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Eudralex Volume 3 Note for Guidance on Manufacture of the Finished Dosage Form

Short Title:
EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1
Origin/Publisher:

EMEA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel (44-20-7) 418 8400, Fay (44-20-7) 418 85 95 info@ema.europa.eu; http://www.emaea.europa.eu

Document Type:
Guideline
Content:
Guidance on the background and the interpretation of some aspects of the text of the directive 65/65/EEC (Annex, Part 2 of 91/507/EEC) which states that an application for a marketing authorisation shall contain a brief description of the manufacturing process

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