PRODUCT REGISTRATION AND RECALL

Question 1

Supply the missing words in the statement:

The FDA is in responsible of the _, _, and _ of the following products: (7)

Answer 1

The FDA is in responsible of the LICENSING, MONITORING, and REGULATION of the following products:
• Food and beverages
• Cosmetics
• Drugs and/or pharmaceuticals
• Medical devices
• Vaccines
• Household hazardous products
• Pesticide

Question 2

WHO IS REQUIRED TO REGISTER WITH THE FDA IN THE PHILIPPINES?
• If a company in the Philippines undertakes any of the following with FDA-regulated items, it must register with the FDA:

Answer 2

• Importing
• Exporting
• Wholesale trading
• Distribution
• Manufacturing

Question 3

HOW TO OBTAIN AN FDA PRODUCT REGISTRATION CERTIFICATE in the Philippines? (GENERAL REQUIREMENTS)

• Can you apply for an FDA certificate of product registration once you have your operating license?

• The FDA certificate is valid for how many years?

• Must the FDA certificate be renewed when it expires?

Answer 3

YES, you can apply for an FDA certificate of product registration once you have your operating license

The FDA certificate is valid for one to two years

YES, FDA certificate must be renewed when it expires

Question 4

HOW TO OBTAIN AN FDA PRODUCT REGISTRATION CERTIFICATE in the Philippines? (GENERAL REQUIREMENTS)

To apply for a product registration certificate, prepare the following:

Answer 4

1. Product labels
2. Product documents
3. Product Sample
4. Certificate of Analysis

Question 5

You must provide all product labels in all sizes. Include images of the product in all packaging sizes and perspectives. Labeling regulations need supporting documentation for logos/seals.

Answer 5

PRODUCT LABELS (under general requirements of FDA registration)

Question 6

Documents must back up product claims. Include physicochemical and microbiological requirements

Answer 6

PRODUCT DOCUMENTS (under general requirements of FDA registration

Question 7

This paper must provide vital product information. The data must be relevant to food safety.

Answer 7

CERTIFICATE OF ANALYSIS (under general requirements of FDA registration)

Question 8

You must also submit a product sample. Your sample must be complete with all labels and packaging.

Answer 8

PRODUCT SAMPLE (under general requirements of FDA registration)

Question 9

Supplement the missing words of the 14 CHECKLIST OF REQUIREMENTS (OVER-THE-COUNTER DRUGS AND HOUSEHOLD REMEDIES)

1. Duly accomplished and notarized _ _ _ (with proof of payment)
2. Proof of payment (based on AO No. _ s. _)
3. _ _ between the manufacturer, trader, importer, distributor, where _
4. _ _ and _ _
5. _ _ of all Raw Materials
6. _ _ _ of Active Raw Material(s)
   
   • From _ of API
   • From _ of finished product
7. _ _ of _ _
8. _ of _ of _ _ (from the _ batch of representative sample)
9. Manufacturing _, _, _, _, _ _, and _ _ _ (including specification for _ _ _)
10. _ and Other Test Procedures including _, _ _, with Data
11. _, where applicable
12. _ _
13. _ _ (_ labels)
14. _ _ (w/ _) may be submitted at a _ date, e.g. when the application has already been _ as indicated in the _ _ _ (upon request of the _).

Answer 9

1. Duly accomplished and notarized Integrated Application Form (with proof of payment)
2. Proof of payment (based on AO No. 50 s. 2001)
3. Valid agreements between the manufacturer, trader, importer, distributor, where applicable
4. Unit Dose and Batch Formulation
5. Technical Specifications of all Raw Materials
6. Certificate of Analysis of Active Raw Material(s)
   
   • From supplier of API
   • From manufacturer of finished product
7. Technical Specifications of Finished Product
8. Certificate of Analysis (CA) of Finished Product (from the same batch of representative sample)
9. Manufacturing Procedure, Production, Equipment, Sampling, In-process controls, and Master Packaging Procedure (including specification for container closure system)
10. Assay and Other Test Procedures including Identity, Purity Tests, with Data
11. Analysis, where applicable
12. Stability Studies
13. Labeling Materials (facsimile labels)
14. Representative Samples (w/ COA) may be submitted at a later date, e.g. when the application has already been decked as indicated in the Document Tracking System (upon request of the evaluator).

