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Guidelines on Drug Registration Applications in Botswana

Drugs Advisory Board, Republic of Botswana (Gabarone, Botswana) (2000)
First Revised Edition March 2000
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Registration Guidelines for Medical Devices Bangladesh 2015

Directorate General of Drug Administration,, Ministry of Health and Family Welfare, People's Republic of Bangladesh (2015) C1
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Guidelines for Registration of Medicines and Health Products in Liberia

Liberia Medicines and Health Products Regulatory Authority (LMHRA) (2012) C1
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Rapid Evaluation of the Medicines Registration System in Benin

Diadié Maïga, Bedel Evi, Angélique Gbaguidi USAID, SIAPS (2016) C_WHO
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre... more
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Guidelines for the appropriate use of herbal medicines

World Health Organization (WHO), Regional Office for the Western Pacific (1998) C_WHO
WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o... more
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Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES

Government of Rwanda (2017) C2
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
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Rwanda: MOH GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Ministry of Health, Rwanda (2014) C2
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M... more
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A Guide to the Registration, Licensing and Scheduling of Medicinal Products in Malawi

Pharmacy, Medicines and Poisons Board, Malawi (2002) C2
First edition, November 1997 | Revised July 2002
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Medicine's registration procedure in Madagascar

Ministry of Health, Madagascar (2016) C1
Procedures Manual - Medicines registration in Madagascar - 2016 version
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Sierra Leone: GUIDELINES FOR MEDICINAL PRODUCT REGISTRATION

Pharmacy Board of Sierra Leone (PBSR) (2015) C2
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Namibia: Application for Registration of a Medicine

Ministry of Health and Social Services (MOHSS) (2014) C2
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
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Uganda: THE NATIONAL DRUG POLICY AND AUTHORITY (REGISTRATION) REGULATIONS, 2014

The Government of Uganda The Uganda Gazette (2014) C2
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 29.
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South Africa: GUIDELINES FOR THE REGISTRATION OF MEDICINES

Medicines Control Council (MCC), Department of Health Republic of South Africa (2012) C1
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
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Zambia: GENERAL GUIDELINES FOR SUBMITTING APPLICATIONS FOR REGISTRATION OF A MEDICINE

Zambia Medicines Regulatory Authority (ZAMRA) (2016) C2
First Edition
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Tanzania: GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Tanzania Food & Drugs Authority (TFDA) (2015) C2
First Edition
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GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF A MULTISOURCE (GENERIC) FINISHED PHARMACEUTICAL PRODUCT (FPP): QUALITY PART IN THE COMMON TECHNICAL DOCUMENT (CTD) FORMAT

Medicines Control Authority of Zimbabwe (MCAZ) (2012) C2
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GUIDELINES ON DRUG REGISTRATION APPLICATIONS IN BOTSWANA, 4th edition

Ministry of Health, Gabarone, Botswana (2014)
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Tutorial of local production of alcohol-based solution (WHO formulation)

WHO Collaborating Centre of Patient Safety Infection Control & Improving Practices; Hôpitaux Universitaires de Genève (HUG); Pharm-Ed WHO Collaborating Centre of Patient Safety Infection Control & Improving Practices; Hôpitaux Universitaires de Genève (HUG); Pharm-Ed (2016) C2
14.04.2016 Pharm -Ed -- The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man... more
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Diagnostic test for lymphatic filariasis to support decisions for stopping triple-therapy mass drug administration: target product profile

World Health Organization WHO (2021) C_WHO
TARGET PRODUCT PROFILE
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Target product profiles for animal plasma-derived antivenoms: antivenoms for treatment of snakebite envenoming in sub-Saharan Africa

World Health Organisation (WHO) (2023) C_WHO
This publication describes the first WHO public-benefit Target Product Profiles (TPPs) for snakebite antivenoms. It focuses on antivenoms for treatment of snakebite envenoming in sub-Saharan Africa. Four TPPs are described in the document: Broad spectrum Pan-African polyvalent antivenoms: products ... more