Frequently asked questions
Do you need more information on a topic? This section contains frequently asked questions and their answers.
What is an investigational medicinal product? Must all of them be manufactured in a pharmaceutical facility? How should adverse effects be reported and how should the EudraCT form be filled in and submitted?
What are generic medicines? What are the benefits to patients and society? Why does the information provided in the package leaflet vary between generic products?
How should I provide my invoicing information? Can I provide multiple invoicing addresses?
This page contains answers for questions on marketing authorisation, fees, composition, product information, package sizes, therapeutic indication and variation applications related to marketing authorisations.
This page contains the most common answers to questions on the licenses to import, export and handle narcotic drugs. Moreover, the section contains information on applying for these licenses and the information required in the applications.
The European Medicine Agency's new EudraVigilance database has been fully functional since 22 November 2017. Fimea's questions and answers.