209 results
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019 -
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Orphan designation: Lenvatinib for: Treatment of hepatocellular carcinoma
Date of designation: 19/03/2015, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of papillary thyroid cancer
Date of designation: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of follicular thyroid cancer
Date of designation: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Maximum residue limit opinions (updated)
Last updated: 01/07/2022 -
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Quality of medicines questions and answers: Part 2 (updated)
Last updated: 01/07/2022 -
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PRIME: priority medicines (updated)
Last updated: 29/06/2022 -
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Big data (updated)
Last updated: 13/06/2022 -
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Innovation in medicines (updated)
Last updated: 13/06/2022 -
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Submitting annual reports on medicine development (updated)
Last updated: 09/06/2022 -
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Changing the name or address of a sponsor (updated)
Last updated: 09/06/2022 -
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Orphans: Regulatory and procedural guidance and forms (updated)
Last updated: 09/06/2022 -
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Transferring an orphan designation (updated)
Last updated: 09/06/2022 -
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Plasma master file certificates (updated)
Last updated: 08/06/2022 -
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COVID-19 treatments: research and development
Last updated: 24/05/2022 -
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COVID-19 vaccines: research and development
Last updated: 24/05/2022 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development
Last updated: 06/05/2022 -
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Good clinical practice (GCP) inspection procedures
Last updated: 05/05/2022 -
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ICH Q3D Elemental impurities
Last updated: 03/05/2022 -
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Submission deadlines for orphan designations
Last updated: 25/04/2022 -
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GMP/GDP Inspectors Working Group
Last updated: 20/04/2022 -
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Parallel joint scientific consultation with regulators and health technology assessment bodies
Last updated: 12/04/2022 -
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ICH: quality
Last updated: 01/04/2022 -
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Union Product Database: follow up webinar for marketing authorisation holders
Online, 15:00 - 16:30 Amsterdam time (CET), 25/01/2022, Last updated: 22/03/2022 -
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Seventh industry stakeholder platform on research and development support
Online, 23/11/2021, Last updated: 17/03/2022