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 on the safety, quality and efficacy of medicines.
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...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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Accessed: 21.03.2019
mhGAP Training Manual for the mhGAP Intervention Guide for mental, neurological and substance use disorders in non-specialized health settings – version 2.0 (for field testing)
Manual for use in primary care
Int J Health Policy Manag 2017, 6(10), 587–600
Low-income countries face many contextual challenges to manage healthcare technologies effectively, as the majority are imported and resources are constrained to a greater extent. Previous healthcare technology management (HTM) policies in Benin ha...ve failed to produce better quality of care for the population and cost-effectiveness for the government. This study aims to identify and assess the main problems facing HTM in Benin’s public health sector, as well as the ability of key actors within the sector to address these problems.
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This Pharmaceutical Country Profile for Kenya (2010) has been developed by the Ministry of Medical Services with support of the World Health Organization. The Profile contains information on existing socio-economic and health-related conditions, resources, regulatory structures and processes and out...comes relating to the pharmaceutical sector in Kenya.
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This report reviews and analyses the Affordable Medicines Programme, which was introduced in Ukraine in April 2017 to provide patients with improved access to 23 outpatient medicines for the treatment of chronic noncommunicable diseases. The evaluation combines both quantitative and qualitative anal...ysis. The findings confirm that the Programme has contributed to a significant increase in access to needed outpatient medicines in Ukraine. Further, while implementation was successful overall, uptake across regions was uneven. The report concludes by listing a number of policy options to support the sustainability and expansion of the Affordable Medicines Programme.
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El grupo de Farmacovigilancia de la red Panamericana para la Armonización Farmacéutica (PARF) de la Organización Panamericana de la Salud (OPS), ha desarrollado este documento desde la visión OPS/OMS, considerando que la farmacovigilancia es un componente esencial de los programas de salud públ...ica. Se trabajó con el objetivo de facilitar el desarrollo, mejorar y fortalecer los sistemas de
farmacovigilancia en la región de las Américas y promover el ejercicio de las buenas prácticas para mejorar la seguridad del paciente y de la población de acuerdo a las necesidades de la región.
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Guía de medicamentos esenciales para primer nivel de atención – Edición 2019
Objetivo: Describir el perfil de sensibilidad y resistencia antimicrobiana de las bacterias “ESKAPE” aisladas en todas las unidades de internación del Hospital Del Norte durante la gestión 2019.
Este manual pretende estandarizar la práctica del SFT para que el QF pueda trabajar
con los usuarios de forma consistente y estandarizada a nivel nacional.