Guidelines and Forms | RRFA

Guidelines and Forms

ZIMBABWE

Guidance On The Selection Of Comparator Products For Bioequivalence And Biopharmaceutics Classification System

Guidelines on the Import and Export of Registered Medicines

Guidelines for Advertising and Promotion of Medicines in Zimbabwe

EVRF 30 Rev 00_April 2017_APPLICANTS_SCREENING CHECKLIST FOR REGISTRATION OF HUMAN MEDICINES

Zimbabwe Form Product Defect 0911DD

Zimbabwe Form SAE Report 14MMDD

Zimbabwe Form AEFI Report 170711

Zimbabwe Guideline GCP 12MMDD

Zimbabwe 03 rev 01 march 2015 bioequivalence trial information form

Zimbabwe 05 rev 03 march 2015 biopharmaceutics classification system bcs based biowaiver information form

Zimbabwe 07 rev 02 march 2015 biowaiver for additional strength information form

Zimbabwe mc8_form

MCAZ guideline on biowavers rev1 aug 2009

MCAZ guideline on biowavers rev1 june 2009 appendix

MCAZ guideline on submission of documents for interchangeability rev 0 aug 2009

MCAZ-qis 20022012

MCAZ-qos 15122011

CTD guidelines March 2013

MCAZ amendment guidelines March 2010

form_evf07_biowaiver_application_form_additional_strength_rev1_aug_09

form_evf03__bioequivalence_application_form__rev1_aug_09

form_evf05_biowaiver_application_form_rev2_aug_09

Archived

Zimbabwe Guideline AE Following Immunization 13MMDD

Zimbabwe Guideline AE Following Immunization 1607DD

Last updated:Monday, September 17, 2018

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