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Quality and Safety: Medicines

Quality Assurance

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Título:	13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2008 Páginas: 19
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regiones:	Global

Título:	14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2011 Páginas: 16
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html

Título:	Accelerated Stability Studies of Widely Used Pharmaceutical Substances Under Simulated Tropical Conditions
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	1986 Páginas: 119
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2006 Páginas: 23
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report Proposal to Waive in Vivo Bioequivalence Requirements for WHO Model List of Essential Medicines Immediate-release, Solid Oral Dosage Forms. WHO Technical Report Series, No. 937, 2006, Annex 8
Regiones:	Global

Título:	Antimalarial Medicines in Kenya. Availability, Quality and Registration Status. A Baseline Study Undertaken Prior to Nationwide Distribution of Artemether-Lumefantine (AL) in Kenya
Temas:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Quality Assurance
Año:	2007 Páginas: 41
Publicadores:	WHO Country Office in Kenya Kenya Ministry of Health Health Action International - Africa
Regiones:	EAC East African Community
Países:	Kenya

Título:	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2003 Páginas: 14
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Basic Tests for Drugs - Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms [French] [Spanish]
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	1998 Páginas: 100
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Basic Tests for Pharmaceutical Substances [French] [Spanish]
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	1986 Páginas: 216
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2002 Páginas: 4
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Regiones:	Global

Título:	Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2012 Páginas: 29
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html http://www.who.int/childmedicines/en/
Regiones:	Global

Título:	Drug Quality Control Laboratories
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	1999 Páginas: 42
Publicadores:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Documentos relacionados:	Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Regiones:	África (AFRO)

Título:	Drug Quality Screening in Developing Countries: Establishment of an Appropriate Laboratory in Swaziland
Temas:	Quality and Safety: Medicines > Quality Assurance
Autore:	Kenyon, A.S.; Kenyon, T.A.; Sibiya, T.
Año:	1994 Páginas: 6
Publicadores:	WHO Headquarters in Geneva
Países:	Swazilandia

Título:	Serie sobre Investigaciones [French] [Spanish]
Temas:	Medicine Access and Rational Use > Financing Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Quality Assurance
Publicadores:	WHO Headquarters in Geneva

Título:	Ensuring Quality Medicines: A Decade of Prequalification
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Autore:	van Zyl, A. J.
Año:	2011 Páginas: 9
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Framework for Implementation of Equivalence Requirements for Pharmaceutical Products. PANDRH Technical Report Nº 8, Pan American Network on Drug Regulatory Harmonization
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2011 Páginas: 38
Publicadores:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regiones:	Global; Américas (AMRO)

Título:	Good Manufacturing Practices for Biological Products. In: WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822), Annex 1; and WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834), Annex 3
Temas:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Año:	1992 Páginas: 11
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Expert Committee on Biological Standardization - WHO Technical Report Series, No. 822 - Forty-second Report WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:	Global

Título:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans. WHO Technical Report, Series No. 863 , 1996, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	1996 Páginas: 16
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:	Global

Título:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	1999 Páginas: 22
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:	Global

Título:	Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria
Temas:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Año:	2011 Páginas: 109
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Good Procurement Practices for Artemisinin-Based Antimalarial Medicines
Temas:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Año:	2010 Páginas: 128
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2003 Páginas: 19
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
Regiones:	Global

Título:	Guidance for Inspection of Drug Distribution Channels. WHO Technical Report Series, No. 885, 1999, Annex 6
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	1999 Páginas: 21
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:	Global

Título:	Guidance on Good Manufacturing Practices (GMP): Inspection Report. WHO Technical Report Series, No. 908, 2003, Annex 6
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2003 Páginas: 5
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:	Global

Título:	Guidance on the Selection of Comparator Pharmaceutical Products for Equivalence Assessment of Interchangeable Multisource (Generic) Products. WHO Technical Report Series, No. 902, 2002, Annex 11
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2002 Páginas: 20
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regiones:	Global

Título:	Guidance on Variations to a Prequalified Product Dossier. WHO Technical Report Series, No. 943, 2007 Annex 6
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2007 Páginas: 50
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guide to Good Storage Practices for Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 9
Temas:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Año:	2003 Páginas: 12
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2005 Páginas: 49
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2003 Páginas: 4
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2008 Páginas: 10
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	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
Regiones:	Global

Título:	Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009 [Portuguese] [Spanish]
Temas:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Año:	2009 Páginas: 34
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products. WHO Technical Report Series, No. 908, 2003, Annex 3
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2003 Páginas: 10
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regiones:	Global

Título:	Guidelines on Packaging for Pharmaceutical Products. WHO Technical Report Series, No. 902, 2002, Annex 9
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2002 Páginas: 38
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regiones:	Global

Título:	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
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2012 Páginas: 76
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3 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 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 Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Regiones:	Global

Título:	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
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2011 Páginas: 12
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	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 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
Regiones:	Global

Título:	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
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2011 Páginas: 2
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	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 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
Regiones:	Global

Título:	Guiding Principles to Ensure Injection Device Security
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Año:	2003 Páginas: 2
Publicadores:	WHO Headquarters in Geneva

Título:	Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2009 Páginas: 328
Publicadores:	WHO/TDR - World Health Organization Special Programme for Research and Training in Tropical Diseases WHO Headquarters in Geneva The World Bank (WB) United Nations Children's Fund (UNICEF) United Nations Development Programme (UNDP)
Documentos relacionados:	Handbook: Non-Clinical Safety Testing
Regiones:	Global

Título:	Improving Quality for Better Treatment and Greater Access
Temas:	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
Año:	2012 Páginas: 7
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Inspection of API Manufacturing Sites
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2011 Páginas: 4
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services. WHO Technical Report Series, No. 961, 2011, Annex 8
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Año:	2011 Páginas: 14
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Malaria Microscopy Quality Assurance Manual. Version 1
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2009 Páginas: 149
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Mechanism to Combat Substandard/Spurious/Falsely-labelled/ Falsified/Counterfeit Medical Products (WHO Drug Information, Vol 27, No. 1, 2013)
Temas:	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
Año:	2013 Páginas: 2
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Drug Information Vol. 27, No. 1, 2013 - Recommended International Nonproprietary Names, List 69
Regiones:	Global; África (AFRO)

Título:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2002 Páginas: 4
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Regiones:	Global

Título:	Model Certificate of Good Manufacturing Practices. WHO Technical Report Series, No. 908, 2003, Annex 5
Temas:	Quality and Safety: Medicines > Quality Assurance
Año:	2003 Páginas: 4
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:	Global

Título:	Model Guidance for the Storage and Transport of Time and Temperature-sensitive Pharmaceutical Products. WHO Technical Report Series, No.961, 2011, Annex 9
Temas:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Año:	2011 Páginas: 49
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Regiones:	Global

Título:	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]
Temas:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2007 Páginas: 140
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2006 Páginas: 44
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regiones:	Global

Título:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2012 Páginas: 29
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	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
Regiones:	Global

Título:	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]
Temas:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2011 Páginas: 10
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Procedure for Assessing the Acceptability, in Principle, of Procurement Agencies for Use by United Nations Agencies. WHO Technical Report Series, No. 917, 2003, Annex 6
Temas:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Año:	2003 Páginas: 10
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 917 - Thirty-eighth Report
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Regiones:	Global


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Última actualización: le 3 mayo 2013