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.
The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be placed on the market.
For more information, see marketing authorisation and market exclusivity.
The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity. During this period, applications for generics can be accepted and authorised, but the generic medicines cannot be placed on the market.
The approval to market a medicine in one, several or all European Union Member States.
An application made to a European regulatory authority for approval to market a medicine within the European Union.
The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States.
Any non-transactional information considered to play a key role in the core operation of a business and re-used for multiple purposes.
For more information, see Substance, product, organisation and referential (SPOR) master data.
The maximum concentration of a medicine residue that is considered acceptable in food produced from an animal that has been treated with that medicine.
For more information, see maximum residue limits.
A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action.
A type of veterinary medicine that is to be used in small numbers of animals or in animals of low individual economic value, such as honey bees.
For more information, see Minor uses / minor species and limited markets.
A copy of the flat artwork design for a medicine's inner and outer packaging, in full colour, that can be assembled into a three-dimensional replica.
For more information, see mock-ups and specimens.
A vaccine that contains a strain of flu virus which that could cause a pandemic. The mock-up procedure allows a vaccine to be developed in advance of a pandemic.
For more information, see vaccines for pandemic influenza.
Techniques that use mathematical models to understand and predict the outcomes of interventions.
For more information, see methodologies and statistics.
A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.
For more information, see volume 2A: Procedures for marketing authorisation: Chapter 2: Mutual recognition.
An agreement between two regulatory agencies to recognise each other's regulatory assessments, inspections or reviews.