Expression of interest For Regional Joint Medical Products Evaluation For Neglected Tropical Disease

Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Neglected Tropical Disease Manufacturers For NtdMedicinal Products For This EoiThe Aim Of This Eoi Is To Evaluate A Specific Range Of Medical Products Available In RelationTo The Management Of Neglected Tropical Disease The Medicines Listed In This InvitationHave Been Identified By The Expert Working Group For Medical Product Dossier EvaluationAnd Registration Of The Wa Mrh Project As Vital To Effective Treatment Of NeglectedTropical Disease Based On WahoS Assessment Of The Priority Health Needs In The Region And WhoS Evidenced Based Treatment Guidelines List Of MedicinesO Diethylcarbamazine Citrate 100Mg Tablet Scored O Praziquantel 600Mg Tablet Scored O Ivermectin 3Mg Tablet Unscored O Miltefosine 10Mg And 50Mg CapsuleO Sodium Stibogluconate 10 SbO 100Mg Ml 30Ml Or 100Ml Vial Injectable O Paromomycin Solution For Intramuscular Injection Of Paromomycin Base As TheSulfate 375Mg Ml 2Ml Ampoule How To Submit An EoiThe 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 Fda Head Office 17 Indian Ocean Street Off Nelson Mandela Avenue SouthLegon Commercial Area Shiashie Accra Ghana Telephone 233554456478 3 The Applicant Should Provide Samples Of The Medical Product And ReferenceSubstances The Sample Size Shall Be In Line With The Quantity Defined By The Ewg ForQuality Control And Published Under The Essential Medicines And Vaccines SectionOn The Waho Website The Samples Should Be Submitted Together With The DossiersTo The Lead Coordinating Nmra Fda Ghana 4 After Screening A Certificate Of Eligibility Or Non Eligibility For Full Evaluation Will Be SentTo The Applicant By The Lead Coordinating Nmra On Receipt Of A Certificate Of EligibilityThe Applicant Should Pay The Full Evaluation Fee Within 30 Calendar Days To The Wamrh Secretariat Bank Account Specified In The Certificate The Applicable Fee For TheProcessing Of The Application A Certificate Of Eligibility Applicants In The West Africa Region Will Pay Us 8 000 Applicants In Other Regions Of Africa Will Pay Us 10 000 Applicants Outside Africa Will Pay Us 12 000

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