Glossary · GxP: good practices
Good pharmacovigilance practices (GVP)
Also known as: GVP, EU GVP, Guideline on good pharmacovigilance practices
Good pharmacovigilance practices (GVP) are the EU guidelines, organized in modules, on how marketing authorization holders, EMA and national authorities detect, assess, understand and prevent adverse effects of medicinal products. Their legal basis is Regulation (EC) No 726/2004, Directive 2001/83/EC and Implementing Regulation (EU) No 520/2012.
- GxP
- Pharma
- EU
In one sentence
GVP are the EU pharmacovigilance guidelines, in modules, for detecting and assessing adverse effects of authorized medicines.
Example
A marketing authorization holder keeps a pharmacovigilance system master file, has a qualified person responsible for pharmacovigilance, submits individual case safety reports and prepares periodic safety update reports as its GVP procedures require.
How it applies
- Modules: GVP is split into modules on processes such as the pharmacovigilance system and its quality system, the pharmacovigilance system master file, risk management plans, adverse reaction reporting, periodic safety update reports and signal management.
- Roles: The marketing authorization holder must have a qualified person responsible for pharmacovigilance (QPPV) in the EU. This role differs from the batch-release Qualified Person.
- Combination products: For drug-device combinations regulated as medicinal products, adverse events run through pharmacovigilance; events concerning a separately marketed device run through device vigilance.
- Technical documentation: Case reports, signal assessments, risk management plans and PSURs are the evidence; the master file describes the system and must be kept current.
GVP vs. device vigilance
GVP concerns medicinal products after authorization and covers adverse reactions, signal detection and benefit-risk reassessment. Vigilance under the MDR and IVDR concerns serious incidents and field safety corrective actions for devices, with fixed reporting deadlines in Article 87 MDR. Both use the term PSUR, but the device PSUR under Article 86 MDR is a different document from the pharmacovigilance PSUR.