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Diagnostic test for surveillance of lymphatic filariasis: target product profile

World Health Organization WHO (2021) C_WHO
The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test is needed for the detection of analyte(s) specific t... more
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Best Practice Guidelines: Effective Skin and Wound Management of Non-Complex Burns

Wounds International (2014) CC
This document is a practical guide to the management of burn injuries for healthcare professionals everyhwere who are non-burn specialistsi
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WHO Prequalification of Diagnostics Programme - Public Report (Product: ABONtm HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device, Number: PQDx 0141-051-00)

World Health Organization (2017) C_WHO
PQDx 0141-051-00 WHO PQDx Public Report April/2017, version 5.0
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: DPP® HIV 1/2 Assay, WHO reference number: PQDx 0053-006-00)

World Health Organization (2016) C_WHO
PQDx 0053-006-00 WHO PQ Public Report June/2016, version 2.0
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ASHP Guidelines on Pharmacy-Prepared Ophthalmic Products

American Society of Hospital Pharmacists (ASHP) ASHP (2008) CC
Drug Distribution and Control: Preparation and Handling–Guidelines Review 2008
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Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES

Government of Rwanda (2017) C2
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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Liquid Dosage Forms Extemporaneously Prepared from Commercially Available Products – Considering New Evidence on Stability

Haywood, A. and B. D Glass J Pharm Pharm Sci (2013) CC
J Pharm Pharm Sci (www.cspsCanada.org) 16(3) 441 - 455, 2013
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WHO Prequalification of Diagnostics Programme -Public Report (Product: BD FACSPrestoTM Near-Patient CD4 Counter System, PQ number: PQDx 0197-045-00)

World Health Organization (2016) C_WHO
PQDx 0197-045-00 WHO PQDx PR March /2016, version 2.0
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: OraQuick HIV 1/2 Rapid Antibody Test, WHO reference number: PQDx 0159-055-00)

World Health Organization (2017) C_WHO
PQDx 0159-055-00 WHO PQ Public Report February/2017, version 5.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: First Response® HIV 1-2-0 Card Test, Number: PQDx 0018-010-00)

World Health Organization (2016) C_WHO
PQDx 0018-010-00 WHO PQDx PR July/2016, version 3.0
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Tanzania: GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Tanzania Food & Drugs Authority (TFDA) (2015) C2
First Edition
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Rwanda: GUIDELINES ON VARIATIONS TO A REGISTERED PHARMACEUTICAL PRODUCT

Ministry of Health, Rwanda (2015) C2
Rwanda Guidelines for variation to registered pharmaceutical products.
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Uganda: Guidelines on good manufacturing practice for medicinal products - Part 1

National Drug Authority (NDA), Uganda (2017) C2
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: GeeniusTM HIV 1/2 Confirmatory Assay with GeeniusTM HIV 1/2 Confirmatory Controls, WHO reference number: PQDx 0181-031-00)

World Health Organization (2017) C_WHO
PQDx 0181-031-00 WHO PQ Public Report March/2017, version 3.0
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Rwanda: MOH GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Ministry of Health, Rwanda (2014) C2
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... more
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GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF A MULTISOURCE (GENERIC) FINISHED PHARMACEUTICAL PRODUCT (FPP): QUALITY PART IN THE COMMON TECHNICAL DOCUMENT (CTD) FORMAT

Medicines Control Authority of Zimbabwe (MCAZ) (2012) C2
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Safety and quality of water use and reuse in the production and processing of dairy products: meeting report

World Health Organisation (WHO) (2023) C_WHO
At its 48th session of Codex Committee on Food Hygiene (CCFH), the Committee noted the importance of water quality and safety in food production and processing. CCFH requested the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to provide guidan... more
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Nigeria: National Quality Assurance Policy For Medicines and Other Health Products

Federal Ministry of Health, Nigeria (2015) C1
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Recommendations of the German Central Committee against Tuberculosis (DZK) and the German Respiratory Society (DGP) for the Diagnosis and Treatment of Non-tuberculous Mycobacterioses

N. Schoenfeld, W. Haas, E. Richter, et al. (2016) C2
Empfehlungen zur Diagnostik und Therapie nichttuberkulöser Mykobakteriosen des Deutschen Zentralkomitees zur Bekämpfung der Tuberkulose (DZK) und der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin (DGP). Schönfeld N et al. Recommendations of the German Central Committee… Pneumolo... more
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Specifications for Essential Diagnostic Supplies

Ministry of Health, Kenya Ministry of health (2020) C1
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 review of the UHC pilot in September 2019 es... more