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
  • EU rules governing access to clinical trials data
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

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)