Regulación 29/02 - Cecmed - Infomed

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BIBLIOGRAFÍA1. Requisitos para las solicitudes de Inscripción, Renovación y Modificación en elRegistro de Medicamentos de uso Humano, 2 000.2. Lineamientos de la OMS para Evaluación de Medicamentos Herbarios. Juana Mejíade Rodríguez. CYTED. 2da. Reunión de Coordinación Internacional de la RedIberoamericana de Productos Fitofarmacéuticos (Riprofito). Pág 41.3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtyfourthreport of the WHO Expert Committee. Geneva, World Health Organization, 1996( WHO Technical Report Series, No. 863).4. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twentyninthreport. Geneva, World Healt Organization, 1984 ( WHO Technical Report Series,No. 704).5. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtysecondreport. Geneva, World Healt Organization, 1992 ( WHO Technical ReportSeries, No. 823).6. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtythirdreport. Geneva, World Healt Organization, 1993 ( WHO Technical Report Series,No. 834).7. Legislación en Iberoamérica sobre Fitofármacos y Productos Naturales/ MildredGarcía González, editor: Armando Cáceres. -1.ed.- San José, C. R. : Editorial de laUniversidad de Costa Rica: CYTED, 2000. 396p.8. Regulation on Tradicional Medicine: European Experience. Hubertus Cranz. CYTED.Memoir of Section VI. Standardización, Quality Control and Registration of HerbalMedicinal Products. Pág 79. I Grupo de Trabajo EAMIPreparados a base de Plantas Medicinales. Fitofármacos.10. Working Group on the Safety and Efficacy of Herbal Medicine. Repert series No.:RS/92/GE/15 (PHL).11. Draft Guideline on the format and content of applications for designation as orphanmedicinal products, revision 18/4/00.12. Final proposals for Revision of the Note for Guidance on Quality of Herbal Remedies.Emea. 1998.
13. Proposal for a Note for Guidance on Non-clinical Testing of Herbal Drug Preparationswith Long-term Marketing Experience-Guidance to Facilitate Mutual Recognition andUse of Bibliographic Data. Emea 1999.14. Final Comments for Revision of Notice to Applicants Volume 2ª part 1.4.2.Bibliographical Applications. Emea 1999.15. Guidelines for the assessment of herbal medicines, (aprobado en la VI ICDRA)Realizada en Otawa, 1991.16. Quality control methods for medicinal plant materials (WHO/PHARM/92.559).17. Good manufactoring practices for pharmaceutical products. Suppementary guidelinesfor the manufacture of herbal medicinal products (WHO/PHARM/93.561).18. Regulatory situation of Herbal Medicine: A world review (WHO/TRM/98.1).
Page 1 and 2: REPÚBLICA DE CUBAMINISTERIO DE SAL
Page 3 and 4: Estudios de utilización de medicam
Page 5 and 6: Producto terminado: Producto que ha
Page 7 and 8: PARTE I INFORMACIÓN ADMINISTRATIVA
Page 9 and 10: Ejemplo:a) Si no se pueden cuantifi
Page 11 and 12: (a) Características organoléptica
Page 13: dar lugar a efectos adversos. Se ad
Page 17 and 18: ANEXO 2. Modelo de solicitud de tr
Page 19 and 20: SOLICITUD DE TRAMITE DE AUTORIZACI
Page 21: ANEXO 4 Aspectos a contemplar en el

Regulación 29/02 - Cecmed - Infomed

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