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Threats posed by stockpiles of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective
Pakoyo Fadhiru Kamba, Munanura Edson Ireeta, Sulah Balikuna et al.
World Health Organisation (WHO)
(2017)
C_WHO
Bull World Health Organ 2017;95:594–598
NEMLIST | Sixth Edition | February 2016
Accessed November, 2017
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
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
...
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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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
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edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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