543 results
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PRAC recommendations on safety signals (updated)
Last updated: 06/02/2023 -
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Quality: non-immunologicals (updated)
Last updated: 03/02/2023 -
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Plasma master file certificates (updated)
Last updated: 02/02/2023 -
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Variations not requiring assessment (veterinary medicines) (updated)
Last updated: 01/02/2023 -
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PRIME: priority medicines (updated)
Last updated: 01/02/2023 -
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Mutual recognition agreements (MRA) (updated)
Last updated: 01/02/2023 -
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Certification procedures for micro-, small- and medium-sized enterprises (SMEs) (updated)
Last updated: 01/02/2023 -
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International collaboration on GMP inspections (updated)
Last updated: 01/02/2023 -
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Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023 (updated)
Online, 10:00 - 13:00 Amsterdam time (CET), 20/01/2023, Last updated: 31/01/2023 -
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Biosimilar medicines: Overview (updated)
Last updated: 27/01/2023 -
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Safety and residues: pharmaceuticals (updated)
Last updated: 27/01/2023 -
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Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) (updated)
Last updated: 26/01/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 25/01/2023 -
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How to pay (updated)
Last updated: 20/01/2023 -
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Changing the name or address of a sponsor (updated)
Last updated: 20/01/2023 -
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Changing the (invented) name of a veterinary medicine (updated)
Last updated: 12/01/2023 -
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Ninth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicine (updated)
Online, 13:00 - 17:30 Amsterdam time (CET), 24/11/2022, Last updated: 11/01/2023 -
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Exemptions to labelling and package-leaflet obligations (updated)
Last updated: 11/01/2023 -
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Extensions of marketing authorisations: questions and answers
Last updated: 06/01/2023 -
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Pre-authorisation guidance
Last updated: 06/01/2023 -
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Notifying a change of marketing status
Last updated: 06/01/2023 -
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Good manufacturing practice
Last updated: 05/01/2023 -
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Post-authorisation measures: questions and answers
Last updated: 05/01/2023 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers
Last updated: 05/01/2023 -
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Type-II variations: questions and answers
Last updated: 05/01/2023