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How the European Medicines Agency (EMA) deals with requests for public access to documents concerning a large number of documents
Prípad 2243/2022/SF - Otvorené dňa Utorok | 14 februára 2023 - Rozhodnutie z dňa Streda | 13 decembra 2023 - Dotknutý orgán Európska agentúra pre lieky ( Zistený nesprávny úradný postup ) - Krajina Holandsko
Sťažnosť podaná
13/12/2022Analýza sťažnosti
13/12/2022Prebieha vyšetrovanie
11/01/2023Výsledok vyšetrovania
13/12/2023
The complainant asked the European Medicines Agency (EMA) to grant public access to documents concerning a vaccine for infectious bovine rhinotracheitis. In the course of EMA's processing of the request, it emerged that EMA was applying a queuing system for processing the request, that is processing the different documents identified under the request at different stages. EMA also limited the number of documents the complainant could request to two documents per request.
The Ombudsman opened an inquiry and asked EMA about the practices for dealing with public access requests that were raised by the complainant.
The Ombudsman considered that EMA’s current practice of automatically placing certain categories of requests for public access in a chronological queue cannot be good administration and is also not in line with the EU legislation on public access to documents, in particular its requirement that access requests shall be handled “promptly”. The Ombudsman further considered arbitrary EMA’s practice of limiting automatically and unilaterally the number of documents that can be covered by public access requests or the number of requests that individuals can submit at any given time. The Ombudsman found that this constitutes maladministration.
As EMA is already taking proactive steps to phase out the practice of the chronological queue, the Ombudsman refrained from making a recommendation in this case and instead asked EMA to report back. The Ombudsman will then determine if she needs to take further action.
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