SHOPS and HIA finalized a scope of work with USAID Senegal in April 2015, and a team of five private sector experts conducted the onsite assessments between May and June 2015. The Private Sector Assessment (PSA) team worked closely with Senegalese key stakeholders throughout the process. The PSA tea...m interviewed more than120 individuals from approximately 78 organizations, including the government of Senegal (GOS), donors, USAID implementing partners, private sector umbrella organizations, private insurance companies, faith-based organizations (FBOs), nongovernmental organizations (NGOs), private health care facilities, and private pharmacies.
Through stakeholder interviews and review of government reports and online resources, the assessment team noted the following findings by theme.
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Official Gazette No Special of 17/01/2013 | LAW No 47/2012 OF 14/01/2013 RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
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 Medicine 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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WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availa...bility Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
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Essential Medicines and Health Products Information Portal
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 guide...lines 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.
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availa...bility Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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