1264 results
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Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines (updated)
Virtual meeting, 03/12/2020, Last updated: 18/01/2021 -
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Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation (updated)
Last updated: 13/01/2021 -
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Generic and hybrid applications (updated)
Last updated: 13/01/2021 -
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Pre-authorisation guidance (updated)
Last updated: 13/01/2021 -
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Risk management plan (RMP): questions and answers (updated)
Last updated: 13/01/2021 -
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Extensions of marketing authorisations: questions and answers (updated)
Last updated: 13/01/2021 -
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Post-authorisation efficacy studies: questions and answers (updated)
Last updated: 13/01/2021 -
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Type-II variations: questions and answers (updated)
Last updated: 13/01/2021 -
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EudraVigilance access policy for medicines for veterinary use (updated)
Last updated: 12/01/2021 -
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Pharmacovigilance fees: questions and answers (updated)
Last updated: 06/01/2021 -
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Product-information templates - Human (updated)
Last updated: 31/12/2020 -
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Product information: Reference documents and guidelines (updated)
Last updated: 31/12/2020 -
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Product-information templates - Veterinary (updated)
Last updated: 31/12/2020 -
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VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use
Last updated: 22/12/2020 -
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Conditional marketing authorisation
Last updated: 21/12/2020 -
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Clinical Trial Regulation
Last updated: 18/12/2020 -
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Procedural timetables
Last updated: 18/12/2020 -
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COVID-19 guidance: assessment and marketing authorisation
Last updated: 18/12/2020 -
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COVID-19 guidance: post-authorisation
Last updated: 18/12/2020 -
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COVID-19 guidance: research and development
Last updated: 18/12/2020 -
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Advanced therapy classification
Last updated: 17/12/2020 -
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Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
Last updated: 17/12/2020 -
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EudraVigilance training and support
Last updated: 17/12/2020 -
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Extended EudraVigilance medicinal product dictionary (XEVMPD) training
Last updated: 17/12/2020 -
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Levothyroxine product-specific bioequivalence guidance
Last updated: 16/12/2020