Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Antimalaria Medicines Manufacturers Of Antibacterial MedicineMedicinal Products For This EoiThe Aim Of This Eoi Is To Evaluate A Specific Range Of Medical Products Available In RelationTo The Management Of Antibacterial Infections And Related Diseases The Medicines ListedIn This Invitation Have Been Identified By The Expert Working Group For Medical ProductDossier Evaluation And Registration Of The Wa Mrh Project As Vital To Effective TreatmentOf Antibacterial Infections And Related Diseases Based On WahoS Assessment Of ThePriority Health Needs In The Region And WhoS Evidenced Based Treatment Guidelines CephalosporinsO Cefepime Infusion 1G 50MlO Cefepime Infusion 2G 100MlO Cefepime Powder For Injection 500MgO Cefepime Powder For Injection 1GO Cefepime Powder For Injection 2GO Cefpirome Powder For Injection 1GO Cefpirome Powder For Injection 2GCarbapenemsO Imipenem Cilastatin Powder For Injection 250Mg 250MgO Imipenem Cilastin Powder For Injection 500Mg 500MgO Meropenem Powder For Injection 500MgO Meropenem Powder For Injection 1000MgHow 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 Fire Detection And Alarm 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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