544 results
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CHMP opinions on consultation procedures (updated)
Last updated: 22/11/2023 -
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Parallel distribution: Regulatory and procedural guidance (updated)
Last updated: 21/11/2023 -
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PRAC recommendations on safety signals (updated)
Last updated: 20/11/2023 -
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Maximum residue limit opinions (updated)
Last updated: 14/11/2023 -
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Pre-authorisation guidance (updated)
Last updated: 13/11/2023 -
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Type-IA variations: questions and answers (updated)
Last updated: 13/11/2023 -
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Worksharing: questions and answers (updated)
Last updated: 13/11/2023 -
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Grouping of variations: questions and answers (updated)
Last updated: 13/11/2023 -
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Biosimilar medicines: Overview (updated)
Last updated: 13/11/2023 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers (updated)
Last updated: 09/11/2023 -
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Marketing authorisation (veterinary medicines) (updated)
Last updated: 08/11/2023 -
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Immunologicals guidelines (updated)
Last updated: 08/11/2023 -
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Efficacy guidelines (updated)
Last updated: 08/11/2023 -
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Quality guidelines (updated)
Last updated: 08/11/2023 -
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Scientific guidelines for veterinary medicines (updated)
Last updated: 08/11/2023 -
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Fees payable to the European Medicines Agency (updated)
Last updated: 08/11/2023 -
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Compliance: marketing authorisation (updated)
Last updated: 07/11/2023 -
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PRIME: priority medicines (updated)
Last updated: 03/11/2023 -
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List of medicines under additional monitoring
Last updated: 25/10/2023 -
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Variations requiring assessment (veterinary medicines)
Last updated: 20/10/2023 -
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EU Innovation Network (EU-IN)
Last updated: 19/10/2023 -
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Quality: non-immunologicals
Last updated: 18/10/2023 -
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Quality: specific types of products
Last updated: 18/10/2023 -
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COVID-19 guidance: research and development
Last updated: 16/10/2023 -
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Procedures for monograph and list entry establishment
Last updated: 16/10/2023