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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Compilation of country case studies and best practices. World Health Report (2010) Background Paper, 25
This document provides guidance on the application of non-pharmaceutical countermeasures to minimise the spread of the 2019 novel coronavirus (2019-nCoV) in the population. Some of the measures proposed refer specifically to certain phases of the epidemic (containment or mitigation phases), and can ...be adapted depending on the assessed severity/impact of the infection. Other measures are valid for all phases of an epidemic.
The guidance is based on the current knowledge of the 2019-nCoV and evidence available on other viral respiratory pathogens, mainly the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV), the Middle East Respiratory Syndrome-related coronavirus (MERS-CoV) and seasonal or pandemic influenza viruses.
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Bull World Health Organ 2017;95:594–598
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alon...gside the standards for registered pharmacies. These aim to create and maintain the right
environment, both organizational and physical, for the safe and effective practice of pharmacy.
By following this guidance, the pharmacy will:
• demonstrate that it meets our standards, and
• provide assurances that the health, safetyand wellbeing of patients and the public are safeguarded
Responsibility for making sure this guidance is followed lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body
corporate’, the directors have responsibility.
Those responsible for the overall safe running of the pharmacy need to take into account the nature of the pharmacy and the range of services
already provided and, most importantly, the needs of patients and members of the public.
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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
Examination of the business behaviour of Boehringer Ingelheim, Bayer and Baxter in Uganda
The International Pharmaceutical Federation (FIP) is a global federation of national associations of pharmacists and
pharmaceutical scientists. In order to support these associations in their fight against AMR, FIP has prepared this
briefing document. It is an overview of the different activities ...that community and hospital pharmacists are involved
into prevent AMR and to reverse AMR rates.
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Recommendations for step-wise implementation
The purpose of this document is to provide relevant information and guidelines on
coronavirus outbreaks – and in particular the novel coronavirus SARS-CoV-2 and the
diseases it produces, COVID-19 – for pharmacists and the pharmacy workforce, both in a
primary care context (i.e. community phar...macies and primary healthcare facilities) and in
hospital settings, as well as for pharmacists working as clinical biologists in medical
analysis laboratories, for example, as clinical biologists, and offer a set of references that
may be consulted for more informationstor
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