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Dissolution specification for generic oral immediate release products
Last updated: 15/08/2017Dissolution specification for generic oral immediate release produc … dissolution of orally administered generic drug products with immediate … dissolution specification for generic solid oral immediate release …
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Herbal medicinal product: Passiflorae herba
Passiflora incarnata L., Passion Flower, F: Assessment finalised, Last updated: 06/10/2016 -
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CVMP: Agendas, minutes and reports (updated)
Last updated: 24/06/202214/06/2022 EMA/583174/2022 Generic Agenda - CVMP agenda of the … 10/05/2022 EMA/258586/2022 Generic Agenda - CVMP agenda of the … 11/04/2022 EMA/213330/2022 Generic Agenda - CVMP agenda of the …
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Application guidance
Last updated: 10/03/202216/02/2021 EMA/466102/2007 Rev. 33 Generic Recommended submission dates … 08/06/2022 EMA/587410/2021 Rev.5 Generic Information on A document … EMA/CVMP/32995/2006 Rev. 1 Generic Change of applicant - Cover …
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Sampling and testing
Last updated: 28/03/2019it will: expand the generics programme by increasing the … 7 3.4. Generics programme … 10 5.3. Generic programmes …
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Fees payable to the European Medicines Agency
Last updated: 01/04/2022explanatory_note_on_general_fees_payable_to_the_ema_april_2022_en.pdf 01/04/2022 Generic Fees for human pharmacovigila …
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Injection-site residues
Last updated: 25/03/202213/04/2005 EMEA/CVMP/542/03-FINAL Generic Document history Adopted … EMA/CVMP/SWP/185470/2004 Rev.1 Generic Overview of comments received … 25/03/2022 EMA/CVMP/SWP/11010/2022 Generic Draft guideline on injection …
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Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances
Last updated: 28/01/2022EMA/CVMP/383441/2005-Rev.1 Generic Document history - Revision … EMA/CVMP/383441/2005-Rev.1 Generic Overview of comments received … 28/06/2021 EMA/CVMP/692904/2018 Generic Draft guideline on the summary …
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EudraVigilance access policy for medicines for veterinary use
Last updated: 04/01/2022EMA/113700/2008 Rev. 2.1 Generic Document history EudraVigilance … EMA/113700/2008 Rev. 2.1 Generic Draft EudraVigilance access … 12/03/2021 EMA/113700/2008 Rev.2 Generic EudraVigilance access policy …
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Key documents
Last updated: 21/12/2020Adopted 14/02/2006 07/02/2022 Generic Rules of engagement for patients’ … rules_on_engagement_for_organisations_involved_in_repurposing_en.pdf 06/07/2020 Generic Criteria to be fulfilled … 11/06/2018 EMA/MB/24913/2005 Rev.3 Generic Principles on the involvement …
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Quality of herbal medicinal products/traditional herbal medicinal products
Last updated: 12/05/2022EMA/HMPC/CHMP/CVMP/201116/20051 Rev. 3 Generic Document history - Revision … 30/11/2018 EMA/HMPC/201116/2005 Generic Concept paper on the revision … 31/08/2015 EMA/HMPC/217631/2015 Generic Document history - Revision …
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Veterinary Medicinal Products Regulation
Last updated: 28/01/2022vmp_reg_newsletter_-_issue_10_en.pdf 17/05/2022 Issue 10 Generic Veterinary Medicinal Products … vmp_reg_newsletter_-_issue_9_en.pdf 07/02/2022 Issue 9 Generic Veterinary Medicinal Products … vmp_reg_newsletter_-_issue_8_en.pdf 29/11/2021 Issue 8 Generic Veterinary Medicinal Products …
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Product information: Reference documents and guidelines
Last updated: 31/12/202018/06/2021 EMA/343077/2021 rev.2 Generic Compilation of Quality Review … 31/10/2020 EMA/25090/2002 Rev. 21 Generic Member states contact points … 31/12/2020 EMA/358267/2015 Rev.6 Generic List of official languages …
