Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Reproductive Health

Expression Of Interest Are Invited For Regional Joint Medical Products Evaluation For Reproductive Health Manufacturers For Reproductive HealthIntroductionThe 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 Is Dated July 2019 And Is Available On Waho Website Www Wahooas Org Under The Section Resources Sub Section Publications And Research Sub Sub Section Essential Medicines 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 Reproductive Health The Medicines Listed In This Invitation HaveBeen Identified By The Expert Working Group For Medical Product Dossier Evaluation AndRegistration Of The Wa Mrh Project As Vital To Effective Treatment Of Reproductive Health Based On WahoS Assessment Of The Priority Health Needs In The Region And WhoSEvidenced Based Treatment Guidelines Oral Hormonal ContraceptivesO Ethinylestradiol Desogestrel Tablet 30 Micrograms 150 MicrogramsO Ethinylestradiol Levonorgestrel Tablet 30 Micrograms 150 MicrogramsO Levonorgestrel Tablet 750 Micrograms Pack Of Two 1 5 Mg Pack Of One O Norethisterone Tablet 350 MicrogramsO Norgestrel Tablet 75 MicrogramsO Desogestrel Tablet 75 MicrogramsO Ulipristal Acetate Tablet 30 MgInjectable Hormonal ContraceptivesO Medroxyprogesterone Acetate Depot Injection 150 Mg Ml In 1 Ml VialO Medroxyprogesterone Acetate Estradiol Cypionate Injection 25 Mg 5 MgO Norethisterone Enanthate Injection 200 MgO Norethisterone Enanthate Estradiol Valerate Injection 50 Mg 5 MgO Depot Medroxyprogesterone Acetate Dmpa Sc Subcutaneously AdministeredInjectionO 104 Mg 0 65 MlImplantable ContraceptivesO Levonorgestrel Two Rod Hormone Releasing Implant Each Rod Containing 75 MgO 150 Mg In Total O Etonogestrel Implant 68 Mg Of EtonogestrelHormonal Intra Uterine DeviceO Levonorgestrel Intra Uterine System Intrauterine System With Reservoir Containing52 Mg Of Levonorgestrel Intravaginal ContraceptivesO Progesterone Vaginal Ring Progesterone Releasing Vaginal Ring Containing 2 074G Of Micronized Progesterone Utero TonicsO Misoprostol 25 Microgram Tablet 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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