Download Application form revision 1/1/2017

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: ……………………………………