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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WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o...f herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade.
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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
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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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
First edition, November 1997 | Revised July 2002
Procedures Manual - Medicines registration in Madagascar - 2016 version
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 29.
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man...ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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Society first acknowledges a child’s existence and identity
through birth registration. The right to be recognized as
a person before the law is a critical step in ensuring
lifelong protection and is a prerequisite for exercising all
other rights. A birth certificate is proof of that legal ide...ntity, and is
the basis upon which children can establish a nationality,
avoid the risk of statelessness and seek protection from
violence and exploitation. For example, proof of age is
needed to help prevent child labour, child marriage and
underage recruitment into the armed forces. A birth
certificate may also be required to access social service
systems, including health, education and justice.
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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.