Glossary


  • Active ingredient

  • ADR – Adverse drug reaction

  • Advisory Committees

  • AI – Adverse incident

  • Animal remedy

  • Annual safety report

  • Authorisation


  • BEMA – Benchmarking of European Medicines Agencies

  • Blood establishment

  • Borderline products


  • CA – Competent Authority

  • CE mark

  • Centralised procedure

  • CFS – Certificate of Free Sale

  • CHMP – Committee on Medicinal Products for Human Use

  • Clinical investigation

  • CMD – Coordination Group for Mutual Recognition and Decentralised procedures (human)

  • CMS – Concerned Member State / RMS – Reference Member State

  • Controlled drug

  • Co-rapporteur

  • Cosmetic products

  • CVMP – Committee for Medicinal Products for Veterinary Use


  • DAFM

  • DCP – Decentralised procedure

  • DoH

  • Dossier

  • DPR – Dual pack registration


  • EDQM – European Directorate for the Quality of Medicines

  • EEA – European Economic Area

  • EMA – European Medicines Agency

  • Epidemiological studies

  • EUDAMED

  • EudraCT

  • EudraPharm

  • EudraVigilance

  • Exempt medicinal product


  • GCP – Good clinical practice

  • GDP – Good distribution practice

  • Generic

  • GLP – Good laboratory practice

  • GMP – Good manufacturing practice


  • IMF – Irish Medicines Formulary

  • Implantable medical device

  • IVD – In-vitro diagnostic




  • Licence


  • MA – Marketing authorisation

  • MAH – Marketing authorisation holder

  • MDEG - Medical Devices Expert Group

  • MEDDEV

  • Medical device

  • Medicinal product

  • Member State

  • MIMS (Ireland) – Monthly Index of Medical Speciali

  • MR/MRP – Mutual Recognition Procedure


  • National Competent Authority reports

  • National procedure

  • Notified Body


  • Off-label use

  • OMCL – Official Medicines Control Laboratories

  • Orphan medicine

  • OTC – Over the counter


  • PA – Product Authorisation

  • Parallel importation

  • Patients and consumers

  • Periodic safety update reports

  • Pharmacovigilance

  • PIL – Patient information leaflet

  • POM – Prescription Only Medicine

  • Precursor chemical

  • Product recall


  • Rapporteur(ships)

  • RIO extranet

  • RMS – Reference Member State

  • RSS – Really simple syndication


  • SAE/R – Serious adverse event/reaction



  • Variation

  • Veterinary medicinal product

  • VPA –Veterinary product authorisation