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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This course is based on the Manual on Safety in Administering Medicines for Neglected Tropical Diseases which provides practical tools, training modules and jobs aids to further improve the planning, preparation, and monitoring of safe administration of NTD medicines.
The manual is written for clinicians working at the district hospital (first-level referral care) who diagnose and manage sick adolescents and adults in resource constrained settings. It aims to support clinical reasoning, and to provide an effective clinical approach and protocols for the managemen...t of common and serious or potentially life-threatening conditions at district hospitals. The target audience thus includes doctors, clinical officers, health officers, and senior nurse practitioners. It has been designed to be applicable in both high and low HIV prevalence settings.
Volume 2 provides a symptom-based approach to clinical care for acute and subacute conditions (including mental health). It provides short summaries of the management of diseases that affect multiple systems of the body, focusing on communicable diseases. It also includes the chronic or long-term management of HIV, TB, alcohol, and substance use disorders.
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Resources for the Prevention and Treatment of Substance Use Disorders (SUD)
MICS surveys measure key indicators that allow countries to generate data for use in
policies and programmes, and to monitor progress towards the Millennium Development Goals (MDGs) and
other internationally agreed upon commitments.
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.