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• Accelerated assessment

• Access to documents

• Active substance

• Active substance master file

• Adjuvant

• Advanced therapy medicinal product

• Adverse drug reaction

• Adverse event

• Ancillary human blood derivative

• Ancillary medicinal substance

• Annual re-assessment

• Article 58 application

• ATC code

• Bioavailability

• Bioequivalence

• Biomarker

• Biomarker qualification

• Biosimilar medicine

• Biotechnology

• CAT

• Centralised procedure

• Centrally authorised product

• CHMP

• Class waiver

• Clinical trial

• Clock stop

• CMDh

• CMDv

• Co-rapporteur

• Commercially confidential information

• Committee for Advanced Therapies

• Committee for Medicinal Products for Human Use

• Committee for Orphan Medicinal Products

• Committee for Proprietary Medicinal Products

• Committee for Veterinary Medicinal Products

• Committee on Herbal Medicinal Products

• Common technical document

• COMP

• Compassionate use

• Competent authority

• Concept paper

• Concerned Member State

• Conditional marketing authorisation

• Coordination Group for Mutual Recognition and Decentralised Procedures - Human

• Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products

• Counterfeit medicine

• CVMP

• Data exclusivity

• Decentralised procedure

• Declaration of interests

• Deferral (paediatric)

• Direct healthcare-professional communication

• Electronic common technical document

• Environmental risk assessment

• EudraCT

• EudraNet

• EudraPharm

• EudraVigilance

• EURD list

• European Commission decision

• European medicines regulatory network

• European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

• European Network of Paediatric Research at the European Medicines Agency

• European Pharmacopoeia

• European public assessment report

• European Review System

• European Union Clinical Trials Register

• European Union herbal monograph

• Exceptional circumstances

• Excipient

• Falsified medicine

• Gene-therapy medicine

• Generic medicine

• Good agricultural and collection practice

• Good clinical practice

• Good distribution practice

• Good laboratory practice

• Good manufacturing practice

• Good pharmacovigilance practices

• Grouping

• Guideline

• Heads of Medicines Agencies

• Health technology assessment body

• Herbal medicinal product

• Herbal preparations

• Herbal substances

• HMPC

• Hybrid medicine

• ICH

• Indication

• Individual case safety report

• Informed consent application

• Innovative medicine

• International birth date

• International non-proprietary name

• Invented name

• Investigational medicinal product

• Labelling

• List of outstanding issues

• List of questions

• Market exclusivity

• Market protection

• Marketing authorisation

• Marketing authorisation application

• Marketing authorisation holder

• Master data

• Maximum residue limit

• Medicinal product

• Minor use/minor species

• Mock-up

• Mock-up vaccine

• Modelling and simulation

• Mutual recognition

• Mutual recognition agreement

• Nanotechnology

• National competent authority

• Nationally authorised product

• Note for guidance

• Notified body

• Off-label use

• Official Journal of the European Union

• Official medicines control laboratory

• Oral explanation

• Orphan designation

• Package leaflet

• Paediatric Committee

• Paediatric investigation plan

• Paediatric-use marketing authorisation

• Parallel distribution

• Patent

• PDCO

• Periodic safety update report

• Personalised medicine

• Pharmaceutical form

• Pharmacogenomics

• Pharmacovigilance

• Pharmacovigilance Risk Assessment Committee

• Phase-I study

• Phase-II study

• Phase-III study

• Phase-IV study

• Plasma master file

• PRAC

• Product information

• Product-specific waiver

• Protocol assistance

• Rapporteur

• Re-examination

• Reference Member State

• Referral

• Reflection paper

• Regulatory authority

• Renewal

• Request for supplementary information

• Risk management plan

• Risk management system

• Risk minimisation activity

• Route of administration

• Safety signal

• Scientific advice

• Scientific advisory group

• Serious adverse reaction

• Somatic cell based medicine

• Specific obligations

• Specimen

• Subgroup analysis

• Summary of opinion

• Summary of product characteristics

• Sunset clause

• Supplementary protection certificate

• Third country

• Tissue-engineered product

• Transfer of marketing authorisation

• Trial protocol

• Type IA variation

• Type IB variation

• Type II variation

• Urgent safety restriction

• Variation

• Well-established use

• Withdrawal period

• Working party

• Worksharing