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Emergency Medicines List (EML). First Edition, November 2014 - Ethiopia

Food, Medicine and Health care Administration and Control Authority of Ethiopia (FMHACA) (2014) C_WHO
The list of emergency medicine has been developed though various consultative meeting and workshops with concerned health professionals and institutions. The medicines in the list should be administered to emergency patients only treated in the health institutions, purchased from legal medicine reta... more
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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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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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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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LAW RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS

Government of Rwanda (2013) C2
Official Gazette No Special of 17/01/2013 | LAW No 47/2012 OF 14/01/2013 RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS
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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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Zambia: THE MEDICINES AND ALLIED SUBSTANCES ACT, 2013

The Government of Zambia (2013) C1
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie... more
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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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Botswana: Medicines and Related Substances Act

Government of Botswana (2013) C1
A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
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Botswana: Guidelines for stability testing of pharmaceutical products

Ministry of Health, Gabarone, Botswana (2009) C2
This guideline is intended to provide requirements to applicants wishing to submit applications for registration of medicines in Botswana.
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Ethiopian Food and Drug Authority Website

Ethiopian Food and Drug Authority (2022) CC
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit... more