By FDA – Press releases
Marketing authorization holders (MAHs) must have a robust pharmacovigilance (PV) system in place to ensure the safety of their products. When implementing the PV system in European member states, MAHs are required to designate the European Qualified Person Responsible for Pharmacovigilance (EU QPPV) who will be responsible for establishing and maintaining the PV system.
In addition to the EU QPPV, some National Competent Authorities (NCAs) of the EU Member States require MAHs to adjunct a local pharmacovigilance contact person at national level, also known as a Local Contact Person for Pharmacovigilance (LCPPV), also referred to as LPPV or Local QPPV.
We are pleased to present our comprehensive guide which sheds light on the requirements for MAHs to appoint a local person for pharmacovigilance at national level in EU, UK and Switzerland.