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Guidelines and Forms

KENYA

Kenya Variation Guideline version 2.4 1710

Kenya Guidelines for Clinical Trials Rev No.1 1609

Kenya- KEBS-PPB Public Notice 170606

Kenya Guideline for Inspection of Imported MD-FS-MC-HP-and-OB-Products 170606

Kenya Guidelines for the Registration of herbal and Complimentary Medici…

Kenya Application form for the Registration of Herbal and Complimentary …

Kenya PPB Variation Guidelines 160401

Kenya PPB Variation Application Form 160401

PPB Guideline for Registration of Medical Devices 1109xx

PPB Application for Listing of a Medical Device d160923

KAPI Code of Practice 1603

Form for Reporting Poor Quality Medicines d150814

Application Form for GMP Inspection d150814

Guidelines for registration of Human and Veterinary Medicines 10XXXX

CTD Application Form 10XXXX

Guidelines for Clinical Trials 14XXXX

Clinical Trial Application Form d150814

Checklist for Clinical Trials 120119

Template for Listing of a Medical Device d150814

Template for Listing of Food Supplements and Borderline Products d150814

Guidelines for Advertisement and Promotion of Medicines and Medical Devices 1204XX

Guidelines for Product Recall & Product Withdrawal 100413

ARCHIVED

Kenya variation guidelines Rev No.1 1704

Variation Application Forms

Variation Guideline 2013

Variation Guidelines 13XXXX

 

Last updated:Thursday, October 12, 2017
Information presented here is subject to change. Should you have additional inputs / insights to contribute please contact info@ipasa.co.za.
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The Regulatory Resources for Africa website has been made possible by a non-prescriptive grant by Innovative Pharmaceutical Association South Africa (IPASA). . The intention of the sponsors is to create a platform where up to date and useful information concerning the medicines regulatory environment in Africa, can be shared by all

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