APPLICATION FOR MARKETING AUTHORIZATION OF A PHARMACEUTICAL PRODUCT FOR HUMAN USE IN UGANDA

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1 National Drug Authority Plot No Lumumba Avenue, P.O. Box 23096, Kampala, Uganda. website: Doc. No.: DAR/FOM/170 Revision No.: 1 Effective Date: 21 June 2016 Tel: , /2 APPLICATION FOR MARKETING AUTHORIZATION OF A PHARMACEUTICAL PRODUCT FOR HUMAN USE IN UGANDA The application form is to be used for an application for a marketing authorisation of a pharmaceutical product for human use submitted to National Drug Authority. The application form should be duly filled with relevant information, dated signed and stamped appropriately. A separate application form is required for each product. For the purpose of registration the following products will be regarded as either being the same product or separate product applications. TYPE OF APPLICATIONS Application Same Separate 1. Each individual dosage form of a particular medicine 2. Variations of the active pharmaceutical ingredient (API) of a product 3. Tablets/Capsules/Suppositories/Lozenges a) Different pack-sizes of exactly the same strength and formulation. b) Different strengths and formulations. c) Uncoated and coated tablets of the same strength and formulation. 4. Syrups/Liquids/Solutions (excluding parenterals)/creams/ointments a) Different container sizes of the same strength and formulation. b) The same container size of different strengths and formulations. 5. Ampoules and Vials and Large Volume Parenterals a) Ampoules or single dose vials containing identical solutions of the same strength but of different volumes (i.e. resulting in different total doses). b) Ampoules containing solutions of different strengths. c) Ampoules and single dose vials containing e.g. dry powder, crystals of different mass. d) Ampoules and single dose vials containing the same respective masses of e.g. dry powder, crystals. e) Ampoules, single dose vials, as well as pre-filled disposable syringes and cartridges containing identical solutions of the same strength and same volume of liquid.

2 TYPE OF APPLICATIONS Application f) Dental cartridges containing different volumes of fluids of the same strength (provided the dose remains constant). Same Separate g) Ampoules containing water for injection, but of different volumes. h) Special ampoules of dry powder and water for injections contained in the same unit, but intended for mixing at the time of injection if water for injections is fully described in dossier. i) Ampoules containing identical solutions of different volumes used only as diluent in the reconstitution of a preparation for parenteral use. j) Multidose vials containing different volumes of the same strength and formulation with the same dosage schedule. k) Multidose vials and a single dose ampoule or vial of the same formulation if the single-dose ampoule or vial corresponds to the dose indicated for the multidose vial. l) Multidose vials containing dry powder of different mass of the same formulation, and the same concentration when reconstituted. m) An ampoule of diluent packed together with any preparation including biological medicines if diluent is fully described in dossier. n) Infusion solutions of the different volumes and of the same formulation which are packed in containers of exactly the same type of material depending on the relevant information submitted. o) Infusion solutions of the same formulation and of the same or different volume which are packed in containers made of different types of materials. p) A preparation, packed in plastic containers, intended to be marketed in glass containers containing the same volume and the same formulation. q) Products with the same strength and formulation but with different colours and/or flavours. r) Applications containing the same API(s) applying for additional indications which render the product in a different scheduling status, or different pharmacological classification, or have any other restrictions imposed other than the original application. s) Removal of antimicrobial preservative from single dose presentation of registered vaccine that included a preservative in the original approved formulation 6. Same formulation with different proprietary names whether of the same or different applicants Page 2 of 8

3 National Drug Authority Plot No Lumumba Avenue, P.O. Box 23096, Kampala, Uganda. website: Doc. No.: DAR/FOM/170 Revision No.: 1 Effective Date: 21 June 2016 Tel: , /2 APPLICATION FOR MARKETING AUTHORIZATION OF A PHARMACEUTICAL PRODUCT FOR HUMAN USE IN UGANDA Application Number Date of submission of the dossier [For NDA use only] [For NDA use only] MODULE 1: ADMINISTRATIVE INFORMATION 1.0 PARTICULARS OF THE PRODUCT 1.1 Type of the pharmaceutical product application Innovator: Generic Renewal* * If variation has been made, information supporting the changes should be submitted using the Guidelines for Variation of Registered Pharmaceutical Products for Human Use. 1.2 Proprietary Name 1.3 International Non-proprietary Name (INN) of the Active Pharmaceutical Ingredient (API) 1.4 Strength of Active Pharmaceutical Ingredient (API) per unit dosage form: 1.5 Name and address (physical and postal) of the Applicant. (Company) Page 3 of 8

