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This standard operating procedure (SOP) describes the procedures to be used by the members of Pharmacovigilance Department of National Medicines and Healthcare Products Regulatory Authority (NMHRA), Medicine Safety Committee (MSC) and by health care professionals for the recording, management and reporting of suspected adverse drug reactions (ADRs) and other suspected adverse events (AEs) that are

These guidelines are intended to ensure that medicines marketed in Afghanistan are safe, efficacious, and of good quality; assist applicants with the preparation of applications for the registration of multisource (generic) products by providing clear general guidance on the format of the dossiers; provide guidance on technical and other general data requirements.

Prior to the efforts of the MoPH supported by the USAID Strengthening Pharmaceutical Systems Project (SPS) in September 2010, no comprehensive information existed regarding the density and distribution of pharmaceutical personnel providing pharmaceutical services, their competencies, and human resources issues.

The Afghanistan National Medicines Policy (NMP) 2014-2019 is the overall policy document for the Afghanistan pharmaceutical sector to ensure the safety and safe use of high-quality drugs, vaccines, medical equipment, and complementary medicines for all people in Afghanistan.

The CPDS roadmap is a plan to coordinate MOPH, several donors, nongovernmental organizations (NGOs), United Nations agencies, and other multi- and bilateral agencies for procuring and distributing medicines and medical supplies to facilities offering BPHS and EPHS.

Given the quick development and expansion of the health service delivery system in Afghanistan since 2003, the need for updating the EML became urgent.

Given the quick development and expansion of the health service delivery system in Afghanistan since 2003, the need for updating the EML became urgent.

Stakeholder communication is necessary for better coordination and control of pharmaceutical supply management (PSM) activities.

To address the lack of pharmaceutical supply information, a Data and Information Committee (DIC) of the CPDS was established and tasked to develop a Pharmaceutical Logistics Information System (PLIS) to gather the information about pharmaceutical procurement, distribution and consumption in the BPHS/EPHS implementers and health facilities.

The main objective of the survey was to set a baseline for the specific conditions that are intended for improvement through the implementation of revised registration guidelines and procedures, or that SPS Afghanistan interventions are targeting for change.

In 2012, the Strengthening Pharmaceutical Systems (SPS) Afghanistan Associate Award project—in collaboration with the General Directorate of Pharmaceutical Affairs (GDPA), Grants Contracts Management Unit (GCMU), and nongovernmental organizations (NGOs) implementing Partnership Contracts for Health (PCH)—undertook a detailed analysis of outpatient conditions and treatment in a sample o

Afghanistan’s National Medicine and Healthcare Products Regulatory Authority (NMHRA) uses its Private Pharmacy Outlet Registration (PPOR) database to capture and report on information about private retail pharmacies that are registered with the NMHRA. NMHRA uses the reported information to monitor pharmacies’ registration status or updates, to facilitate coordination among NMHRA d

With technical and financial assistance from SPS, GIHS reviewed and updated/developed its pharmacy assistant curriculum from 2012 to 2015. The final syllabus and curriculum for 21 subjects were printed (500 copies) in high-quality color format and then disseminated through orientation workshops.

This is the overall policy document for Narcotic and Controlled Medicines of Afghanistan pharmaceutical sector. This policy constitutes part of continuous efforts by the Ministry of Public Health (MoPH) and the stakeholders to ensure accessibility to and prevention of abuse of narcotic and controlled medicines.

To ensure that the inspection of pharmaceutical importers is carried out with good standards, MOPH initiated the development of the pharmaceutical importers inspection checklist to guide the inspectors.

To ensure that the inspection of retail pharmacies is carried out with good standard, MOPH initiated the development of the retail pharmacies inspection checklist to guide the inspectors.

To ensure that the inspection of pharmaceutical wholesalers is carried out with good standard, MOPH initiated the development of the wholesalers’ inspection checklist to guide the inspectors.

To ensure that the inspection of pharmaceutical importers is carried out with good standards, MOPH initiated the development of the pharmaceutical importers inspection checklist user manual.

To ensure that the inspection of retail pharmacies is carried out with good standards, MOPH initiated the development of a user manual for the retail pharmacies inspection checklist.

To ensure that the inspection of wholesalers is carried out with good standards, MOPH initiated the development of a user manual for the wholesalers’ inspection checklist.

This is the overall policy document for Waste Management and Safe Disposal of Pharmaceutical system for Afghanistan’s pharmaceutical sector. The goal of this document is to provide a comprehensive waste disposal system for medicines so as to ensure their safe destruction in a cost-effective and efficient manner; and to do this whilst also providing full protection of the environment.

This document is the overall policy for the product quality assurance (QA) system for Afghanistan’s pharmaceutical sector. This policy, the National Pharmaceutical Quality Assurance Policy, is part of continuous efforts by the Ministry of Public Health (MoPH) and stakeholders to ensure the safety, efficaciousness, and quality of medicines.

This framework seeks to outline a national strategy for the development of pharmaceutical HR in the public and private sectors in Afghanistan to produce a stronger pharmaceutical system that responds to the population’s needs. In particular, the framework serves as a reference document for the Human Resources for Health plan and the HR section of the National Medicines Policy of the MoPH.

This document aims to present a concept for the establishment of an independent NMHRA in the country, through which the regulatory activities of various MoPH authorities are coordinated and incorporated so that it is ensured that medical products are of a better quality and that the medicines consumed in the country are safe.

The National Medicine Board was established in 2003 and then it was promoted to the National Medicines & Food Board (NMFB) in 2009. According to the Medicine Law (2008), the Board is the highest decision making entity on issues related to pharmaceuticals. Upon its expansion in 2009, the Board’s mandate was extended to include foodstuff.

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