Frequently asked questions

Do you need more information on a topic? This section contains frequently asked questions and their answers.

Clinical drug trials

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?

Generic medicines

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?

Invoicing

How should I provide my invoicing information? Can I provide multiple invoicing addresses?

Marketing authorisations

This page contains answers for questions on marketing authorisation, fees, composition, product information, package sizes, therapeutic indication and variation applications related to marketing authorisations.

Narcotics control

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.

Pharmacovigilance

The European Medicine Agency's new EudraVigilance database has been fully functional since 22 November 2017. Fimea's questions and answers.