Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Anti Tuberculosis Medicines

Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Anti Tuberculosis MedicinesManufacturers Of Anti Tb MedicineThe 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 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 Tuberculosis The Medicines Listed In This Invitation Have BeenIdentified By The Expert Working Group For Medical Product Dossier Evaluation AndRegistration Of The Wa Mrh Project As Vital To Effective Treatment Of Tuberculosis BasedOn WahoS Assessment Of The Priority Health Needs In The Region And WhoS Evidencedbased Treatment Guidelines Single Ingredient First Line Anti Tuberculosis MedicinesO Ethambutol Hydrochloride E Coated Tablet Capsule 200Mg 275MgO Ethambutol Hydrochloride Coated Tablet Scored Capsule 400 MgO Isoniazid Tablet Capsule 300 MgO Pyrazinamide Z Coated Tablet Capsule 250MgO Pyrazinamide Tablet Capsule 400 Mg 500 MgO Rifampicin Capsule 150 Mg 300 MgO Rifabutin Capsule 150 MgO Rifapentine Tablet 150 Mg 300 MgO Streptomycin Powder For Injection 1G Vial 3O Streptomycin Powder For Injection 0 75 G Vial 3Footnote 3 With Or Without Diluent Water For Injection 5 Ml Vial Fixed Dose Combination Products Of First Line Anti Tuberculosis MedicinesO Isoniazid Rifampicin Coated Tablet Capsule 75 Mg 150 Mg Coated Tablet Capsule 150 Mg 150 Mg Coated Tablet Capsule 150 300 MgO Ethambutol Hydrochloride Isoniazid Coated Tablet Capsule 400 Mg 150 MgO Ethambutol Hydrochloride Isoniazid Rifampicin Coated Tablet Capsule 275 Mg 75 Mg 150 MgO Isoniazid Pyrazinamide Rifampicin Coated Tablet Capsule 150 Mg 500 Mg 150 MgO Ethambutol Hydrochloride Isoniazid Pyrazinamide Rifampicin Coated Tablet 275 Mg 75 Mg 400 Mg 150 Mg Single Ingredient Second Line Anti Tuberculosis MedicinesO Amikacin Solution Injection 500 Mg 2 Ml Vial Amp Powder For Injection 1G Vial 3O Bedaquiline Fumarate Tablet 100 MgO Capreomycin Powder For Injection 1G Vial3O Capreomycin Powder For Injection 500 Mg Vial3O Clofazimine Capsule 50 Mg And 100 Mg Tablet 100 Mg Scored O Cycloserine Capsule 250 MgO Delamanid Tablet 50 MgO Ethionamide Tablet Capsule 125Mg 250 Mg Scored O Gatifloxacin Tablet 200 Mg 400 Mg Scored O Kanamycin Solution For Injection 1 G Powder For Injection 1G Vial3O Kanamycin Solution For Injection 500 Mg Powder For Injection 500 Mg Vial3O Levofloxacin Tablet Capsule 250 Mg Tablet 500 Mg Scored Tablet 750 MgO Linezolid Coated Tablet 600 Mg Scored O Linezolid Oral Powder For Suspension 20 Mg Ml 240 Ml Bottle O Moxifloxacin Tablet Scored Capsule 400 MgO Prothionamide Tablet Capsule 250 MgO Para Aminosalicylic Acid Pas Sachets 4 G GranulesO Pas Sodium 100 G Jar Granules 4G 9 2 G Sachets Granules Powder For OralSolution SachetsO Terizidone Tablet Capsule 250 Mg 300 Mg 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 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

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