Question 10

Supplement the missing words in the ADDITIONAL REQUIREMENTS (OVER-THE-COUNTER DRUGS AND HOUSEHOLD REMEDIES)

1. For products in _ container:
   
   • Certificate of Analysis for Test of _ _ /_
2. For _ products:
   
   • Certificate of _ _ (_)
   • _ _ Clearance
3. For _ _:
   
   • _ of the _
4. Valid _ (Importer/Manufacturer/Distributor/Trader)

Answer 10

1. For products in plastic container: Certificate of Analysis for Test of Migratable Substances/Leachability
2. For imported products:
   
   • Certificate of Pharmaceutical Product (CPP)
   • Foreign GMP Clearance
3. For fixed-dose combination: Rationale of the Combination
4. Valid LTO (Importer/Manufacturer/Distributor/Trader)

Question 11

Give Part I: Administrative Data and Product Information of checklist of requirements of PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS

Answer 11

Part I: Administrative Data and Product Information
Sec. A: Introduction
Sec. B: Overall ASEAN Common Technical Dossier
Table of Contents
Sec. C: Guidance on the Administrative Data and Product Information

1. Duly accomplished and notarized Integrated
   Application Form (with proof of payment)
2. Letter of Authorization (where applicable)
3. Certifications
4. Site Master File
5. Labeling
6. Representative Sample with corresponding Certificate of Analysis (upon request of the evaluator)
7. Product Information
   
   • Package Insert
   • Summary of Product Characteristics (Product Data Sheet)

Question 12

Give the details about the certification in the checklist of requirements in PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS

Answer 12

• For contract manufacturing:
- License of pharmaceutical industries and contract manufacturer
- Contract manufacturing agreement
- GMP certificate of contract manufacturer

• For manufacturing “under-license”:
- License of pharmaceutical industries
- GMP certificate of the manufacturer
- Copy of “under-license” agreement

• For locally manufactured products:
- Valid License to Operate (LTO
(Manufacturer/Packer/Repacker/Trader/Distributor/ Wholesaler)
- Valid GMP certificate
- Valid agreement between the manufacturer, trader, distributor (where applicable)

• For imported products:
- Valid License to Operate (LTO)
(Packer/Repacker/Trader/Importer/Distributor/ Wholesaler)
- Valid Foreign GMP Clearance
- Valid Certificate of Pharmaceutical Product (CPP) issued by the
competent authority in the country of origin according to the
current WHO format
- Valid agreement between the manufacturer, trader, importer,
distributor (where applicable)

• For Dangerous Drugs (as per RA 9165 and Dangerous
Drugs Board):
- License to Handle Dangerous Drugs

Question 12

Give the details about the certification in the checklist of requirements in PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS

Answer 12

• For contract manufacturing:
- License of pharmaceutical industries and contract manufacturer
- Contract manufacturing agreement
- GMP certificate of contract manufacturer

• For manufacturing “under-license”:
- License of pharmaceutical industries
- GMP certificate of the manufacturer
- Copy of “under-license” agreement

• For locally manufactured products:
- Valid License to Operate (LTO
(Manufacturer/Packer/Repacker/Trader/Distributor/ Wholesaler)
- Valid GMP certificate
- Valid agreement between the manufacturer, trader, distributor (where applicable)

• For imported products:
- Valid License to Operate (LTO)
(Packer/Repacker/Trader/Importer/Distributor/ Wholesaler)
- Valid Foreign GMP Clearance
- Valid Certificate of Pharmaceutical Product (CPP) issued by the
competent authority in the country of origin according to the
current WHO format
- Valid agreement between the manufacturer, trader, importer,
distributor (where applicable)

