MHRA Signal Summaries – Glossary

Adverse drug reaction (ADR) – an unintended and adverse response to a medicine

British National Formulary (BNF) – The BNF provides prescribers, pharmacists and other healthcare professionals with up-to-date information about the use of medicines, including information about prescribing, dispensing and administration.

Centrally authorised product – A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union

Contraindication – A contraindication is a situation in which it is inadvisable to use a particular medicine in certain circumstances.

Clinical trial – A study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.

Efficacy – The measurement of a medicine’s desired effect under ideal conditions, such as in a clinical trial.

EudraVigilance – A centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA).

Indication – A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.

Marketing Authorisation Holder – The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States

Mutual recognition – A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.

Nationally authorised product – a medicine authorised in a Member State in accordance with its national authorisation procedure.

Off-label use – Use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration.

Patient Information Leaflet – The leaflet in every pack of medicine that contains information on the medicine for end-users, such as patients and animal owners.

Periodic safety update report (PSUR) - A report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation.

Pharmacovigilance – Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Pharmacovigilance Expert Advisory Group (PEAG) – The Pharmacovigilance Expert Advisory Group (PEAG) advise the Commission on Human Medicines (CHM) on matters relating to human medicines including herbal products. 

Pharmacovigilance Risk Assessment Committee  (PRAC) – The committee that is responsible for assessing all aspects of the risk management of medicines for human use.

Product information – Documents providing officially approved information for healthcare professionals and patients on a medicine. The product information includes the summary of product characteristics, package leaflet and labelling.

Rapporteur – One of the two members of a committee or working party who leads the evaluation of an application.

Reference Member State – The European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure.

Regulatory authority – A body that carries out regulatory activities relating to medicines, including the processing of marketing authorisations, the monitoring of side effects, inspections, quality testing and monitoring the use of medicines.

Risk management plan (RMP) – A detailed description of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines.

Route of administration – The way in which a medicine is given, e.g. orally (by mouth), intravenously (into a vein), subcutaneously (under the skin), etc.

Spontaneous reports – Suspected Adverse Drug reaction (ADR) reports sent into the Yellow Card Scheme are called spontaneous reports

Summary of medicinal Product Characteristics – A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC.

Validated signal – Information on a new or known adverse event that is potentially caused by a medicine and that has been confirmed as warranting further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature.

Variation – A change to the terms of a marketing authorisation.