Transparency: questions and answers

This page lists questions that marketing-authorisation holders (MAHs) may have on transparency. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

Since the establishment of EMA, transparency has been an important feature of the Agency's operation. This resulted in the introduction of the European Public Assessment Reports (EPARs) in line with the requirements of the Community legislation. European Union (EU) law sets the minimum level of transparency that the Agency must apply. However, in many areas, the Agency has decided to go beyond what law requires, so that it can provide as much information to the public as possible. In all cases, it takes care to balance this with the protection of commercially confidential information and personal data.

An overview of the EMA transparency measures are presented on the Transparency page on EMA's website.

The Agency has also published a PDF iconguide to information on human medicines evaluated by EMA which describes the different types of information the Agency currently publishes for both centrally and non-centrally authorised medicines, as well as publication times and location on EMA's website. The guide aims to help stakeholders know what kind of information to expect on medicines undergoing evaluations and other regulatory procedures.

In addition, the public has the right to request information and documents from the Agency in accordance with its rules on access to documents.

How useful was this page?

Add your rating