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GUIDANCE ON VARIATIONS TO A PREQUALIFIED DOSSIER - …
Working document RESTRICTED GUIDANCE ON VARIATIONS TO A PREQUALIFIED DOSSIER World Health Organization 2006 All rights reserved. This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations concerned staff and member organizations) without the permission of WHO. The draft should not be displayed on any website. Please send any request for permission to: Dr Matthias Stahl, Quality Assurance & Safety: Medicines (QSM), Department of Medicines Policy and Standards (PSM), World Health Organization, CH-1211 Geneva 27, Switzerland, Fax: (41-22) 791 4730; e-mail: The designations employed and the presentation of the material in this draft do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the
Working document QAS/05.150/Rev.1 page 3 Page 3 of 44 Variation Guide 14/09/2006 GUIDANCE ON VARIATIONS TO A PREQUALIFIED DOSSIER PREFACE This guidance document was technically and structurally inspired by the "Guideline on
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