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5th revised edition.
This document provides a ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use. The current revision took place at the seventh meeting of the AGISAR held in Raleigh, United States of America in 2016.
Application of a One Health approach .
The present guidance was developed with the support of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) to assist countries and other stakeholders in the establishment and development of programmes of integrated surveillan
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e document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
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Procedures Manual - Medicines registration in Madagascar - 2016 version
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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.
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.
Doc. No.: INS/GDL/001-(Annexes)
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
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s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Guidance for the preparation and submission of dossiers