• For Dangerous Drugs (as per RA 9165 and Dangerous
Drugs Board):
- License to Handle Dangerous Drugs

Question 13

Give Part II: Quality information of checklist of requirements of PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS

Answer 13

Part II: Quality
Sec. A: Table of Contents
Sec. B: Quality Overall Summary
Sec. C: Body of Data

Drug Substance (S)
Drug Product (P)

Question 14

Give the details about the drug substance in the part II checklist of requirements in PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS

Answer 14

S 1 General Information
S 1.1. Nomenclature
S 1.2. Structural Formula
S 1.3. General Properties
S 2 Manufacture
S 2.1. Manufacturer(s)
S 3 Characterization
S 3.1. Elucidation of Structure and Characteristics
S 3.2. Impurities
S 4 Control of Drug Substance
S 4.1. Specifications
S 4.2. Analytical Procedures
S 4.3. Validation of Analytical Procedures
S 5 Reference Standards or Materials
S 7 Stabilit7

Question 15

Give the details about the drug product in the part II checklist of requirements in PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS

Answer 15

P 1 Description and Composition
P 2 Pharmaceutical Development
P 2.2. Components of the Drug Product
P 2.2.1. Active Ingredients
P 2.2.2. Excipients
P 2.3. Finished Product
P 2.3.1. Formulation Development
P 2.3.2. Overages
P 2.3.3. Physicochemical and Biological Properties
P 2.5. Container Closure System
P 2.6. Microbiological Attributes
P 2.7. Compatibility
P 3 Manufacture
P 3.1. Batch Formula
P 3.2. Manufacturing Process and Process Control
P 3.3. Controls of Critical Steps and Intermediates
P 3.4. Process Validation and/or Evaluation
P 4 Control of Excipients
P 4.1. Specifications
P 4.2. Analytical Procedures
P 4.3. Excipients of Human and Animal Origin
P 5 Control of Finished Product
P 5.1. Specifications
P 5.2. Analytical Procedures
P 5.3. Validation of Analytical Procedures
P 5.4. Batch Analyses
P 5.5. Characterization of Impurities
P 5.6. Justification of Specifications
P 6 Reference Standards or Materials
P 7 Container Closure System
P 8 Product Stability
P 9 Product Interchangeability/Equivalence Evidence (if applicable)

Question 16

For Part II: Quality - Drug Substance (S), the following may be submitted:

Answer 16

Option 1: Full submission (S1-S7)

Option 2: Certificate of Suitability (CEP) –with sections/sub-sections: S1, S2.1, S4.4 and S7 (if retest period is not stated) only. Copy of the latest version of the CEP shall be provided.

Option 3: Active Pharmaceutical Ingredient
Master File (APIMF)

Question 17

ICH Common Technical Document format is acceptable provided that the products are approved in

Answer 17

ICH member countries / regions.

Question 18

Give the CPR Processing Steps

Answer 18

Step 1: DOWNLOAD
Step 2: Fill up form
Step 3: E-mail
Step 4: Scheduling
Step 5: Pay
Step 6: Check
Step 7: Submission.

Question 19

A CPR requires a valid

Answer 19

LTO

Question 20

The application form comprises six parts:

Answer 20

1) General
2) Establishment
3) Product
4) Supporting,
5) Sources and Clients
6) Applicant

Question 21

CPR PROCESSING: STEP 4 SCHEDULING

A _ _ _ with a submission timeline is sent within two days.

Answer 21

Document Tracking Log (DTL)

Question 22

Step 5: Pay
You can pay at _ branches or the _ . After
receiving a _, payment can be made immediately at any
_ branch. The main _ will only accept those scheduled for the day. Payment requires a copy of the _ and the _. Indicate the
_ in the application form. Verify that the _ in the DTL matches the evidence of payment.

