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Formal Comments

formal-comments

We issue formal comments as part of our role as advisor on all matters relating to the procesing of personal data.

Similar to our Opinions, our Formal Comments are issued in response to a request from the European Commission under Article 42(1) of Regulation (EU) 2018/1725 and address the data protection implications of a legislative proposal or a draft implementing or delegated act. Our Formal comments are usually shorter and more technical, or only address certain aspects of a proposal.

 

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14
May
2024

EDPS Formal comments on the draft Commission Implementing Decision of the functionalities of the VIS Central System repealing Commission Decision 2009/876/EC and Commission Implementing Decision C (2015) 5561

EDPS Formal comments on the draft Commission Implementing Decision laying down measures necessary for the technical implementation of the functionalities of the VIS Central System, in particular for entering the data and linking applications, for accessing the data, for rectification, erasure and advance erasure of data, for keeping and accessing the logs of data processing operations, for the consultation mechanism and its procedures, and for accessing the data for the purposes of reporting and statistics in the Visa Information System, repealing Commission Decision 2009/876/EC and Commission Implementing Decision C(2015) 5561 

Available languages: English
Topics
4
Apr
2024

EDPS Formal comments on Draft Implementing Regulation for Health Technology Assessment under Regulation (EU) 2021/2282

EDPS Formal comments on the draft Commission Implementing Regulation laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments

Available languages: English
Topics
26
Mar
2024

EDPS Formal comments on draft Commission rules for applying EU Regulation 2023/988, detailing how consumers can report risky products to the Commission and how this information is transmitted to national authorities

EDPS Formal comments on the draft Commission Implementing Regulation laying down the rules for the application of Regulation(EU) 2023/988 of the European Parliament and of the Council as regards the modalities for consumers and other interested parties to inform the Commission of products that might present a risk to the health and safety of consumers and for the transmission of such information to the national authorities concerned

Available languages: English
8
Mar
2024

EDPS Formal comments on the draft Commission Implementing Regulation laying down the technical specifications, measures and other requirements for the implementation of the decentralised IT system referred in Regulation (EU) 2020/1784 of EP and Council

EDPS Formal comments on the draft Commission Implementing Regulation laying down the technical specifications, measures and other requirements for the implementation of the decentralised IT system referred to in Regulation (EU) 2020/1784 of the European Parliament and of the Council

Available languages: English
Topics
4
Mar
2024

EDPS Formal comments on the draft Implementing Regulation laying down rules for the application of Directive 2009/103/EC of the European Parliament and of the Council as regards the template for the claims-history statement.

EDPS Formal comments on the draft Implementing Regulation laying down rules for the application of Directive 2009/103/EC of the European Parliament and of the Council as regards the template for the claims-history statement

Available languages: English