Eurordis - Rare Disease Europe

Risk Management Plans (RMP) include information on:

Traceability is important in the manufacturing of medicines for which of the following reasons?

Registries are important even after a medicinal product is on the market, for which of the following reasons?

What is the use of the Summary of Product Characteristics (SmPC)?

A centralised procedure for evaluating medicinal productst is compulsory in Europe for which of the following medicines:

When a medicine has been approved in one EU member state and seeks to apply for registration in another, the original registering country can confirm its registration and the other countries can accept this confirmation without the need to start the registration procedures from the beginning. This process is known as what?

What are Bioequivalent studies used for?

When does Accelerated Assessment apply?

What may be granted in a case where the immediate availability of a medicine outweighs the risk of less comprehensive data than normally required before authorisation.

When do ‘exceptional circumstances’ for marketing authorisations apply?