Revised FDA Citizen's Charter ( FDA Memorandum Circular No. 004-15 )
February 17, 2015
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 Republic Act 9485 (Anti Red Tape Act of 2007).
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 IIIOIC, Director IV Food and Drug Administration