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First Revised Edition
March 2000
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
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...
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutica...
First edition, November 1997 | Revised July 2002
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....
Procedures Manual - Medicines registration in Madagascar - 2016 version
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, imp...
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 f...
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 heal...
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 ma...
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 PRODU...
Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATE...
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective ... this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to strengthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
