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Type-IA variations: questions and answers
Last updated: 22/01/2020 -
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Good manufacturing practice
Last updated: 21/11/2022 -
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Q&A: Type II variations vs Extension applications
Last updated: 18/06/2019considered to fundamentally alter the terms of this authorisation …
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Other post-authorisation activities: questions and answers
Last updated: 28/09/2018Authorities' representatives and alternates. This will apply to all types …
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Veterinary pre-submission Q&A: 1-20
Last updated: 22/03/2021medicinal product provides a new alternative in treating, preventing or …
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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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Good manufacturing practice (updated)
Last updated: 05/01/2023 -
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Handling competing interests (updated)
Last updated: 04/01/2023Requirement for members and alternates of EMA’s The committee … to members also applies to alternates. 3 Regulation (EU) 2017/745 … including, where relevant, alternates) and experts involved in …
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Transferring a veterinary marketing authorisation
Last updated: 20/12/2019action. medicinal product . Alternatively, in case the product name …
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Q&A: Extension applications
Last updated: 22/09/2020Authorities (NCA) representatives, alternates and scientific experts. Extension …
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Renewal and annual re-assessment of marketing authorisation
Last updated: 20/06/2022unchanged and applicable. Alternatively, if applicable, the MAH can …
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Questions and answers: Article 35 veterinary referral procedures
Last updated: 20/12/2017from amongst the members or alternates. If the procedure was triggered …
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Central register of data processing records
Last updated: 25/01/2021 -
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Scientific publications
Last updated: 18/11/2022Prescribing Patterns of Codeine and Alternative Medicines in Children in …
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Worksharing of variations (veterinary medicines)
Last updated: 20/01/2022Authorities ’ representatives, alternates and scientific experts. The …
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Questions and answers: Article 13 referral procedures
Last updated: 06/07/2016 -
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Eligible patients and consumers organisations (updated)
Last updated: 25/01/2023European Network for Research in Alternating Hemiplegia …
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How EMA evaluates medicines for human use
Last updated: 01/07/2019composed of one member and an alternate from each EU Member State …
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Q&A: Worksharing of variations
Last updated: 20/12/2019Authorities ’ representatives, alternates and scientific experts. The …
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Post-authorisation measures (recommendations, conditions and specific obligations)
Last updated: 20/12/2019 -
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Classifications as minor-use-minor-species and limited-market according to former EMA policy
Last updated: 06/12/2021policy where there was no alternative treatment authorised for …
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Quality of medicines questions and answers: Part 1
Last updated: 05/02/2020action. medicinal product with alternative compositions …
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COVID-19: latest updates
Last updated: 31/10/2022 -
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Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline (updated)
Last updated: 27/01/2023 -
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CVMP: Agendas, minutes and reports (updated)
Last updated: 26/01/2023