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Variations not requiring assessment (veterinary medicines) (updated)
Last updated: 01/02/2023presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Q&A: Type II variations vs Extension applications
Last updated: 18/06/2019presented, e.g. tablet, capsule, solution for injection, cream, etc … presented, e.g. tablet, capsule, solution for injection, cream, etc … replacement of a presentation for a solution for injection with a different …
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Reflection paper on the application of Regulation (EU) 2019/6 for certain categories of variations
Last updated: 24/11/2022presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Quality of medicines questions and answers: Part 2
Last updated: 01/07/2022presented, e.g. tablet, capsule, solution for injection, cream, etc … presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Type-IB variations: questions and answers
Last updated: 22/01/2020 -
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Type-IA variations: questions and answers
Last updated: 22/01/2020presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Q&A: Extension applications
Last updated: 22/09/2020presented, e.g. tablet, capsule, solution for injection, cream, etc … presented, e.g. tablet, capsule, solution for injection, cream, etc … presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline
Last updated: 26/07/2021presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Availability of medicines
Last updated: 26/09/2022strategic and structural solutions to tackle disruptions in the … are multifactorial, the solutions require actions at different …
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Fees payable to the European Medicines Agency
Last updated: 01/04/2022presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Certification of medicinal products (updated)
Last updated: 16/01/2023presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Coordination of pharmacovigilance inspections (updated)
Last updated: 12/01/2023software-as-a-service (SaaS or cloud solution). Different requirements will …
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Big data
Last updated: 28/10/2022Force meeting: identifying solutions for big data challenges (04/05/2018 …
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Quality of medicines questions and answers: Part 1
Last updated: 05/02/2020c) Are APIs in solutions (e.g. Benzalkonium chloride solution) considered as an API mix … ASMFs or CEP applications for solutions of APIs acceptable …
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Transparency (veterinary medicines)
Last updated: 10/01/2022presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Variations requiring assessment (veterinary medicines)
Last updated: 20/01/2022presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Scientific advice and protocol assistance
Last updated: 14/10/2022identifies questions and possible solutions. EMA then gives advice on …
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Veterinary pre-submission Q&A: 1-20
Last updated: 22/03/2021 -
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European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
Last updated: 09/01/2023presented, e.g. tablet, capsule, solution for injection, cream, etc …
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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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Renewal and annual re-assessment of marketing authorisation
Last updated: 20/06/2022presented, e.g. tablet, capsule, solution for injection, cream, etc … presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Grouping of variations: questions and answers
Last updated: 16/04/2021presented, e.g. tablet, capsule, solution for injection, cream, etc … presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Q&A: Type II variations
Last updated: 21/09/2020 -
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Substance and product data management services (updated)
Last updated: 30/01/2023 -
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Union Product Database: release notes (updated)
Last updated: 31/01/2023