4 1.6 Pharmaceutical Dosage form and route of administration* * List of standard terms for dosage forms and routes of administration is available in the Guidelines on Submission of Documentation for Marketing Authorization of Pharmaceutical Products for Human Use Dosage form: Route(s) of administration (use current List of Standard Terms) 1.7 Packing/pack size: 1.8 Visual description (Add as many rows as necessary) 1.9 Proposed shelf life (in months): Proposed shelf life (after reconstitution or dilution): Proposed shelf life (after first opening container): Proposed storage conditions: Proposed storage conditions after first opening: 1.10 Other sister pharmaceutical products registered or applied for registration Do you hold Marketing Authorization (s) of other pharmaceutical product (s) containing the same active substance (s) in the Uganda? If yes state; Product name (s), strength (s), pharmaceutical form (s): Marketing authorisation number(s): Indication(s): Have you applied for Marketing Authorization pharmaceutical product (s) containing the same active substance (s)? Product name (s), strength (s), pharmaceutical form (s): Indication(s): 1.11 Pharmacotherapeutic group and ATC Code Pharmacotherapeutic group: ATC Code: (Please use current ATC code) If no ATC code has been assigned, please indicate if an application for ATC code has been made: Page 4 of 8

5 1.12 Distribution category: Controlled Drug POM Pharmacy Only OTC General sale (Applicants are invited to indicate which categories they are requesting, however, NDA reserves the right to change and/or apply only those categories provided for in their national legislation) 1.13 Country of origin: 1.14 Product Marketing Authorisation in the country of origin (Attach Certificate of Pharmaceutical Product). If not registered, state reasons Authorised Withdrawn (by applicant after authorisation) Date of authorisation (dd-mm-yyyy): Proprietary name: Authorisation number: Refused Date of refusal (dd-mm-yyyy): Reason for Refusal: Date of withdrawal (dd-mm-yyyy): Proprietary name: Reason for withdrawal: Suspended/revoked (by competent authority) date of suspension/revocation (dd-mm-yyyy): Reason for suspension/revocation: Proprietary name: 1.15 List EAC countries and SRAs where the product is approved Name(s) and complete physical address(es) of the manufacturer(s) Name(s) and physical address(es) of the manufacturing site of the finished pharmaceutical product (FPP), including the final product release if different from the manufacturer. Alternative sites should be also declared here. All manufacturing sites involved in the manufacturing process of each step of the finished product, stating the role of each including quality control / in-process testing sites should be listed. (Add as many rows as necessary) Page 5 of 8

6 Name(s) and physical address(es) of the manufacturer(s) of the active pharmaceutical ingredient(s) (API) (Add as many rows as necessary) All manufacturing sites involved in the manufacturing process of each source of active substance, including quality control / in-process testing sites should be listed Name and address (physical and postal) of the Local Technical Representative / agent(attach acopy of Notarised power of attorney for the local technical representative /agent)if applicable) 1.18 Name and address (physical and postal) of the person or company responsible for pharmacovigelance 1.19 State the reference/monograph standard such as British Pharmacopeia, United States Pharmacopeia, Ph. Eur., In-house monograph e.t.c. used for Finished Pharmaceutical Product. Qualitative and Quantitative composition of the active substance(s) and excipient(s) 1.20 A note should be given as to which quantity the composition refers (e.g. 1 capsule). Page 6 of 8

7 Name of active ingredient(s)* e.t.c Name Excipient(s) e.t.c Quantity / dosage unit Unit of measure Reference/ monograph standard Note: * Only one name for each substance should be given in the following order of priority: INN**, Pharmacopoeia, common name, scientific name ** The active substance should be declared by its recommended INN, accompanied by its salt or hydrate form if relevant. Details of averages should not be included in the formulation columns but should be stated below: - Active substance(s): - Excipient(s): 1.21 Name and address (physical and postal) of the Contract Research Organisation(s) where the clinical studies of the product were conducted. (If applicable) 2.0 DECLARATION BY AN APPLICANT I, the undersigned certify that all the information in this form and accompanying documentation is correct, complete and true to the best of my knowledge. I further confirm that the information referred to in my application dossier is available for verification during GMP inspection. I also agree that I shall carry out pharmacovigelance to monitor the safety of the product in the market and provide safety update reports to the National Drug Authority. I further agree that I am obliged to follow the requirements of the National Drug Authority. Page 7 of 8

8 Legislations and Regulations which are applicable to pharmaceutical products. It is hereby confirmed that fees will be paid/have been paid according to the national/ Community rules*... Position in the company: Signature:. Date:.. Official stamp:.. * Note: If fees have been paid, attach proof of payment 3.0 DOCUMEN REVISION HISTORY Date of revision Revision number Document Number Author(s) Changes made and/or reasons for revision 15 June DAR/FOM/170 NDA Secretariat Changed document into new QMS format and to match the CTD format Page 8 of 8