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70 documents on 2 pages
 
close this section of the libraryPrequalification of Medicines
close this section of the libraryWHO-UNICEF-UN Project
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Title: Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2006 Pages: 23
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Regions: Global
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Title: Bill to Provide for the Establishment of Drug Regulatory Authority of Pakistan, 2012
Subjects: Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 28
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Countries: Pakistan
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Title: The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 (Pakistan)
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 1976 Pages: 10
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Countries: Pakistan
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Title: Ensuring Quality Medicines: A Decade of Prequalification
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Author: van Zyl, A. J.
Year: 2011 Pages: 9
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Regions: Global
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Title: Guidance on Variations to a Prequalified Product Dossier. WHO Technical Report Series, No. 943, 2007 Annex 6
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2007 Pages: 50
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Regions: Global
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Title: Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2005 Pages: 49
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Regions: Global
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Title: Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Pages: 11
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Regions: Global
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Title: Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2003 Pages: 4
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Regions: Global
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Title: Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2008 Pages: 10
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Regions: Global
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Title: Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 76
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Regions: Global
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Title: Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 12
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Regions: Global
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Title: Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 2
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Regions: Global
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Title: Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 6
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Regions: Global
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Title: Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2009 Pages: 328
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Regions: Global
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Title: Improving Quality for Better Treatment and Greater Access
Subjects: Medicine Access and Rational Use > Pricing
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 7
Publishers:
Regions: Global
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Title: Inspection of API Manufacturing Sites
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 4
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Regions: Global
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Title: Managing the Tender Process. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 21)
Subjects: Medicine Information and Evidence for Policy > Medicines Policy
Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Author: Clark, Malcolm; Heltzer, Ned; Rankin, James
Year: 2012 Pages: 28
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Regions: Global
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Title: Mechanism to Combat Substandard/Spurious/Falsely-labelled/ Falsified/Counterfeit Medical Products (WHO Drug Information, Vol 27, No. 1, 2013)
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2013 Pages: 2
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Regions: Global; Africa (AFRO)
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Title: A Model Quality Assurance System for Procurement Agencies - Recommendations for Quality Assurance Systems Focusing on Prequalification of Products and Manufacturers, Purchasing, Storage and Distribution of Pharmaceutical Products [French]
Subjects: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2007 Pages: 140
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Regions: Global
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Title: Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 29
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Regions: Global
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Title: PHARMACEUTICAL LICENSING. Following are the Formalities under Rule 16 of the Drugs (Licensing Registering and Advertising Rules 1976). EXTRACTS SRO 470(I)/98 DATED 15.5.1998 SCHEDULE ‘B’ RULE 16(a). SECTION. 1 PREMISES. (Pakistan)
Subjects: Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 1998 Pages: 2
Publishers:
Countries: Pakistan
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Title: Pharmalink Newsletter, Vol 10, Issue 1, October 2010. Assuring the Quality of Medicines [French]
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Author: Bonsmann, Christoph; Haefele-Abah, Christine; Liedtke, Christine; Lwanyaga, Joanita N.; Mohanta, Guru Prasad; Mubangizi, Deusdedit; Nandama, Wycliffe
Year: 2010 Pages: 16
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Regions: Global
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Title: Pre Qualification of Suppliers of Pharmaceuticals and Medical Devices-State Pharmaceuticals Corporation (National Procurement Agency, Sri Lanka)
Subjects: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2007 Pages: 1
Publishers:
Countries: Sri Lanka
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Title: Prequalification of Diagnostics Update, Issue 1, Q1 2008 - Diagnostics and Laboratory Technology
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2008 Pages: 2
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Regions: Global
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Title: Prequalification of Diagnostics Update, Issue 2, Q2 2008 - Diagnostics and Laboratory Technology
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2008 Pages: 2
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Regions: Global
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Title: Prequalification of Diagnostics Update, Issue 3, Q3 2009 - Diagnostics and Laboratory Technology
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2009 Pages: 2
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Regions: Global
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Title: Prequalification of Diagnostics Update, Issue 4, Q3 2010 - Diagnostics and Laboratory Technology
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 2
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Regions: Global
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Title: Prequalification of Diagnostics Update, Issue 5, Q4 2010 - Diagnostics and Laboratory Technology
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 2
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Regions: Global
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Title: Prequalification of Diagnostics Update, Issue 6, Q1 2011 - Diagnostics and Laboratory Technology
Subjects: Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 2
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Regions: Global
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Title: Prequalification of Quality Control Laboratories. Procedure for Assessing the Acceptability, in Principle, of Quality Control Laboratories for Use by United Nations Agencies. WHO Technical Report Series, No. 961, 2011, Annex 12 [French]
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 10
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Regions: Global
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Title: Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 17
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Regions: Global
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Title: Procurement Guidelines, 2006. Goods & Works (National Procurement Agency - Sri Lanka)
Subjects: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2006 Pages: 85
Publishers:
Countries: Sri Lanka
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Title: Programme Activities in 2005: WHO Prequalification Programme [French]
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Medicine Information and Evidence for Policy > Medicines Policy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2005 Pages: 10
Publishers:
Regions: Global
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Title: Quality Assurance for Pharmaceuticals. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 19)
Subjects: Medicine Information and Evidence for Policy > Medicines Policy
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Author: Layloff, Thomas
Year: 2012 Pages: 23
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Regions: Global
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Title: A Rapid Quality Risk Assessment Mechanism for Assessing Needed Pharmaceutical Products that Have Not Completed a Stringent Assessment. WHO Prequalification of Medicines Programme - Briefing Paper: 27 April 2012. Expert Review Panel (ERP)
Subjects: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 13
Publishers:
Regions: Global
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Title: Regulation of Manufacture of Drugs, DRUG ACT, 1976 (Pakistan)
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 1976 Pages: 48
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Countries: Pakistan
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Title: Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953, 2009 - Annex 2. (With Table 2 - Updated 1 December 2010)
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2009 Pages: 50
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Regions: Global
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Title: Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms. WHO Technical Report Series, No. 961, 2011, Annex 5
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 46
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 23, No. 3, 2009 - Recommended INN List 62 - International Nonproprietary Names for Pharmaceutical Substances
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2009 Pages: 78
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 23, No. 4, 2009 - Proposed International Nonproprietary Names, List 102
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > Blood Products and Related Biologicals
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2009 Pages: 97
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 24, No. 1, 2010 - Recommended International Nonproprietary Names, List 63
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 80
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 24, No. 2, 2010 - Proposed International Nonproprietary Names, List 103
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 118
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 24, No. 3, 2010 - Recommended International Nonproprietary Names, List 64
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 92
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 24, No. 4, 2010 - Proposed International Nonproprietary Names, List 104
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2010 Pages: 128
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 25, No. 1, 2011 - Recommended International Nonproprietary Names, List 65
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 98
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 25, No. 2, 2011 - Proposed International Nonproprietary Names, List 105
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 120
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 25, No. 4, 2011 - Proposed International Nonproprietary Names, List 106
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 125
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 26, No. 1, 2012 - Recommended International Nonproprietary Names, List 67
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 96
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 26, No. 2, 2012 - Proposed International Nonproprietary Names, List 107
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 139
Publishers:
Regions: Global
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Title: WHO Drug Information Vol. 26, No. 3, 2012 - Recommended International Nonproprietary Names, List 68
Subjects: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 100
Publishers:
Regions: Global
 
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Last updated: May 3, 2013