FDA Memorandum Circular No. 004-15

February 17, 2015

FDA MEMORANDUM CIRCULAR NO. 004-15

TO	:	All FDA Centers/Offices and FDA Regulated Establishments

SUBJECT	:	Revised FDA Citizen's Charter

Please be informed that the Civil Service Commission (CSC) has approved the Food and Drug Administration's (FDA's) proposal to revise the FDA Citizen's Charter as part of its on-going commitment to improve compliance with

The revised durations of process are as follows:

	Services		Responsible Office	Duration of
				Processes

1	Filing and receiving of applications		Public Assistance,	5 calendar days
				Information and
				Receiving (PAIR)
				Unit

2	Inspection/Issuance of Certificate of		Regional Field Offices	61 calendar days
	Compliance

3	Issuance of License to Operate		CCRR, CDRR, CFRR	30 calendar days

4	Issuance of Certificate of Product of		CDRR
	Registration (CPR)

		Initial		254 calendar days
		Renewal		68 calendar days
		Automatic Renewal		33 calendar days
		CLIDP		31 calendar days
		Variations		52 calendar days

5	Issuance of Certificate of Product of		CFRR
	Registration (CPR)

		Initial/Renewal		114 calendar days
		Automatic Renewal/		57 calendar days
		Re-application/Probationary
		Permit to Market (PPM)

6	Issuance of Certificate of Product of		CCRR
	Registration (CPR)/Notification

		Cosmetic Notification		14 calendar days
		HUHS Notification		14 calendar days
		HUP CPR	- Initial	175 calendar days
			- Renewal	28 calendar days
		Toys and Childcare Articles		30 calendar days
		(TCCA)
		TCCA Certificate of
		Conformity - Compliant		42 calendar days
			- with deficiencies	64 calendar days

7		Batch Notification	Central	2 calendar days
		Lot Release Certificate	Laboratory	9 calendar days
		Laboratory Test Report		7 to 80 calendar
				days
8	Issuance of Other Certifications/
	Permits

		Certificate of Pharmaceutical
		Products (CoPP)	CDRR	14 calendar days
		Certificate of Free Sale (CFS)	CDRR/CCRR	14 calendar days
		Export Certificate (EC)	CDRR/CCRR	14 calendar days
		Food Export and Commodity	Central	2 calendar days
		Clearance	Laboratory
		Sales Promotion and	CCRR, CDRR,	14 calendar days
		Advertisement Permit	CFRR

The FDA will periodically review its systems and processes to continually improve the committed turn around time. ETIcHa

This order shall take effect on 02 March 2015.

For your guidance and strict compliance.

(SGD.) ATTY. NICOLAS B. LUTERO III, CESO III
OIC, Director IV
Food and Drug Administration