ASMF

Results: 21



#Item
1

SOP on DCP latest updates Virginie Bacquet CMDh meeting: May 2016 Update 1: ASMF

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Source URL: www.hma.eu

- Date: 2016-06-27 11:00:08
    2

    ASMF Q-A_CMDh_280_2012_Rev06_2015-05_update-VET references

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    Source URL: www.hma.eu

    - Date: 2016-05-20 06:59:26
      3

      ASMF Q-A_CMDh_280_2012_Rev06_2015-05_update-VET references

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      Source URL: www.hma.eu

      - Date: 2016-05-20 06:59:26
        4Pharmaceutical industry / Clinical data management / Health informatics / Agencies of the European Union / Clinical research / Electronic common technical document / European Medicines Agency / Marketing authorization / ASMF / EMA

        Annex1 - A guide to the filenaming convention for eSubmission

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        Source URL: esubmission.ema.europa.eu

        Language: English - Date: 2016-08-19 03:16:00
        5Clinical research / Clinical data management / Pharmaceutical industry / Electronic common technical document / Pharmaceuticals policy / Common Technical Document / Marketing authorization / ASMF / European Medicines Agency / European Directorate for the Quality of Medicines / Dossier / Electronic submission

        Revision version 1.5 for public consultation Comments byJune 2016

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        Source URL: esubmission.ema.europa.eu

        Language: English - Date: 2016-08-19 03:14:57
        6Clinical research / Clinical data management / Electronic common technical document / Digital media / Research / Common Technical Document

        Mandatory eCTD for Human centralised procedure ASMF submissions - Statement of Intent

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        Source URL: esubmission.ema.europa.eu

        Language: English - Date: 2016-08-19 03:14:57
        7Clinical research / Clinical data management / Electronic common technical document / Pharmaceutical industry / Common Technical Document / Pharmaceuticals policy / Marketing authorization / ASMF / Portable Document Format

        London, January, 2010 EMA

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        Source URL: esubmission.ema.europa.eu

        Language: English - Date: 2016-08-18 07:12:04
        8

        06.10b - GL on ASMF - Rev 03 Corr for May QWP Adoption

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        Source URL: www.ema.europa.eu

        Language: English - Date: 2013-07-21 06:33:35
          9Marketing authorization / Marketing Authorization Application / Pharmaceutical industry / Pharmaceuticals policy / Drug safety

          CMDh QUESTIONS & ANSWERS ACTIVE SUBSTANCE MASTER FILE (ASMF) Doc. Ref.: CMDh, Rev.5 JanuaryIn order to enhance transparency between the applicant and the ASMF holder and to facilitate

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          Source URL: www.hma.eu

          Language: English - Date: 2015-02-19 09:47:04
          10Marketing authorization / Marketing Authorization Application / Pharmaceutical industry / Pharmaceuticals policy / Drug safety

          CMDh QUESTIONS & ANSWERS ACTIVE SUBSTANCE MASTER FILE (ASMF) Doc. Ref.: CMDh, Rev.5 JanuaryIn order to enhance transparency between the applicant and the ASMF holder and to facilitate

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          Source URL: www.hma.eu

          Language: English - Date: 2015-02-19 09:47:04
          UPDATE