DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
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.
The pharmaceutical sector of any nation is responsible for providing society with quality medicines and other pharmaceutical services. According to the World Health Organization (WHO), Pharmaceuticals may constitute as much as 40% of the national health budget in developing countries, yet portions o...f the population may lack access to the most essential medicines; while the limited funds available for health are spent on unnecessary, ineffective and even dangerous medications.
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This survey is part of a series of eight country surveys conducted in the context of the People that Deliver Initiative (peoplethatdeliver.org). This global initiative, which brings together the world’s largest organizations, aims to improve health services performance through the professionalizat...ion of logistics managers.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
Medicinal plants occupied an important position in the socio-cultural, spiritual and medicinal arena of rural people of India. T
The present report is based on contribution made by members of the task force and many other experts on medicinal plants. We hope the report on implementation will promot...e sustainable and equitable development of medicinal plants sector provide "Health for All", boost exports, and will improve livelihood of the people and green the country for the present and the
generation to come.
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This article examines the activities of national and international actors in Pharmaceutical Services (PS) in Mozambique from 2007 to 2012, focusing on the public provision of HIV/Aids, malaria and tuberculosis medicines. It describes how PS functions in the country, what actors are involved in this ...area and the relations among them, pursuing salient issues in the modus operandi of partners in cooperation.
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El Ministerio de Salud de Chile, atendida la relevancia de los medicamentos dentro del sistema de salud público y privado, ha planteado en la Política Nacional de Medicamentos (Res. Ex. MINSAL Nº 512/2004) los lineamientos y directrices bajo las cuales se deberá desarrollar la actividad nacional... en materia farmacéutica y dentro de éstos de encuentran las líneas de acción respecto de la Racionalidad en el Uso
de Medicamentos, que estructuran una serie de actividades destinadas a lograr un uso racional de los mismos.
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This guide helps pharmacists to understand their role in the hypertension program. From maintaining hypertensive drug stock, to drug dispensing, to recording and reporting, to awareness generation with patients.