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Application form revision 1/1/2017 INFANT FORMULA APPLICATION STEP 1: (APPLICATION TYPE) Active Ingredient Type: …………………………………….. Submission type: Local Import Marketing Authorization Holder (MAH) Country: ……………………………………………………….. Name of MAH: …………………………………………………. Office Address: ……………………………………………………... STEP 2: (PRODUCT INFORMATION) 4.1. GENERAL INFORMATION Product Information In Jordan Proposed Trade Name in Jordan: …………………………… Net Weight or Volume: …………………………………. Dosage Forms: …………………………………….. Type of Container (Primary Packaging): ……………………………. Secondary Packaging: …………………………………. Shelf Life: ……………………………………….. Administration Device: ……………………………………….. Package Size: ………………………………………………………………. Drug registration Department Application form revision 1/1/2017 Drug registration Department Product Information In Country of Origin (COO) Copy Jordan Information Trade Name in Country of Origin: …………………………………… Net Weight or Volume in Country of Origin: ……………………………… Country of Origin Dosage Form: ……………………………………. Type of Container in Country of Origin (Primary Packaging): ……………………… Secondary Packaging: ……………………………… Shelf Life: ………………………………… Country of Origin Administration Device: …………………………….. Package Size: …………………………………………………………………… 4.2. PACKAGING INFORMATION Shelf Life In Nearby Arab Countries: …………………………………………………………. Shelf Life after First Opening Container: ……………………………………………. Important Preparation Instructions: …………………………………. Storage Conditions: …………………………………. Storage Conditions after First Opening: ……………………………………. Proposed Changes in Physical and Chemical Characteristics Of The Product During Storage Transport And Distribution At 20, 30, 40 C: ………………………………………………………………………………………………………………. Instructions for Transport and Storage: ……………………………………….. 4.3. OTHER INFORMATION Invoicer: ……………………………. Suggested Price for the formula: ……………………………. Shipment Country: ………………………………. Application form revision 1/1/2017 Drug registration Department Certificate of Free Sales (FSC) Do you have an FSC for the Same Formula in COO? If Yes; Country of FSC: ………………………….. , FSC Number: …………………………… If No; Do You Have A Similar Formula Sold in COO? If Yes; Specify the Country That Sold The similar Formula: ……………………………. Certificate NO: …………………………………… If No; Do you have FSC from a reference country? If Yes; Country of Certificate: ……………………………. , Certificate Number:…………………………………. If No; Reason: ……………………………… Quality Control Measures: ……………………………………………………………………….. STEP 3: (COMPOSITION) Country of Origin List of Compositions Ingredient Name: ……………………………………… Ingredient Sub Name: ……………………………. Ingredient Source: ……………………………………. Manufacturer Name: ……………………………… Manufacturer Country of origin: ……………………………………….. Ingredient shelf life: ………………………………… Type of Container of Ingredient: …………………………………… Application form revision 1/1/2017 Drug registration Department Exported To Jordan List of Compositions Ingredient Name: ……………………………………… Ingredient Sub Name: ……………………………. Ingredient Source: ……………………………………. Manufacturer Name: ……………………………… Manufacturer Country of origin: ……………………………………….. Ingredient shelf: ………………………………… Type of Container of Ingredient: …………………………………… Formulas Differences & Reasons In case of any differences between the two formulas indicate the difference and specify the reason? ...................................................................................... STEP 4: (AVERAGE COMPOSOTION) Add New Average Composition Country of Origin List of Average Compositions Name of Nutrients: ……………………… Nutrient Sub Type Name: ……………………… Percentage per 100 GM: ………………………… Percentage per 100 Kcal: ……………………………. Exported To Jordan List of Average Compositions Name of Nutrients: ……………………… Nutrient Sub Type Name: ……………………… Percentage per 100 GM: ………………………… Percentage per 100 Kcal: ……………………………. STEP 5: (RECOMENDED USE) Recommended age for using the product: …………………………. Dietary Use / Management Of: ……………………………….. Warnings / Contra Indications (Cases When It Should Not Be Used): ………………………………… Application form revision 1/1/2017 Drug registration Department Experimental and Nutritional Studies: ……………………………………… Status of the Application in Other Regulatory Agencies / Other Information: ……………………………………. STEP 6: (MANUFACTURERS) Is this product under-license? If Yes; Name of licensor: …………………………. Finished Product Manufacturing Sites: Complete Contract Add new finished product manufacturer: Manufacturing site type: …………………………………. Country: ……………………………… Name of manufacturer: …………………………… Production line: ………………………………….. Plant Address: ……………………………………