Glossary

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This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents.

Click on a letter below to see terms beginning with that letter.

Disclaimer: EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.

Glossary

package leaflet

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

Paediatric Committee

The committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals. Abbreviated as PDCO.

For more information, see Paediatric Committee (PDCO).

paediatric investigation plan

A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed paediatric investigation plan, unless the medicine is exempt because of a deferral or waiver

For more information, see Paediatric investigation plans.

paediatric-use marketing authorisation

A type of marketing authorisation covering the indication(s) and appropriate formulation(s) for the paediatric population, which was introduced by the Paediatric Regulation. Applicants can request paediatric-use marketing authorisations for medicines that are already authorised, are no longer covered by a supplementary protection certificate or a patent that qualifies as such and are developed exclusively for use in children.

Abbreviated as PUMA.

For more information, see Paediatric-use marketing authorisations.

parallel distribution

The distribution of a medicine from one Member State to another by a pharmaceutical company independently of the marketing authorisation holder.

For more information, see Parallel distribution.

patent

An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined period.

PDCO

Paediatric Committee: the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.

For more information, see Paediatric Committee (PDCO).

periodic safety update report

A report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation. Abbreviated as PSUR.

For more information, see Periodic safety update reports: questions and answers.

personalised medicine

A medicine that is targeted to individual patients, based on their genetic characteristics.

For more information, see Pharmacogenomics and personalised medicine.

pharmaceutical form

The way a medicine is presented, e.g. tablet, capsule, solution for injection, cream, etc.

pharmacogenomics

The study of how the variability of the expression of genes between people leads to differences in susceptibility to disease and responses to medicines.

For  more information, see Pharmacogenomics and personalised medicine.

pharmacovigilance

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

For more information, see Safety monitoring of medicines.

Pharmacovigilance Risk Assessment Committee

The committee that is responsible for assessing all aspects of the risk management of medicines for human use. Abbreviated as PRAC.

For more information, see Pharmacovigilance Risk Assessment Committee (PRAC).

phase-I study

A type of clinical study where a new medicine is given to humans for the first time, usually in healthy volunteers. It looks at the way the medicine is dealt with by the body, its main effects and main side effects.

phase-II study

A type of clinical study conducted after phase I studies to evaluate a medicine’s effects in a particular condition and to determine its common short-term side effects.

phase-III study

A type of clinical study usually conducted in a large group of patients to gather information about a medicine's efficacy and safety, to allow its benefits and risks to be evaluated.

phase-IV study

A type of clinical study that takes place after the authorisation of a medicine.

plasma master file

Documentation providing detailed information on the characteristics of the human plasma used in a medicine or a medical device.

For more information, see plasma master files.

PRAC

Pharmacovigilance Risk Assessment Committee: the committee that is responsible for assessing all aspects of the risk management of medicines for human use.

For more information, see Pharmacovigilance Risk Assessment Committee (PRAC).

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.

For more information, see Product information requirements.

product-specific waiver

An exemption from the obligation to acquire data, through a paediatric investigation plan, in some or all subsets of the paediatric population for a given condition, route of administration and pharmaceutical form of a specified medicine. Product-specific waivers are adopted by the Paediatric Committee (PDCO).

For more information, see Paediatric investigation plans, waivers and modifications.

protocol assistance

A type of scientific advice for companies developing orphan medicines.

For more information, see Scientific advice and protocol assistance.