TYPE OF APPLICATION – HUMAN PRODUCT (Registration/Re-Registration) |
MODULE 1: ADMINISTRATIVE INFORMATION |
SECTION 1: PARTICULARS OF THE PRODUCT |
1.0 Name and address of Applicant |
1.1 | Type of the Medicinal product licence application |
| Type of the medicinal product application New/innovator GenericConditional Authorization Emergency Use Authorization Extension application Duplicate license Renewal/Re-registration** If variation has been made, information supporting the changes should be submitted. See variation guidelines for registered medicinal products. |
1.2 | Trade/Proprietary name (proprietary Product name): |
1.3 | Approved / generic name/Active PharmaceuticalIngredient: |
1.4 | Strength of the Active Pharmaceutical Ingredient (API) per unit dosage of the product andspecifications of the API: |
1.5 | Dosage form |
1.5.1 | Pharmaceutical Dosage form of the product: |
1.5.2 | Therapeutic Indication (s): |
1.5.2 | Route(s) of administration (use current list of standard terms - European Pharmacopoeia): |
1.6 | Packing/Pack size of the product: |
1.6.1 | Pack size: |
1.6.2 | Primary packing materials: |
1.6.3 | Secondary packing materials: |
1.7 | Visual Description of the product |
1.8 | Proposed/Approved Shelf life of the product (In months): |
1.9 | Pharmacotherapeutic group and ATC Code |
1.10 | Legal category |
1.11 | Country of origin or country of release: |
1.12 | Product Marketing Authorisation in the country of origin. (Attach certificate of pharmaceutical product from competent regulatory authority) |
1.12.1 | Registration status from countries with Stringent Regulatory Authorities where applicable |
1.12.2 | List of countries in which a similar application has been submitted |
1.12.3 | Statement on whether an application for the Marketing Authorisation has been previously rejected, withdrawn or repeatedly deferred in the East Africa Community Partner States |
1.12.4 | Certificates of approval of Drug Master File by Stringent Regulatory Authority |
1.12.5 | Manufacturing Licence and Product registration certificate/Licence |
1.13 | Name(s) and complete address (es) of the manufacturer(s) |
1.13.1 | Name and complete address(es)of the manufacturer(s) of the FPP, including the finished pharmaceutical product release if different from the manufacturer. |
1.13.2 | Name(s) and complete address (es) of the manufacturer(s) of the active pharmaceutical ingredient |
1.14 | Compliance to Good Manufacturing Practice and Good Clinical Practice |
1.14.1 | Good Manufacturing Practice from the Board |
1.14.2 | Good Clinical Practice or Good Laboratory Practice |
1.15 | Name and complete address of the Local Technical Representative of Manufacture (forfinished pharmaceutical Product) |
1.16 | Product Information: Summary of Product Characteristics, Prescribers/Patient information leaflet, Mock-ups and Photo scan of the product: |
1.17 | State the reference/monograph standard used for Finished Medicinal Product. |
1.18.1 | Specification of active ingredient(s) from active pharmaceutical ingredient manufacturer(Specification number and Version): |
1.18.2 | Specification of active ingredient(s) from FPP manufacturer (Specification number and Version): |
1.18.3 | Specification of Finished Pharmaceutical Product (Specification number and Version): |
1.19 | Name and address (physical and postal) of the Contract Research Organisation(s) where the clinical studies of the product were conducted. (If applicable) |
1.20 | DECLARATION BY AN APPLICANTThat information is true and correctName, position and signature ………………………………….Official stamp:…………………………..* Note: If fees have been paid, attach proof of payment |