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Q&A: Type II variations vs Extension applications
Last updated: 18/06/2019replacement of a presentation for a solution for injection with a different … presentation for an eye-drop solution with a different immediate …
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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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Conduct of bioequivalence studies for veterinary medicinal products
Last updated: 26/07/2021presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Big data
Last updated: 06/09/2021Institute d/b/a RTI Health Solutions Single-arm studies with historical …
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Coordination of Pharmacovigilance inspections
Last updated: 24/02/2015software-as-a-service (SaaS or cloud solution). Different requirements will …
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Quality of medicines questions and answers: Part 2
Last updated: 11/12/2018storage or handling of a liquid solution,is the inclusion of a mandatory …
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Certification of medicinal products
Last updated: 03/05/2021presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Scientific advice and protocol assistance
Last updated: 28/10/2021identifies questions and possible solutions. EMA then gives advice on …
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Fees payable to the European Medicines Agency
Last updated: 15/05/2020presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Pre-authorisation guidance under the Veterinary Medicinal Products Regulation
Last updated: 27/07/2021presented, e.g. tablet, capsule, solution for injection, cream, etc …
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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)
Last updated: 21/05/2010presented, e.g. tablet, capsule, solution for injection, cream, etc …
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Type-IB variations: questions and answers
Last updated: 22/01/2020for the pharmaceutical form 'solution for injection'. The MAH intends …
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Type-IA variations: questions and answers
Last updated: 22/01/2020the pharmaceutical form ‘solution for injection’. The MAH …
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Union Product Database (updated)
Last updated: 29/11/2021 -
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Pharmacovigilance (updated)
Last updated: 18/11/2021 -
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Veterinary product information templates
Last updated: 18/10/2021 -
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EudraVigilance Veterinary
Last updated: 30/09/2021 -
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Use of macrolides, lincosamides and streptogramins in food-producing animals in the European Union: development of resistance and impact on human and animal health
Last updated: 15/10/2021 -
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Determination of withdrawal periods for milk
Last updated: 15/10/2021 -
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Demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish
Last updated: 26/07/2021 -
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Manufacture of the finished dosage form (veterinary)
Last updated: 23/07/2021 -
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Dossier requirements for anticancer medicinal products for dogs and cats
Last updated: 26/07/2021 -
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Demonstration of palatability of veterinary medicinal products
Last updated: 26/07/2021 -
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Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU
Last updated: 26/07/2021