16494 results
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Key documents
Last updated: 21/12/2020Key documents … Agency (EMA) makes available documents on key areas of the EMA's … https://www.ema.europa.eu/documents/other/revised-framework-interaction-between-european-medicines-agency-healthcare-professionals-their_en.pdf …
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Key documents
Last updated: 21/12/2020Key documents … Key documents …
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Guidance documents
Last updated: 20/04/2020Guidance documents … Guidance documents … of a question and answer document, is intended to clarify how …
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COMP Documents
Last updated: 31/12/2009COMP Documents … COMP Documents …
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CAT Documents
Last updated: 31/12/2009CAT Documents … following list is the latest documents for the CAT committee Topics: …
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HMPC Documents
Last updated: 31/12/2009HMPC Documents … following list is the latest documents for the HMPC committee …
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CVMP Documents
Last updated: 31/12/2009CVMP Documents … following list is the latest documents for the CVMP committee …
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PDCO Documents
Last updated: 31/12/2009PDCO Documents … following list is the latest documents for the PDCO committee Topics: …
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Biologics Working Party documents
Last updated: 30/03/2021Biologics Working Party documents … Biologics Working Party documents … virus 1 This amended document includes a recommendation …
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Non-clinical Working Party documents
Last updated: 05/04/2023Non-clinical Working Party documents … Working Party (NcWP) publishes documents related to its work on this … its work on this page. Some document titles mention the retired Safety …
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Access to documents
Last updated: 23/11/2018Access to documents … widest possible access to its documents following requests from the … on access to unpublished documents Access to Documents Service First publication …
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Marketing authorisation guidance documents
Last updated: 01/06/2016eting authorisation guidance documents … eting authorisation guidance documents …
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Superseded pharmacovigilance guidance documents
Last updated: 12/04/2013pharmacovigilance guidance documents … pharmacovigilance guidance documents … and/or distribution of this document is authorised for non commercial …
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Document and information management
Last updated: 31/12/2009Document and information management … Generic Work instructions on documentation of external requests for … translation workflow of EMA documents PDF icon application/pdf …
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Haematology Working Party documents
Last updated: 31/12/2009Haematology Working Party documents … Haematology Working Party documents … London, 24 January 2008 Doc. Ref. EMEA/CHMP/BPWP/361857/2006 …
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Core management documents
Last updated: 26/05/2010Core management documents …
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Vaccines Working Party documents
Last updated: 23/11/2009Vaccines Working Party documents … and/or distribution of this document is authorised for non commercial … London, 16 January 2007 Doc. Ref: EMEA/CHMP/VWP/14684/2007 …
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Efficacy Working Party documents
Last updated: 23/11/2009Efficacy Working Party documents … and/or distribution of this document is authorised for non commercial … London, 13 December 2007 Doc. Ref. EMEA/CHMP/EWP/490784/2007 …
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Press release: EMA reviewing cancer medicine docetaxel
PRAC, Last updated: 10/03/2017EMA reviewing cancer medicine docetaxel … investigating the cancer medicine docetaxel following cases of neutropenic … known and rare side effect of docetaxel (which may affect up to one … -
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All herbal documents under consultation
Last updated: 01/01/2015All herbal documents under consultation … The herbal documents listed on this page are currently …
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Enpr-EMA meeting documents archive
Last updated: 25/07/2019Enpr-EMA meeting documents archive … archive contains the meeting documents of the coordinating group … meetings and related meeting documents, see Enpr-EMA governance …
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Product information: Reference documents and guidelines
Last updated: 31/12/2020oduct information: Reference documents and guidelines … oduct information: Reference documents and guidelines … vaccines Quality Review of Documents (QRD) group 1. Introduction …
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Working Group on Quality Review of Documents
Last updated: 31/12/2009Group on Quality Review of Documents … Group on Quality Review of Documents … Party on Quality Review of Documents (QRD) 1 July 2014 EMA/403106/2014 …
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Product information: Reference documents and guidelines
Last updated: 31/12/2009oduct information: Reference documents and guidelines … oduct information: Reference documents and guidelines …
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Plasma Master File (PMF) background documents
Last updated: 31/12/2009Master File (PMF) background documents … Master File (PMF) background documents …