Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
Market Exclusivity
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.
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.
Mock-up Vaccine
A vaccine that contains a strain of flu virus which could cause a pandemic. The mock-up procedure allows an accelerated development of a vaccine in advance of a pandemic.
Mutual Recognition
A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.