GVP – Annex I: Definitions

REVISION 5 in force from: 6. 8. 2024

Definitions

Abuse of a medicinal product
Active substance
Advanced therapy medicinal product (ATMP)
Adverse event (AE)
Adverse event following immunisation (AEFI)
Adverse reaction; synonyms: Adverse drug reaction (ADR), Suspected adverse (drug) reaction, Adverse effect, Undesirable effect
Audit
Audit finding(s)
Audit plan
Audit programme
Audit recommendation
Biological medicinal product
Biosimilar medicinal product
Clinical study
Clinical trial
Closed signal
Company core data sheet (CCDS)
Company core safety information (CCSI)
Compassionate use of a medicinal product
Completed clinical trial
Confirmed signal
Consumer
Crisis
Data lock point
Development international birth date (DIBD)
Development safety update report (DSUR)
Direct healthcare professional communication (DHPC)
Disease registry
Emerging safety issue
EU reference date; synonym: Union reference date
Excipient
Failure to vaccinate
Falsified medicinal product
Generic medicinal product
Good pharmacovigilance practices (GVP) for the European Union (EU-GVP)
Healthcare professional
Herbal medicinal product
Homeopathic medicinal product
Identified risk
Illegal purposes
Immunisation
Immunisation anxiety-related reaction
Immunisation error-related reaction
Immunisation stress-related response (ISRR)
Immunological medicinal product
Important identified risk and Important potential risk
Important potential risk
Incident
Individual case safety report (ICSR); synonym: Adverse (drug) reaction report, Suspected adverse (drug) reaction report
International birth date (IBD)
Investigational drug
Investigational medicinal product
Labellinge
Low-intervention clinical trial
Medical device
Medication error
Medicinal product
Medicinal product derived from human blood or human plasma
Minimum criteria for reporting
Missing information
Misuse of a medicinal product
Misuse of a medicinal product for illegal purposes
Name of the medicinal product
Named patient use
Newly identified signal
Non-confirmed signal
Non-interventional study
Non-validated signal
Normal clinical practice
Occupational exposure to a medicinal product
Off-label use
Ongoing clinical trial
Ongoing signal
Overdose
Package leaflet
Patient
Patient registry; synonym: Registry
Periodic safety update report (PSUR)
Pharmacovigilance
Pharmacovigilance system
Pharmacovigilance system master file (PSMF)
Post-authorisation safety study (PASS)
Potential risk
Primary data collection
Quality adherence
Quality assurance
Quality control and assurance
Quality improvements
Quality objectives
Quality of a pharmacovigilance system
Quality planning
Quality requirements
Quality system of a pharmacovigilance system
Reference safety information
Registry database; synonym: Register
Refuted signal
Registry-based study
Risk management plan (RMP)
Risk management system
Risk-benefit balance
Risk minimisation measure (RMM); synonym: Risk minimisation activity
Risks related to use of a medicinal product
Safety concern
Secondary use of data
Serious adverse reaction
Signal
Signal analysis and prioritisation by the PRAC
Signal assessment
Signal confirmation by the PRAC Rapporteur or (lead) Member State
Signal detection
Signal management process
Signal prioritisation
Signal validation
Solicited sources of individual case safety reports
Spontaneous report, synonym: Spontaneous notification
Stimulated reporting
Substance
Strength of the medicinal product
Summary of product characteristics (SmPC)
Target population (risk minimisation measure)
Target population (treatment); synonym: Treatment target population
Target population (vaccine); synonym: Vaccine target population
Traditional herbal medicinal product
Unexpected adverse reaction
Upper management
Vaccination
Vaccination failure
Vaccine
Vaccine failure
Vaccine pharmacovigilance
Vaccine product-related reaction
Vaccine quality defect-related reaction
Valid individual case safety report
Validated signal