Answer 22

Step 5: Pay
You can pay at Land Bank branches or the FDA cashier. After
receiving a DTL, payment can be made immediately at any
Land Bank of the Philippines branch. The main FDA cashier will
only accept those scheduled for the day. Payment requires a
copy of the FDA DTL and the application form. Indicate the
tracking number in the application form. Verify that the
tracking number in the DTL matches the evidence of payment.

Question 23

Step 6: Check
Verify all requirements are met. Ensure you have a checklist of
_ and the required _. Notarize the _ or _. To facilitate transmission, keep all _ on a USB device. Include a _ application form in XLS or XLSX. Keep your USB devices malware-free. A copy of the _ is also required

Answer 23

Step 6: Check
Verify all requirements are met. Ensure you have a checklist of
criteria and the required paperwork. Notarize the petition or
declaration form. To facilitate transmission, keep all
prerequisites on a USB device. Include a completed application
form in XLS or XLSX. Keep your USB devices malware-free. A
copy of the OnColl Payment Slip is also required

Question 24

Step 7: Submission. Application submitted on schedule. Only _ applications will be accepted. No longer will hard copies be required. Don't forget to return the _. Remember each application's _. Follow-up with the RSN at fdac@fda.gov.ph. If you can't finish on time, send an email to fdac@fda.gov.ph with the RSN.

Answer 24

Step 7: Submission. Application submitted on schedule. Only daytime applications will be accepted. No longer will hard copies be required. Don't forget to return the USB devices. Remember each application's RSN. Follow-up with the RSN at fdac@fda.gov.ph. If you can't finish on time, send an email to fdac@fda.gov.ph with the RSN.

Question 25

Guidelines on Product Recall General Guidelines 1. Triggers for recall may arise _ review of a _, _, if applicable and _ discovered by either _, the _, other regulatory agencies, healthcare professionals, or members of the general public. 2. A _ for each Center shall oversee the _ system for health products under their respective jurisdiction. All PRC’s report directly to the _ 3. Decision to recall shall be based on appropriate evaluation of available _ and applicable _, _ and _. 4. The overall responsibility of conducting recall lies with the _, including the conduct of appropriate _ with stakeholders, healthcare professionals and the public, following an effective and efficient _ strategy. 5. All other establishments involved in the _ shall coordinate and cooperate with the _. 6. The primary role of the FDA is to closely monitor and supervise the _ of the conduct of the _ by the _. Nonetheless, the FDA is not _ to _ and _ any regulatory action and to provide _, _ and _ advice. 7. _ is a key component in the conduct of Product recall.

Answer 25

Guidelines on Product Recall General Guidelines 1. Triggers for recall may arise after review of a safety issue, efficacy concern, if applicable and quality defect discovered by either FDA, the Market Authorization Holder, other regulatory agencies, healthcare professionals, or members of the general public. 2. A product Recall Committee (PRC) for each Center shall oversee the recall system for health products under their respective jurisdiction. All PRC’s report directly to the Office of the Director General 3. Decision to recall shall be based on appropriate evaluation of available evidences and applicable laws, rules and regulations. 4. The overall responsibility of conducting recall lies with the MAH, including the conduct of appropriate communication with stakeholders, healthcare professionals and the public, following an effective and efficient recall strategy. 5. All other establishments involved in the supply chain shall coordinate and cooperate with the MAH. 6. The primary role of the FDA is to closely monitor and supervise the effectiveness of the conduct of the recall by the MAH. Nonetheless, the FDA is not precluded to intervene and enforce any regulatory action and to provide scientific, technical and operational advice. 7. Risk Management Plan (RMP) is a key component in the conduct of Product recall.

