Transcription of MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: …
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MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: …
working document July 2014 document for comment 1 2 MULTISOURCE ( generic ) PHARMACEUTICAL 3 PRODUCTS: GUIDELINES ON REGISTRATION 4 REQUIREMENTS TO ESTABLISH 5 INTERCHANGEABILITY. REVISION 6 (JULY 2014) 7 8 REVISED DRAFT FOR COMMENT 9 10 11 World Health Organization 2014 12 All rights reserved. 13 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. 14 The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or 15 in whole, in any form or by any means outside these individuals and organizations (including the organizations' 16 concerned staff and member organizations) without the permission of the World Health Organization. The draft should 17 not be displayed on any website. 18 Please send any request for permission to: 19 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, Department of 20 Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.
Working document QAS/14.583/Rev.1 page 3 43 BACKGROUND 44 Over the course of time and especially in view of the implementation of the existing 45 guidelines 1 the users have indicated that there was a need to review and update certain 46 requirements.
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