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  1. www.credo.ai/eu-ai-act

    AnzeigeEU AI Act Explained - EU AI Act Impact Assessment

    Identify and mitigate risk across all of your AI systems with an impact assessment. Learn more about the EU AI Act, when it comes into force, and what it means for you.

    Avoid Fines & Penalties · Get Compliant Today · Audit High-Risk Systems

    How Credo AI can support you in preparing for the EU AI Act.

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  1. www.ema.europa.eu › en › human-regulatory-overviewPre-authorisation guidance | European Medicines Agency

    12. März 2023 · An applicant should demonstrate that it is duly established in the EEA. A proof of establishment from the applicant company is required by the Agency in order for an application to be validated (e.g. in France, an extrait du registre du commerce et des sociétés, in Belgium an extract from Crossroad Database of Belgian Enterprises ...

  2. www.ema.europa.eu › en › human-regulatory-overviewTransfer of marketing authorisation: questions and answers

    4) A proof of establishment of the Transferee within the European Economic Area (EEA), issued in accordance with national provisions (e.g. Chamber of Commerce). This document should be no older than 6 months.

  3. www.ema.europa.eu › en › about-usApplying for SME status | European Medicines Agency

    Supporting documents such as annual accounts, annual reports or evidence of proof of establishment can be submitted in any official EU language. After review, the Agency issues an SME number and notifies the applicant that SME status has been assigned.

  4. iris.ema.europa.eu › forums › whats-newQ&A on Scientific Advice submissions in IRIS · IRIS

    18. Sept. 2020 · However, proof of establishment in the EEA is still required as an attached document for Orphan Designation Applications. your understanding is correct. as a self-declaration that the person is still acting on behalf of the organization, for that specific submission.

  5. www.hma.eu › human-medicines › cmdhHeads of Medicines Agencies: Application for MA

    Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers (May 2024) [ Track version]

  6. www.propharmagroup.com › thought-leadership › orphan-drugOrphan Drug Designations in the U.S. and EU - ProPharma Group

    8. Juli 2022 · To qualify for orphan designation in the EU, a medicine must meet the following criteria: The product must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating.

  7. www.hma.eu › fileadmin › dateienHeads of Medicines Agencies: About HMA

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