The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 3 Guideline on Manufacture of the Finished Dosage Form

Short Title:

EMEA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel (44-20-7) 418 8400, Fay (44-20-7) 418 85 95;

Document Type:
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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