In Europe in 2012, new legislation for pharmacovigilance was implemented which expanded on and clarified previous legislation.
New Regulation no. 1235/2010 and Directive 2010/84/EU were published and underpinned by the EC Implementing Measures Regulation no. 520/2012.
In addition a series of 16 modules on GVP were developed by the EMA to guide marketing authorisation holders on the implementation of the new legislation.
The basis of the new regulations is that quality systems should form an integral part of the pharmacovigilance system to ensure effective monitoring of compliance and the accurate and proper documentation of all measure taken.
The ultimate objective is the protection of patients.
We can introduce you to our established network of PV providers, who can help you pro-fill your safety needs.