Question 26

Product Recall Committee A PRC shall be created in each center, composed, at the minimum, of the following members: 1. _ 2. Division Chief, _ 3. Division Chief, _ 4. Senior Officer from the _ 5. Senior Officer from the _ 6. PRC Secretariat from _

Answer 26

Product Recall Committee A PRC shall be created in each center, composed, at the minimum, of the following members: 1. Director 2. Division Chief, Licensing and Registration Division 3. Division Chief, Product Research and Standards Development Divisions 4. Senior Officer from the Common Services Laboratory 5. Senior Officer from the Field Regulation Operations Office 6. PRC Secretariat from PRSDD

Question 27

Functions of the PRC • Review the _ for recall • Conduct appropriate _ •Oversee the _ system • Recommend the _ of recall and/or the _ of recall of any unsafe and hazardous product of the _

Answer 27

Functions of the PRC • Review the triggers for recall • Conduct appropriate communications •Oversee the recall system • Recommend the order of recall and/or the termination of recall of any unsafe and hazardous product of the FDA Director General

Question 28

Triggers for Recall Triggers may come from the different _ activities conducted by the _ which may include, but not limited to: 1. _ processing 2. _ monitoring and Events-based _ reports; 3. _, _ and _ of health products 4. _-licensing inspection, monitoring, and investigations 5. Post evaluation of acknowledge notifications 6. _ and _ articles monitoring 7. Coordination with _ agencies and _ partners

Answer 28

Triggers for Recall Triggers may come from the different post-marketing surveillance (PMS) activities conducted by the FDA which may include, but not limited to: 1. Health product quality/complaints processing 2. Adverse Events (AEs) monitoring and Events-based Surveillance Response (ESR) reports; 3. Sampling, Testing and verifying of health products 4. Post-licensing inspection, monitoring, and investigations 5. Post evaluation of acknowledge notifications 6. Advertisements and promotional articles monitoring 7. Coordination with regulatory agencies and international partners

Question 29

Product Recall Review • Review of _ The trigger that have been initially reviewed by the responsible offices are submitted to the _ for health evaluation. • Health Hazard Evaluation Health hazard evaluations conducted to determine whether a health product in question arising from a trigger should be _ or _ • Decision If a trigger is _ for recall: Conference with the _ The PRC prepare a _ containing information on (1) the _ and _ evidences (2) the result of the _ and (3) the recall _ as categorized:

Answer 29

Product Recall Review • Review of Trigger The trigger that have been initially reviewed by the responsible offices are submitted to the PRC for health evaluation. • Health Hazard Evaluation Health hazard evaluations conducted to determine whether a health product in question arising from a trigger should be recalled or not • Decision If a trigger is deemed for recall: Conference with the MAH The PRC prepare a Product Recall Resolutions (PRR) containing information on (1) the trigger and related evidences (2) the result of the health evaluation and (3) the recall classification as categorized: Class I, II and III

Question 30

product defects/conditions that are potentially life threatening or could result to severe health risk, health impairement or effects such as permanent damage to health or death.

Answer 30

Class I recall

Question 31

product defects/ conditions that could cause poisoning or temporary/medically reversible adverse health problem or mistreatment.

Answer 31

Class II recall

Question 32

product defects/conditions that may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons.

Answer 32

Class III recall

Question 33

The PRC shall call for a conference with the _ within _ hours to present the _. In the same event. MAH shall present their appropriate _ strategy. Agreement by both _ and _ on the recall strategy to be implemented must ensure for the commencement of the recall. Otherwise, a _ shall be issued and recall shall be implemented by the _ at the expense of the _. If not deemed for recall: The trigger is returned to the _ office for consideration of other more appropriate regulatory action.

Answer 33

The PRC shall call for a conference with the MAH within 48 hours to present the PRR. In the same event. MAH shall present their appropriate recall strategy. Agreement by both FDA and MAH on the recall strategy to be implemented must ensure for the commencement of the recall. Otherwise, a Product Recall Order (PRO) shall be issued and recall shall be implemented by the FDA ate the expense of the MAH. If not deemed for recall: The trigger is returned to the endorsing office for consideration of other more appropriate regulatory action.

