Study Set Content:
If approved, download and print the notice of ()
acknowledgement
7. For more information, you may download the following for your reference/ guidance:
FDA Memorandum Circular No, 2015-010
FDA Memorandum Circular No, 2015-011
Cosmetic e-Notification v.2.0 Booklet for Applicants
Outline
Background
FDA E-PORTAL
APPLICATION PROCEDURE
BUSINESS PROCESS FLOW
APPLICATION PROCEDURE
¨ Submission ¨ Payment ¨ Result of Application ¨ Revalidation
With the adoption and implementation of the () by virtue of ()(), the notification scheme for cosmetic products was implemented.
ASEAN Harmonized Cosmetic Regulatory Scheme in 2—5, DOH Administrative Order No. 2005-0015 and 2005-0025
This was first fully implemented as a manual application process through ()
FDA Bureau Circular No. 2007- 013-A.
The application process went electronic in March 2013 through (). This shift aimed to streamline the process by updating the submission of application requirements from the previously manual form to online submissions.
FDA Memorandum Circular No. 2013-011
¨ In August 2015, to further enhance the efficiency of the application process and transparency of information, the cosmetic product notification scheme was updated and incorporated in the ().
FDA E-Portal
This is accessible via https://www.fda.gov.ph, and is the portal for several types of applications filed electronically with the FDA. Users of the E-Portal are provided with accounts to access the processes. Using this portal, tasks (i.e. steps in the procedure) are accomplished in a simple workflow, and cases (i.e. applications) are filed using specialized forms.
FDA E-PORTAL?
The interface may be linked to common e-mail programs. It has two key parts.
Navigaition pane and Window
Found at the left side of the interface
Navigation pane
selected when an applicant wishes to apply for a new application; when ()is selected in the navigation pane, the window displays the list of processes which may be availed by the applicant. To proceed with submitting an application, the user may select from the list their preferred process to be undertaken
‘New Case’
displays all current tasks delegated to the use
Inbox
when ()’ is selected in the navigation pane, the window displays the list of applications that are currently for further action (i.e. pending tasks) by the user. It is a tabular representation with columns provided for:
‘Inbox
#
case number
Summary –
Summary of application
notes on application by authorized users
Case Notes
name of the application
Case
process where the application is lodged
Process
– current task to be undertaken for the application
Tasks
