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WHO Guidelines on active pharmaceutical ingredient master file procedure

Short Title:
Annex 4, WHO Technical Report Series 948, 2008

WHO headquarters, Avenue Appia 20, 1211 Geneva 27, Switzerland Telephone: (+ 41 22) 791 21 11, Facsimile (fax): (+ 41 22) 791 3111, Telex: 415 416, Telegraph: UNISANTE GENEVA

These guidelines are intended to assist applicants in the compilation of the information on APIs in their dossiers for prequalification or when submitting a variation to a dossier on a prequalifi ed product (named in the text from now on as product dossier) when the APIMF procedure is used. It is also intended to help APIMF holders in the compilation of their APIMFs.

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