News about GMP/cGMP

26.01.2018

EMA: Survey for Pharma Companies on Brexit-Preparedness

The European Medicines Agency (EMA) has launched a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the United Kingdom (UK), or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the UK’s withdrawal from the European Union (EU).

Figures published with the survey information for human medicines show that more than a ⅓ (427/1165) of centrally authorized products on the EU market are made by UK-based drugmakers, and more than a ¼ of centrally authorized products have a qualified person for pharmacovigilance (QPPV) based in the UK. EMA also says that 18% of the small and medium-sized enterprises registered with the agency are based in the UK.