Question 34

Product Recall Process • Recall Strategy A recall strategy consistent with the _ shall be developed by the _. The following elements shall be included: 1. _ of Recall, specify the level in the _ claim (e.g. consumer level, retail level or wholesale level) 2. Recall _ containing the identified list of establishments as per _ records to be contacted and contents of such communications. 3. Recall _ _and _ timelines of completion 4. Recall _ _ of MAH to FDA, specify the _ of submission. 5. _ strategy

Answer 34

3. Recall operation instructions and corresponding timelines of completion 4. Recall status reporting of MAH to FDA, specify the frequency of submission. 5. Disposal strategy

Question 35

Product Recall Process • Communications Activities Appropriate communications activities shall be undertaken by _ and the _ to protect the public. 1. Issuance of _ – An _ shall be issued for _ Recalls, and as deemed necessary and appropriate by FDA. Such Advisory shall be posted in the FDA website and/or other forms of media to alert the public. 2. Communications – The _ shall promptly _ all concerned parties (e.g. establishments involved in the supply chain, hospitals, outlets and health facilities, healthcare professionals and general public) on the _, copy furnishing the FDA.

Answer 35

Product Recall Process • Communications Activities Appropriate communications activities shall be undertaken by FDA and the MAH to protect the public. 1. Issuance of FDA Advisory – An FDA Advisory shall be issued for CLASS I Recalls, and as deemed necessary and appropriate by FDA. Such Advisory shall be posted in the FDA website and/or other forms of media to alert the public. 2. Communications – The MAH shall promptly notify all concerned parties (e.g. establishments involved in the supply chain, hospitals, outlets and health facilities, healthcare professionals and general public) on the product recall, copy furnishing the FDA.

Question 36

Product Recall Process • Recall _ The responsibility to conduct recall shall be assumed by the _, with proper coordination with all _ involved. Throughout the operation, recall _ _ shall be submitted according to the _ specified in the recall _. For _, products are immediately pulled out of the selling area.

Answer 36

Product Recall Process • Recall Operations The responsibility to conduct recall shall be assumed by the MAH, with proper coordination with all stakeholders involved. Throughout the operation, recall status report shall be submitted according to the frequency specified in the recall strategy. For CLASS I, products are immediately pulled out of the selling area.

Question 37

Product Recall Process • Completion of Product Recall Completion of recall operation refers to the complete _ of all products ordered to be recalled _ (both rural and urban) as verified by _. Upon completion, the _ is required to submit the _ _ _ Report, including details on the final _ and _ of the recalled products for the _ of the recall

Answer 37

Product Recall Process • Completion of Product Recall Completion of recall operation refers to the complete retrieval of all products ordered to be recalled nationwide (both rural and urban) as verified by FDA. Upon completion, the MAH is required to submit the Final Recall Status Report, including details on the final inventory and disposition of the recalled products for the termination of the recall

Question 38

Product Recall Process • Termination of Product Recall Upon receipts of the documents the _ shall verify if the product has been completely _ and has been properly _ in accordance with the strategy. a. If the PRC has determined that the product recall has been completed =, a _ Letter to that effect shall be issued to the _ indicating such. An _ advisory concerning the termination of the recall shall be issued, whenever applicable. b. If the PRC has determined that the product recall has _ _ satisfactorily completed, appropriate action shall conducted by FDA.

Answer 38

Product Recall Process • Termination of Product Recall Upon receipts of the documents the PRC shall verify if the product has been completely retrieved and has been properly disposed in accordance with the strategy. a. If the PRC has determined that the product recall has been completed =, a Termination Letter to that effect shall be issued to the MAH indicating such. An FDA advisory concerning the termination of the recall shall be issued, whenever applicable. b. If the PRC has determined that the product recall has not beem satisfactorily completed, appropriate action shall conducted by FDA.