Additional guidance on documents relating to an active substance master file

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 …

   http://www.ema.europa.eu/docs/en_GB/document…/WC500002814.pdf‎

   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 …

   http://www.ema.europa.eu/ema/pages/includes/…/open_document.jsp?…‎

   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 …

   http://www.ema.europa.eu/ema//index.jsp?curl=pages/contacts/CHMP/…‎

   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  …

   ‎Description – ‎DMFs in the United States – ‎DMFs in Europe – ‎References

5. Submission requirements for Active Substance Master Files : MHRA

   http://www.mhra.gov.uk/…/SubmissionrequirementsforActiveSubstanceMaster…‎

   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 …

   http://www.raps.org › Focus Online › News › News – Article View‎

   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 …

   http://www.raps.org › Focus Online › News › News – Article View‎

   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

   http://www.gmp-compliance.org/eca_news_3357_7400,S-WKS.html‎

   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 …

   http://www.gmp-compliance.org/eca_guideline_3426.html‎

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

Construction of the european drug master file from GlobalCompliancePanel

Advertisement