EMA survey identifies gaps in pharma industry’s preparedness for Brexit
pharmafile | July 11, 2018 | News story | Research and Development | CAPS, EEA, EMA, brexit, preparedness
An EMA survey has identified gaps in the pharmaceutical industry’s preparedness for Brexit, finding that only 58% of market authorisation holders are on track with their regulatory planning in preparation for the UK’s exit from the European Union in March 2019.
The survey, aimed at identifying centrally authorised products (CAPs) that are at risk of shortages following Brexit, identified that for 16% of the medicines surveyed, there are serious concerns the necessary procedures will not be carried out in time.
Marketing authorisation holders must take measures to ensure that the qualified person for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) are located in the European Economic Area (EEA).
According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites must be located within the EEA in order for companies to be able to market medicines in the European Union. Marketing authorisation holders must also take into account potential changes to their logistics, manufacturing sites, contracts and supply chains.
Serious concerns were raised in regards to 108 separate medicines of which 88 were human products and 20 were veterinary products. The EMA will now assess those cases in which there is serious risk of supply shortages as it works to address these risks as early as possible and discuss relevant mitigation measures.
Louis Goss
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