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Parallel distribution: Regulatory and procedural guidance
Last updated: 09/06/202131/05/2022 EMA/297155/2021 Rev. 2 Generic List of centrally authorised … 16/06/2022 EMA/591686/2022 Generic Checklist for initial notifications … 02/08/2021 EMA/267299/2020 Rev. 3 Generic Checklist for annual updates …
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CVMP strategy on antimicrobials 2021-2025
Last updated: 02/02/202102/02/2021 EMA/CVMP/179874/2020 Generic Document history Overview … 02/02/2021 EMA/CVMP/517722/2020 Generic Draft CVMP strategy on antimicrobials … 30/09/2020 EMA/CVMP/179874/2020 Generic CVMP strategy on antimicrobials …
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Methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunulogical veterinary medicinal products
Last updated: 17/09/2021EMA/CVMP/IWP/251741/2015 Generic Document history Revision … EMA/CVMP/IWP/251741/2015 Rev. 1 Generic Overview of comments received … EMA/CVMP/IWP/408557/2021 Generic Draft reflection paper on …
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Guideline on clinical trials with immunological veterinary medicinal products
Last updated: 28/01/2022EMA/CVMP/IWP/260956/2021 Generic Document history - Revision … EMA/CVMP/IWP/260956/2021 Generic Overview of comments received … EMA/CVMP/IWP/618327/2021 Generic Draft concept paper on the …
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Linguistic review
Last updated: 08/02/202107/02/2011 EMEA/288844/2009 Rev 4* Generic Product-information-quality … WC500004328_en.doc 19/06/2009 06/05/2010 Generic QRD Form 1: For Member States' … WC500004330_en.doc 19/06/2009 10/06/2015 Generic Member states contact points …
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Quality aspects of pharmaceutical veterinary medicines for administration via drinking water
Last updated: 28/01/2022EMA/CVMP/QWP/697426/2021 Generic Guideline on quality aspects … 15/01/2005 EMEA/CVMP/540/03 Rev 1 Generic Document history Concept … 13/11/2002 EMEA/CVMP/1055/02 Generic Topics: Guidance Scientific …
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Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
Last updated: 17/02/2020EMA/CVMP/QWP/631010/2017 Rev.2 Generic Reflection paper on risk … EMA/CVMP/QWP/153641/2018 Generic Document history Implementation … EMA/CVMP/QWP/631010/2017 Rev.2 Generic Overview of comments received …
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Article 30(3) opinions
Last updated: 11/12/201804/02/2013 EMA/CVMP/392253/2012 Generic CVMP assessment report under … 04/02/2013 EMA/CVMP/392271/2012 Generic Histamine residues in veterinary … 30/11/2018 EMA/CVMP/766265/2018 Generic Opinion of the Committee …
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Public bulletins: Veterinary pharmacovigilance
Last updated: 26/02/2016EMA/CVMP/PhVWP/33617/2020 Generic Public bulletin: Veterinary … 17/05/2019 EMA/CVMP/809750/2018 Generic Public bulletin: Veterinary … WC500246339_en.pdf 22/03/2018 22/03/2018 Generic Public bulletin: Veterinary …
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Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation
Last updated: 13/01/2021and the European Group for Generic Veterinary Products (EGGVP … and the European Group for Generic Veterinary Products (EGGVP …
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Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products
Last updated: 31/01/202017/09/2015 EMA/CVMP/ERA/52740/2012 Generic Document history Question … 31/01/2020 EMA/593989/2019 Generic Guideline on the assessment … 17/09/2015 EMA/CVMP/ERA/52740/2012 Generic Overview of comments received …
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Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health
Last updated: 01/03/2021EMA/CVMP/AWP/842786/2015 Generic Document history Reflection … EMA/CVMP/AWP/842786/2015 Generic Overview of comments received … EMA/CVMP/AWP/902538/2019 Generic Draft reflection paper on …