Community pharmacists are the health professionals most accessible to the public and are a cornerstone of primary health care. The role of community pharmacists is expanding globally. This report provides an overview of existing components and provisions of the legal and regulatory framework for com...munity pharmacies and their activities in Europe. It presents the diverse approaches to community pharmacy licenses and to establishment of new pharmacies and their ownership. It also details the framework for community pharmacy operating requirements (including opening hours, workforce, premises and equipment, services provided and identification of a community pharmacy) and the types of activity undertaken. Provisions associated with possible alternative forms of dispensing medicines (over-the-counter medicines, prescription-only medicines, dispensing by medical doctors and online medicine sales) are also described
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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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GOVERNMENT NOTICE | No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament
First Revised Edition
March 2000
Guidance for the preparation and submission of dossiers
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
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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Master of Science in Pharmaceutical Management Dissertation
Emergence of antimicrobial resistance is a result of the use, overuse and misuse of antibiotics both in humans and animals. In Ethiopia, there are indications on the misuse of antibiotics by health care providers’, unskilled practitioners, and drug consumers. These coupled with rapid spread of res...istant bacteria and inadequate surveillance contributed to the problem. Bacterial infections are the major causes of death in Ethiopia. Studies on antibacterial resistance and on bacterial infections have shown that emerging antibacterial resistance threatens the management of bacterial infections; however, the prevention and containment has received far too little attention.
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