WHO Publications - Non WHO Publications - All
English - French - Spanish - Russian
Expand the sub-collections menu.
61 documents on 4 pages
 
close this section of the libraryPrequalification of Medicines
close this section of the libraryWHO-UNICEF-UN Project
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Open this document and view its content
Title: Inspection of API Manufacturing Sites
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 4
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global; Africa (AFRO)
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Related documents:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
Open this document and view its content
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
Publishers:
Regions: Global
 
1  2  3  4   Next »
 

Last updated: May 3, 2013