Expression Of Interest For Manufacturers Of Medicinal Products For Malaria

Expression Of Interest For Manufacturers Of Medicinal Products For Malaria Call For Expression Of Interest Eoi For Regional Joint Medical Products Evaluation For Antimalaria MedicinesThe Invitation Is Published In Accordance With The Document Titled Wa Mrh RegionalJoint Medical Product Evaluation Procedure For Pharmaceutical Product Dossier Which IsDated July 2019 And Is Available On Waho Website Www Wahooas Org Under The SectionResources Sub Section Publications And Research Sub Sub Section EssentialMedicines And Vaccines Assessment Of Product S Submitted Under This Invitation Will Include Evaluation Of Product Dossiers Which Must Include Product Data And Information As Specified InThe Guidelines For Submission Manufacturing Sites Which Must Adhere To Good Manufacturing Practices Gmp Product Samples Which Must Adhere To The Requisite SpecificationsMedicinal Products For This EoiThe Aim Of This Eoi Is To Evaluate A Specific Range Of Medical Products Available In RelationTo The Management Of Malaria The Medicines Listed In This Invitation Have Been IdentifiedBy The Expert Working Group For Medical Product Dossier Evaluation And Registration OfThe Wa Mrh Project As Vital To Effective Treatment Of Malaria Based On WahoSAssessment Of The Priority Health Needs In The Region And WhoS Evidenced BasedTreatment Guidelines Artemisinin Based Fixed Dose Oral Combination Formulations Artemether LumefantrineO Tablet 20 Mg 120 MgO Tablet 40 Mg 240 MgO Tablet 60 Mg 360 MgO Tablet 80 Mg 480 Mg Artesunate AmodiaquineO Tablet 50 Mg 135 MgO Tablet 100 Mg 270 Mg Artesunate MefloquineO Tablet 100 Mg 200 Mg Artesunate PyronaridineO Tablet 60 Mg 180 Mg Dihydroartemisinin Piperaquine PhosphateO Tablet 40 Mg 320 MgO Tablet 60 Mg 480 MgO Tablet Scored 80 Mg 640 MgArtemisinin Based Fixed Dose Combination Oral Paediatric Formulations Preferably Dispersible Artemether Lumefantrine Tablet 20 Mg 120 Mg Artesunate Amodiaquine Tablet 25 Mg 67 5 Mg Artesunate Mefloquine Tablet 25 Mg 50 Mg Artesunate Pyronaridine Tablet 20 Mg 60 Mg Dihydroartemisinin Piperaquine Phosphate Tablet 20 Mg 160 Mg Scored Tablet30 Mg 240 Mg Tablet 40 Mg 320 MgArtemisinin Based Single Ingredient Formulations Artemether Oily Injection 20 Mg Ml 40 Mg Ml 80 Mg Ml 100 Mg Ml Artesunate Powder For Injection 30 Mg 60 Mg 120 Mg Vial Artesunate Suppositories 50 Mg 100 Mg 200Mg The Lead Coordinating Nmra For This Invitation For Eoi Is The Nmra Of Ghana The FoodAnd Drug Authority Http Www Fdaghana Gov Gh In Order To Submit An Expression Of Interest For Product Evaluation The Applicant Must DoThe Following 1 The Applicant Will Pay The Management Fees Of Us 500 For The Lead CoordinatingNmra Fda Ghana For Reception Screening File Management And CommunicationWhen Submitting The File The Bank Account Details Are As Follows Food And Drugs AuthorityBank Of GhanaAccount No 1018631529507Swift Code Baghghac 2 The Applicant Should Download And Complete The Market Authorization Application Ma File In Accordance With The Harmonized Common Technical Document Ctd Format On Waho Website Www Wahooas Org Under The Section Resources Subsection Publications And Research Sub Sub Section Essential Medicines AndVaccines The Completed Application Ma File Should Be Submitted Electronically ToThe Lead Coordinating Nmra Fda Fdaghana Gov Gh With A Hard Copy Sent To Room316 Fire Detection And Alarm Head Office 17 Indian Ocean Street Off Nelson Mandela Avenue SouthLegon Commercial Area Shiashie Accra Ghana Telephone 233554456478

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