Access to documents and information on medicinal products in the EU
Produced in partnership with Vincenzo Salvatore of Of counsel at Bonelli Erede law firm, Milan. Avvocato. Former head of the Legal Service at the European Medicines Agency
Access to documents and information on medicinal products in the EU

The following Life Sciences guidance note Produced in partnership with Vincenzo Salvatore of Of counsel at Bonelli Erede law firm, Milan. Avvocato. Former head of the Legal Service at the European Medicines Agency provides comprehensive and up to date legal information covering:

  • Access to documents and information on medicinal products in the EU
  • The transparency principle
  • Access to documents—EU legislative framework and EMA policies
  • Exceptions to the right of access to documents
  • Interaction between EMA and the document’s originator
  • Procedure to request a document to the EMA
  • Rules governing requests for information
  • Denied access to the requested document
  • Proactive disclosure of documents and information
  • New EU rules governing access to clinical trials data
  • more

In recent years, we have witnessed a constantly growing interest from all stakeholders (the general public, patients associations, physicians, pharmaceutical industry and academia alike) to get access to information concerning medicinal products. Under this pressure, both legislators and medicines regulatory authorities have moved towards a more generous approach giving access to a larger set of documents and information related to the quality, safety and efficacy of medicinal products than ever before. In the EU, the European Medicines Agency (EMA) is the regulatory body responsible for the protection and promotion of human and animal health. Some of the EMA’s key responsibilities include the scientific evaluation of applications for marketing authorisation (MA) of medicines through the centralised procedure and the co-ordination of the EU pharmacovigilance system for the monitoring of the safety of medicinal products. The EMA therefore holds a large volume of scientific and clinical data on medicines. There are several channels through which documents and information on medicinal products can be accessed. These can broadly be summarised as the following:

  1. via a request for access to certain documents to the regulatory authority that hold those documents

  2. following a release pursuant to legal obligations, eg the rules governing clinical trials which mandate that certain information be made publicly available via the clinical trial database or the rules on authorisation of medicines which