EMA Sees Gaps in Pharma’s Readiness for Brexit

Marketing authorization holders (MAHs) for 58% of the 694 centrally authorized products (CAPs) involving an important regulatory step in the United Kingdom (UK) are on track to ensure that their marketing authorization remains valid following the UK’s withdrawal from the European Union (EU), a recent survey by the European Medicines Agency (EMA) noted in a press releaseon July 10, 2018. Such preparation is crucial to ensuring the continuous supply of human and veterinary medicines after the UK leaves the EU. Companies have been informed since May 2017 of the need to take action, and the European Commission and EMA have regularly sent out information notices on legal issues as well as guidance on practical and simplified requirements. 

Once of the consequences of Brexit is that there may be changes required to the marketing authorization itself, for example, a transfer of the marketing authorization to a legal entity established in the European Economic Area (EEA), or a change of the qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) to a location in the EEA, as well as adaptations to their logistics, manufacturing sites, supply chains, and contracts.

EMA, however, has serious concerns that for 108 (88 human products and 20 veterinary products), or 16%, of these medicines with manufacturing sites located in the UK only, the necessary measures will not be carried out in time. According to EMA, there was no feedback from companies for 10% of the products included in the survey.

The survey was launched in January 2018 to identify CAPS that are potentially at risk of supply shortages and to obtain information on the industry’s progress in making to the necessary regulatory adjustments. The survey was sent to MAHs of the 694 CAPs (661 human and 33 veterinary products) who are located in the UK or who have quality control, batch release, and/or import or manufacturing sites, or a QPPV or PSMF in the UK. EU laws requires the MAH, the QPPV, the PSMF, and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU. 

EMA said that it has reached out to MAHs who either did not reply to the survey or have indicated in the survey that they do not plan to submit the changes required by March 30, 2019 and have manufacturing sites in the UK only, as this could cause potential supply disruptions. EMA isidentifying medicines at risks of supply shortages and will work together with the relevant MAHs to address these risks early and discuss mitigation measures. 

There will be ongoing monitoring of the submission of changes to marketing authorizations for all 694 products to check if the relevant variations/notifications are being submitted. Companies who have not yet informed EMA of their Brexit preparedness plans have been urged to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU. EMA stressed the importance of planning for the UK’swithdrawal from the EU on March 29, 2019 and companies are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated Q+As and practical guidance for industry published on June 19, 2018.

Source: EMA