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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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Medicine evaluation figures
Last updated: 15/10/202115/11/2021 EMA/641328/2021 Generic Medicinal products for human … 15/10/2021 EMA/582623/2021 Generic Medicinal products for human … 17/09/2021 EMA/526215/2021 Generic Medicinal products for human …
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Union Product Database (updated)
Last updated: 29/11/202117/05/2021 EMA/104493/2021 Generic EU Implementation Guide (Vet … 17/05/2021 EMA/257565/2021 Generic EU Implementation Guide (IG … 17/05/2021 EMA/104800/2021 Generic EU Implementation Guide (IG …
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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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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 the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances
Last updated: 28/06/2021EMEA/CVMP/SAGAM/383441/2005 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: 18/06/202114/12/2018 EMA/113700/2008 Rev.1 Generic Document history EudraVigilance … 01/01/2022 EMA/113700/2008 Generic Draft EudraVigilance access … 12/03/2021 EMA/113700/2008 Rev.2 Generic EudraVigilance access policy …
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Parallel distribution: Regulatory and procedural guidance
Last updated: 09/06/202109/06/2021 EMA/297155/2021 Generic List of centrally authorised … 01/12/2021 EMA/579235/2021 Corr.1 Generic Checklist for initial notifications … 02/08/2021 EMA/267299/2020 Rev. 2 Generic Checklist for annual updates …
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CVMP: Agendas, minutes and reports
Last updated: 08/09/202003/11/2021 EMA/619106/2021 Generic Agenda - CVMP agenda of the … 04/10/2021 EMA/556577/2021 Generic Agenda - CVMP agenda of the … 07/09/2021 EMA/497915/2021 Generic Agenda - CVMP agenda of the …
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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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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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Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
Last updated: 25/02/2021EMA/CVMP/SWP/66781/2005–Rev.1 Generic Overview of comments received … EMA/CVMP/SWP/523387/2016 Generic Draft guideline on safety … EMA/CVMP/QWP/66781/2005 Rev.1 Generic …
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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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Fixed combination products
Last updated: 26/07/2021EMA/CVMP/83804/2005-Rev.1 Generic Document history Guideline … 01/07/2007 EMEA/CVMP/83804/2005 Generic Questions and answers on … EMA/CVMP/EWP/325284/2011 Rev.1 Generic Overview of comments received …
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Application guidance
Last updated: 10/07/202016/02/2021 EMA/466102/2007 Rev. 33 Generic Recommended submission dates … 11/01/2021 EMA/473691/2020 Generic Information on summary of … change_of_applicant_-_cover_letter_standard_text_en.docx 01/10/2018 Generic Change of applicant checklist …
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CVMP: meeting archive 2016-2018
Last updated: 09/11/201804/12/2018 EMA/CVMP/812471/2018 Generic Agenda - CVMP agenda of the … EMA/CVMP/770637/2018 - draft 2 Generic Agenda - CVMP agenda of the … 10/10/2018 EMA/CVMP/662126/2018 Generic Agenda - CVMP agenda of the …
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Quality of water for pharmaceutical use
Last updated: 01/02/2021EMA/CHMP/CVMP/QWP/496873/2018 Generic Document history Guideline … EMA/CHMP/CVMP/QWP/496873/2018 Generic Overview of comments received … EMA/CHMP/CVMP/QWP/230700/2020 Generic Draft guideline on the quality …
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Veterinary Medicinal Products Regulation
Last updated: 31/03/2021vmp_reg_newsletter_-_issue_8_en.pdf 29/11/2021 Issue 8 Generic Veterinary Medicines Regulation … vmp_reg_newsletter_-_issue_7_en.pdf 01/10/2021 Issue 7 Generic Veterinary Medicines Regulation … vmp_reg_newsletter_-_issue_6_4_en.pdf 29/07/2021 Issue 6 Generic Veterinary Medicines Regulation …
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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 …
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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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Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products
Last updated: 01/03/2021reflection_paper_on_antimicrobials_in_the_environment_en.pdf Adopted 01/03/2021 Generic Document history Reflection … reflection_paper_on_antimicrobials_in_the_environment_en.pdf Adopted 01/03/2021 Generic Overview of comments received … EMA/CVMP/ERA/268948/2020 Generic Draft reflection paper on …
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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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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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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 …