Study Set Content:
user name of the last user who delegated the case
Sent By
due date by which the task ends
Due date
date by which the application was last modified
Last Modify
level of priority of a case (all applications are, by default, of Normal priority). Other folders in the navigation pane will display a similar tabular presentation of information as shown in the figure below.
Priority
displays all cases started but not fully accomplished
Draft
displays all applications with completed tasks
Participated
displays all applications with no current user delegated
Unassigned
displays all paused applications
Paused
This displays dynamic content, depending on the selected folder in the navigation pane.
Window
The process consists of 4 (four) main parts:
1. Submission, 2. Payment, 3. Download Result, and 4. Revalidation.
1. () the FDA e-Portal at https://www.fda.gov.ph 2. () by entering the username and password of the provided CCRR User account.
Access, Login
. In the HOME tab, select () in the navigation pane to proceed to the notification form.
New case
4. Accomplish the notification form as provided in parts by the application wizard. Fill-in the fields as completely as possible. Fields marked with a () are required to be filled-in. Mark fields with (), if not applicable
red asterisk (*), Not applicable
5. An() will be generated at the end of the step
assessment slip
Download the generated assessment slip by clicking
Open
To continue with your application, click Next. The application will then be placed in the () folder in the navigation pane.
Participated
o The status of the application may be checked in the Participated folder as indicated by the()column.
Task
GUIDELINES IN FILLING THE NOTIFICATION FORM
Declaration
Particulars of the Product
LOCAL COMPANY RESPONSIBLE FOR PLACING THE PRODUCT IN THE MARKET
Details of the person representing the company
1. DECLARATION ¨ Proceed with the application by selecting your response using the dropdown list and clicking
Continue
2. PARTICULARS OF THE PRODUCT ¨ Validity of the notification may be either be () years at the option of the applicant.
1, 2, or 3
