substance master file

Additional guidance on documents relating to an active substance master file

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Additional guidance on documents relating to an active substance master file

EMA DOWNLOAD

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/10/WC500133204.pdf

  1. Guideline on Active Substance Master File – European Medicines

    Apr 15, 2005 – The main objective of the Active Substance Master File (ASMF) procedure, commonly known as the European Drug Master File (EDMF) 

  2. Guideline on Active Substance Master File Procedure – European

    Active substance master file, ASMF, letter of access, submission letter. 7 Westferry Circus Content of the MA-dossier when the Active Substance Master File.

  3. European Medicines Agency – CHMP – Active Substance Master File

    Heads of Medicines Agencies: Active Substance Master File Working Group · Home · Find medicine · Regulatory · Special topics · Document search · News & 

  4. Drug Master File – Wikipedia, the free encyclopedia

    en.wikipedia.org/wiki/Drug_Master_File

    It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States 

  5. Submission requirements for Active Substance Master Files : MHRA

    Jul 3, 2012 – The following submission guidance is aimed towards the holders of Active Substance Master Files (ASMFs). Since an ASMF is submitted as 

  6. EMA Releases New Guideline on Active Substance Master File

    Jan 20, 2012 – The European Medicines Agency released its Guideline on Active Substance Master File (ASMF) Procedure yesterday that aims to improve the 

  7. EMA Releases Updated Final Guideline on Active Substance Master

    Jul 13, 2012 – A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) 

  8. Additional Guidance Document on Active Substance Master File

    GMP News 17/10/2012. Additional Guidance Document on Active Substance Master File (ASMF) published by EMA. The European Medicines Agency (EMA) 

  9. GMP Guideline Guideline on Active Substance Master File

    Guideline on Active Substance Master File Procedure (CPMP/QWP/ 227/02 Rev. 2). Short Title: CPMP/QWP/ 227/02 Rev. 2. Internet 

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