Application Procedure and Documentation Requirements
- Applicants are entertained on a "first-come first-served" basis.
- For pharmaceutical products, a maximum of five applications per company are allowed per session.
- A slot number is issued to the company liaison officer to maintain order.
- The application package must include:
- One complete set of documents as prescribed by the checklist for product registration.
- A representative sample of the product in its commercial presentation for Product Standards and Development (PSD) evaluation.
- Documents should be enclosed in a plastic bag or envelope for ease of handling.
Payment and Forms
- Applicants must submit PAICS Form No. 99-01 titled "Classification of products for registration with corresponding fees," which aids in fee determination.
- The PAICS staff issues an Order of Payment based on the form.
- After obtaining the Order of Payment, the applicant proceeds to the Accounting Section for fee verification and then to the Cashiers Office for payment.
- The official receipt must be presented to PAICS staff for final acceptance of the application and issuance of a Routing Slip Number (RSN).
Renewal Applications for Pharmaceutical Products
- Renewal applications require stamping of the current Certificate of Product Registration (CPR) as "received" by PAICS staff.
- Follow-up inquiries are only entertained 90 days after receipt.
- A follow-up form issued by PAICS is required for status inquiries.
Policy on Completeness and Acceptance of Applications
- Applications are accepted at PAICS without prior PSD assessment.
- The submitted documents and PAICS Form 99-01 are presumed correct and complete upon submission.
- No additional documents will be accepted once the application is received by PAICS.
- PSD evaluates applications based on document completeness, accuracy, truthfulness, and acceptability of information.
- Abeyance letters (requests for additional documents or suspension of evaluation) will no longer be issued.
Fees and Classification of Registered Products
- Fees vary by product category and type of registration (initial, renewal, monitored release, etc.). Examples include:
- Processed Food Initial: P25.00
- Bottled Water Initial: P300.00
- Monitored Release Pharmaceutical: P6,000.00 Initial
- Generic Drug: P2,500.00 Initial, P1,500.00 Renewal
- Branded Drug: P1,500.00 Renewal
- Diagnostic Reagent: P25.00 Initial/Renewal
- Medical Device: P55.00 Initial, P150.00 Renewal
- Cosmetics: P55.00 Initial, P150.00 Renewal
- Household Hazardous Substance: P55.00 Initial/Renewal
Renewal Application Fees and Penalties
- A surcharge of 50% of the renewal fee applies to applications filed one day to 3 months after CPR expiration.
- Applications filed more than three months after expiration are treated and charged as initial registration.
Additional Payment and Refund Policy
- Any excess payment resulting from information provided in the PAICS Form 99-01 is non-refundable.
- Any underpayment detected will require additional fees from the applicant before releasing the CPR.
Effective Date and Implementation
- The revised process outlined takes effect immediately as of February 10, 1999.
- This circular streamlines and clarifies protocol for registration handling, aiming to improve efficiency and transparency in product registration regulated by BFAD.