Who has the responsibility for signing the declaration statement in the Marketing Authorisation Application in the EU?

The responsibility for signing the declaration statement in a Marketing Authorisation Application (MAA) in the EU falls to an expert with the necessary technical or professional qualifications. This requirement ensures that the individual signing the declaration possesses the appropriate knowledge and understanding of the data contained in the application and its compliance with regulatory standards.

This role is crucial because the declaration statement is a formal commitment regarding the quality, safety, and efficacy of the drug being submitted for approval. It is important that the person signing the document has the requisite expertise to affirm that the information provided is accurate and meets the necessary regulatory requirements.

While other roles in the organization, like the CEO or regulatory affairs manager, may have significant involvement in the application process, the regulatory framework explicitly necessitates that the declaration be signed by someone who has the relevant scientific or technical qualifications, reinforcing the importance of accountability and expert oversight in the marketing authorization process.