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.
more
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
Compilation of country case studies and best practices. World Health Report (2010) Background Paper, 25
Infection prevention and control (IPC) practices are of critical importance in protecting the function of healthcare services at all levels and mitigating the impact on vulnerable populations. Although the management of possible COVID-19 cases is usually guided by national policies for specific heal...thcare facilities, community transmission is currently widespread in most EU/EEA countries and the UK, therefore primary healthcare providers in the community such as GPs, dentists and pharmacists are at risk of being exposed to COVID-19.
more
The Pharmaceutical Forum of the Americas (PFA) has previously published guidelines and organised campaigns for community pharmacists on the prevention, detection and control of arbovirus infections in 2018 with a grant from the FIP Foundation for Pharmacy Education and Research. Building on that exp...ertise, FIP joined efforts with the PFA and is now publishing its first-ever handbook to support pharmacists in the
area of vector-borne diseases. As the integration of the regional forums in FIP advances, such collaborative projects are tangible results of an increasingly regionally informed and regionally targeted work by FIP.
more
This module will consider the role of community pharmacy teams in tackling antimicrobial resistance. After reading this module you will be able to explain why antimicrobial resistance is a threat to patient safety, and public and global health. You will also be able to list common self-limiting infe...ctions, their usual duration, and outline the key messages that you should be sharing with the public.
more
After completing this activity, pharmacists should be able to:
1. List populations for which the compounding of an oral liquid may be necessary
2. Outline necessary considerations that should be made by the pharmacist to ensure product stability
3. Describe methods used in the compounding of liqu...id preparations
more
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.
more
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.