Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Hiv Infections And Related Diseases

Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Hiv Infections And Related DiseasesManufacturers For Hiv IntroductionThe West Africa Medicines Regulation Harmonization Wa Mrh Project Has Agreed A Single Process For Regional Medical Product Evaluation To Enable The Registration Of Medicinal Products In The 15 Ecowas Member States This Call Is An Invitation To Manufacturers Of Anti Malaria Medicines To Submit Expressions Of Interest Eoi For The Regional Joint Medical Products Evaluation For Registration Under This Project The Invitation Is Published In Accordance With The Document Titled Wa Mrh Regional Joint 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 Specifications Medicinal Products For This EoiThe Aim Of This Eoi Is To Evaluate A Specific Range Of Medical Products Available In RelationTo The Management Of Hiv Infections And Related Diseases The Medicines Listed In ThisInvitation Have Been Identified By The Expert Working Group For Medical Product DossierEvaluation And Registration Of The Wa Mrh Project As Vital To Effective Treatment Of HivInfections And Related Diseases Based On WahoS Assessment Of The Priority HealthNeeds In The Region And WhoS Evidenced Based Treatment Guidelines Antiretrovirals As Single Ingredient Formulations For Use In Adults AndAdolescents Nucleoside Nucleotide Reverse Transcriptase Inhibitors O Lamivudine Tablet 300Mg Non Nucleoside Reverse Transcriptase Inhibitors O Efavirenz Tablet 400MgO Etravirine Tablet 200Mg Integrase Inhibitors O Dolutegravir Tablet 50Mg Preferably Scored And DispersibleO Raltegravir Tablet 400Mg Nucleoside Nucleotide Reverse Transcriptase Inhibitors Plus Nonnucleoside Reverse Transcriptase Inhibitors O Emtricitabine Tenofovir Disoproxil Fumarate Efavirenz Tablet200Mg 300Mg 400MgO Lamivudine Tenofovir Disoproxil Fumarate Efavirenz Tablet300Mg 300Mg 400MgO Lamivudine Tenofovir Disoproxil Fumarate Efavirenz Tablet300Mg 300Mg 600MgThe 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 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 And Vaccines The Completed Application Ma File Should Be Submitted Electronically To The Lead Coordinating Nmra Fda Fdaghana Gov Gh With A Hard Copy Sent To Room 316 Fire Detection And Alarm Head Office 17 Indian Ocean Street Off Nelson Mandela Avenue South Legon Commercial Area Shiashie Accra Ghana Telephone 233554456478 3 The Applicant Should Provide Samples Of The Medical Product And Reference Substances The Sample Size Shall Be In Line With The Quantity Defined By The Ewg For Quality Control And Published Under The Essential Medicines And Vaccines Section On The Waho Website The Samples Should Be Submitted Together With The Dossiers To The Lead Coordinating Nmra Fda Ghana 4 After Screening A Certificate Of Eligibility Or Non Eligibility For Full Evaluation Will Be Sent To The Applicant By The Lead Coordinating Nmra On Receipt Of A Certificate Of Eligibility The 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 The Processing 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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