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Title: Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
Subjects: Quality and Safety: Medicines > Regulatory Support
Year: 2010 Pages: 48
Publishers:
Regions: Africa (AFRO)
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Title: Autorisation de mise sur le marché des médicaments à usage humain notamment d'origine multisource (génériques). Manuel à l’usage des autorités de réglementation pharmaceutique - Série Réglementation Pharmaceutique, No. 13
Year: 2008 Pages: 236
Publishers:
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
Publishers:
Regions: Global
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Title: Guidelines for Registration of Traditional Medicines in the WHO African Region
Subjects: Traditional Medicine > Traditional, Complementary and Herbal Medicine
Quality and Safety: Medicines > Regulatory Support
Year: 2010 Pages: 40
Publishers:
Related links:
Regions: Africa (AFRO)
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Title: Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for National Medicines Regulatory Authorities (NMRAs) – 2nd Edition
Subjects: Quality and Safety: Medicines > Regulatory Support
Year: 2011 Pages: 148
Publishers:
Regions: Global
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Title: Model Certificate of Good Manufacturing Practices. WHO Technical Report Series, No. 908, 2003, Annex 5
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2003 Pages: 4
Publishers:
Related links:
Regions: Global
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Title: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 2006 Pages: 44
Publishers:
Related links:
Regions: Global
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Title: Requisitos armonizados para el registro de vacunas en la Región de las Américas y Guía para la preparación de una solicitud de registro sanitario. Red PARF Documento Técnico No. 1 (Red Panamericana de Armonización de la Reglamentación Farmacéutica), Noviembre de 2008
Subjects: Calidad y seguridad de los medicamentos > Garantía de calidad
Calidad y seguridad de los medicamentos > Apoyo en materia de reglamentación
Calidad y seguridad de los medicamentos > Seguridad y eficacia
Year: 2010 Pages: 38
Publishers:
Regions: America (AMRO)
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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
Publishers:
Regions: Global
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Title: WHO Medicines Regulatory Package. A Collection of Tools for Medicines Regulatory Authorities - Regulatory Support Series No. 014
Year: 2011
Publishers:
Regions: Global
 

Last updated: May 3, 2013