Requirements for Eudra Vigilance
The current process is dependent on its access to several EU databases and centralised systems, e.g. EudraVigilance. It is likely that the UK will no longer have access to these Post-Brexit, so new centralised reporting requirements started in November 2017. The UK may have to have its own system. Also UK-based Qualified Persons Responsible for Pharmacovigilance (QPPVs) will probably no longer be eligible to practice in the EU.
- According to Article 8 of Directive 2001/83/EC and Article 74 of Directive 2001/82/EC, the qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in a Member State of the Union (EEA).
- According to Commission Implementing Regulation (EU) No 520/2012, the PSMF must be located within the Union (EEA)
PharmaConsult will provide the EU QPPVs –who will work in close association with their UK counterparts, but after Brexit only entities based in the EU/EEA can have access to EudraVigilance, EVDAS and other EU safety databases to report and collect safety information and will represent the UK company and in generating a legal entity who will be accountable for the PSMF for all your EU products