MAH transfers, changes to location of PSMF, QPPV, Orphan Designation or MUMs sponsor/holder and/or certain finish product site(s) changes.

The EMA has said that before completing the survey, it is important that the MAHs contact points responsible for completing the survey reads the ‘Guidance for Industry’ document.

To view the questionnaires, please click on the links below.

 

Brexit Questionnaire 1 – MAH transfers, PSMF, QPPV, Orphan Designation and MUMS (minor use/minor species) changes.

Brexit Questionnaire 2 – Transfer of UK sites for the finished product (batch release, importation, batch control/testing, Official Batch Control).