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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected b
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
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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 Techni
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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
In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of p
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Rwanda Guidelines for variation to registered pharmaceutical products.
The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e.
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and
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This document on logistics management information systems (LMIS) was developed to address the increasing need for harmonization and standardization of core indicators for managing medicines and health products for neglected tropical diseases (NTDs)
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A user-friendly instrument designed to collect and calculate indicators of effective inventory management. The IMAT guides the user through a process of collecting data on the physical and theoretical stock balance and the duration of stockouts for a set of up to 25 frequently-used
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Antimicrobial resistance (AMR) is occurring everywhere in the world, compromising the ability to treat infectious diseases, as well as undermining many other advances in health and medicine. Underlying factors that drive AMR include; weak or absent surveillance and monitoring systems, inadequate sys
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This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and
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Pharmaceutical residues occur globally in the environment. This is demonstrated in the updated database “PHARMS-UBA”. Residues of pharmaceuticals in the environment have been measured in 89 countries in all UN regions. For Germany, 414 active su
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically
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August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a r
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