MODULE 2.3 QUALITY OVERALL SUMMARY: PRODUCT DOSSIER (QOS-PD) of documentation for a multisource (generic) finished See sections 1.5, 3 and 4 of “Guideline on submission pharmaceutical for general and detailed instructions on the completion of this product (FPP): quality part” template. INTRODUCTION Summary of product information: Non-proprietary name(s) of the finished pharmaceutical product(s) (FPP) Proprietary name(s) of the finished pharmaceutical product(s) (FPP) International non-proprietary name(s) of the active pharmaceutical ingredient(s) (API(s)), including form (salt, hydrate, polymorph) Applicant name and address Dosage form Reference Number(s) Strength(s) Route of administration Proposed indication(s) Title: Primary Contact person responsible for this First name: application Family Name: Contact person's job title Contact person's postal address Unit Building/PO Box number Road/Street Plant/Zone Village/suburb Town/City District and Mandal Province/State
MODULE 2.3 QUALITY OVERALL SUMMARY: PRODUCT DOSSIER (QOS-PD) See sections 1.5, 3 and 4 of “Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): quality part” for general and detailed instructions on the completion of this template. INTRODUCTION Summary of product information: Non-proprietary name(s) of the finished pharmaceutical product(s) (FPP) Proprietary name(s) of the finished pharmaceutical product(s) (FPP) International non-proprietary name(s) of the active pharmaceutical ingredient(s) (API(s)), including form (salt, hydrate, polymorph) Applicant name and address Dosage form Reference Number(s) Strength(s) Route of administration Proposed indication(s) Primary Contact person responsible for this application Title: First name: Family Name: Contact person's job title Contact person's postal address Unit Building/PO Box number Road/Street Plant/Zone Village/suburb Town/City District and Mandal Province/State
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