INTERAGENCYPHARMACEUTICALPRODUCTQUESTIONNAIRE.docVIP

Page  PAGE 8 of  NUMPAGES 8 Annex 02 – DP 046 - Pre-qualifying and approving pharmaceutical and vaccine suppliers and products/ Rev. 03/September 2008. INTERAGENCY PHARMACEUTICAL PRODUCT QUESTIONNAIRE Note for the applicant: Please note that the information in this questionnaire can be shared confidentially among WHO, ICRC, MSF and UNICEF for procurement purposes. If you have any objection, please indicate to the relevant agency that you are dealing with. Product identification - Active Pharmaceutical Ingredient(s) (use INN if any): …………..……………………………………………………………………………………………………………...… - Generic name of the product: …..……………………………………………………….………………………………………….…………………….. - Trade name (if any): ………………………………………………………………………………………….……………………………… - Dosage form: ? Tablets ? Capsules ? Injectable ? Syrups/oral liquids ? Other: (Please specify) ………………………………………………………………………………………... - Strength per dosage unit: …………………………………………………………………………….…………………………. - Route of administration: ? Oral ? I.M. ? I.V. ? S.C. ? Other (Please specify) - Please provide the formulation of the product (complete qualitative and quantitative composition including active ingredient(s) and excipients). - Description and materials used for primary packaging e.g. HDPE bottle, Alu-Alu strip, neutral glass vial and pack size (quantity of dosage-form units per pack): ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….……………………………………………………………. - Pack size and Description of secondary packaging materials: ………………………………………………………………………….…………………………… - Please provide a flow diagram describing the manufacturing and control processes with relevant parameters.  II. Manufacturer identification - Name, address and activities of the manufacturer and manufacturing site(s) (or contract manufacturer(s)): Name of Manufacturer, Contract Manufacturer if any Reference of manufacturing license, date and expiry date, if any  Physical addres