Revised FDA Citizen's Charter
The FDA Memorandum Circular No. 004-15, issued on February 17, 2015, announces the revised Citizen's Charter of the Food and Drug Administration (FDA) following approval from the Civil Service Commission. This revision aims to enhance compliance with the Anti Red Tape Act of 2007 and outlines the updated processing durations for various FDA services. Key services include filing applications (5 days), inspections (61 days), and product registrations, with initial registrations varying from 175 to 254 days depending on the product type. The FDA commits to periodic reviews of its processes to improve turnaround times, with the changes effective from March 2, 2015.
Quick Answers
- What is Revised FDA Citizen's Charter about?
- The FDA Memorandum Circular No. 004-15, issued on February 17, 2015, announces the revised Citizen's Charter of the Food and Drug Administration (FDA) following approval from the Civil Service Commission. This revision aims to enhance compliance with the Anti Red Tape Act of 2007 and outlines the updated processing durations for various FDA services. Key services include filing applications (5 days), inspections (61 days), and product registrations, with initial registrations varying from 175 to 254 days depending on the product type. The FDA commits to periodic reviews of its processes to improve turnaround times, with the changes effective from March 2, 2015.
- What type of law is FDA Memorandum Circular No. 004-15?
- Revised FDA Citizen's Charter (FDA Memorandum Circular No. 004-15) is a Philippine Other Rules and Procedures enacted by the Congress of the Philippines.
- When was Revised FDA Citizen's Charter enacted?
- Revised FDA Citizen's Charter (FDA Memorandum Circular No. 004-15) was enacted on Feb 17, 2015.
- What is the citation for Revised FDA Citizen's Charter?
- Revised FDA Citizen's Charter, FDA Memorandum Circular No. 004-15, Feb 17, 2015 (Philippines)
Law Information
- Reference Number
- FDA Memorandum Circular No. 004-15
- Date Enacted
- Category
- Other Rules and Procedures
- Subcategory
- Food and Drug Administration
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
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
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||
|
|
|
|
Processes
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| 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
Cite This Law
Revised FDA Citizen's Charter, FDA Memorandum Circular No. 004-15, Feb 17, 2015 (Philippines)
Revised FDA Citizen's Charter, FDA Memorandum Circular No. 004-15 (Phil. 2015)
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