Spring Intro 2023

16/02/2023

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Abbreviations AR Assessment Report

PAES PAM PASS

Post-authorisation efficacy study Post-authorisation measure Post-authorisation safety study

B/R CDS

Benefit Risk

Core Datasheet

CHMP

Committee for Medicinal Products for Human Use PDCO

Paediatric Committee

Coordination Group for Mutual Recognition and Decentralized Procedures (Human)

CMDh

PhV

Pharmacovigilance

CMS

Concerned Member State Centralised Procedure Clinical Study Report Decentralised Procedure

PI

Product Information

CP

PIP

Paediatric Investigation Plan

CSR DCP

PL

Patient Leaflet

PBRER PRAC PSMF PSUR PUMA

Periodic Benefit-Risk Evaluation Report

DHPC

Direct Healthcare Professional Communication

Pharmacovigilance Risk Assessment Committee

DLP

Data lock point

Pharmacovigilance System Master File

EC

European Commission

Periodic Safety Update Reports

EdTs EMA EURD

Educational Tools

Paediatric-use Marketing Authorisation

European Medicines Agency

RDP

Regulatory Data Protection Risk Minimisation Measures Risk Management Plan Reference Member State Reference Safety Information Scientific Advisory Group

EU Reference Dates

RMMs

HTA

Health Technology Assessment

RMP RMS RSI SAG

MA

Marketing Authorisation

MAH MRP

Marketing Authorisation Holder Mutual Recognition Procedure

MS

Member State

SmPC

Summary of Product Characteristics

NCA

National Competent Authority

USR

Urgent Safety Restrictions

OE

Oral explanation

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