OUR LADY OF FATIMA UNIVERSITY

College of Pharmacy

PRODUCT REGISTRATION
AND RECALL
PUBLIC HEALTH & REGULATORY
PHARMACY
(Supervised Pharmacy Practice Experience)
ACTIVITY:

• ON-LINE LECTURE
THROUGH ZOOM
• DURATION: 2 HOURS
• TOPIC: PRODUCT
REGISTRATION AND
RECALL
OUTCOMES:
• At the end of the lecture, the students
should be able:
• To identify the FDA's product registration
standards.
• To recognize the steps required to get a
certificate of product registration from the
FDA.
• To determine the procedure for product
monitoring.
• To identify the reasons for the cancellation
of product registrations.
• To familiarize with the procedure for
performing a product recall.
OUTLINE:

• Checklist of
requirements for product
registration
• Process in the granting of
Certificate of Product
Registration (CPR).
• Product Monitoring
procedure
• Cancellation of CPR
• Procedure of product
recall
FOOD AND DRUG ADMINISTRATION
• A number of products in the Philippines are
subject to regulation by the Food and Drug
Administration (FDA).
• Food, medical and pharmaceutical
products, and cosmetics are examples of
such products. A company that deals in these
products is required to have an FDA certificate
in order to register their products.
• The Food and Drug Administration
(FDA) is a government department that
is under the Department of Health.
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
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:

• Importing
• exporting
• wholesale trading
• Distribution
• Manufacturing
How to Obtain an FDA Product
Registration Certificate in the
Philippines (GENERAL REQUIREMENTS)
• 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 and must be renewed when it
expires.

• To apply for a product registration certificate,

prepare the following:
• Application form
Cont…(REQUIREMENTS)
• Product labels. - 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.
• Product documents. - Documents must
back up product claims. Include
physicochemical and microbiological
requirements.
Cont…(REQUIREMENTS)
• Certificate of Analysis - This paper
must provide vital product
information. The data must be
relevant to food safety.
• Product Sample - You must also
submit a product sample. Your
sample must be complete with all
labels and packaging.

***You must also pay the registration fee.

CHECKLIST OF REQUIREMENTS
(OVER-THE-COUNTER DRUGS AND HOUSEHOLD
REMEDIES)
• Duly accomplished and notarized Integrated
Application Form (with proof of payment)
• Proof of payment (based on AO No. 50 s. 2001)
• Valid agreements between the manufacturer,
trader, importer, distributor,
• where applicable
• Unit Dose and Batch Formulation
• Technical Specifications of all Raw Materials
• Certificate of Analysis of Active Raw Material(s)
• From supplier of API
• From manufacturer of finished product
Cont… (OVER-THE-COUNTER DRUGS AND HOUSEHOLD REMEDIES)
• Technical Specifications of Finished Product
• Certificate of Analysis (CA) of Finished Product
(from the same batch of
• representative sample)
• Manufacturing Procedure, Production,
Equipment, Sampling, In-process
• controls, and Master Packaging Procedure
(including specification for
• container closure system)
Cont… (OVER-THE-COUNTER DRUGS AND HOUSEHOLD REMEDIES)
• Assay and Other Test Procedures including
Identity, Purity Tests, with Data
• Analysis, where applicable
• Stability Studies
• Labeling Materials (facsimile labels)
• 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).
Cont… (OVER-THE-COUNTER DRUGS AND HOUSEHOLD REMEDIES)

Additional Requirements:
• For products in plastic container: Certificate of
Analysis for Test of Migratable Substances /
Leachability
• For imported products:
• Certificate of Pharmaceutical Product (CPP)
• Foreign GMP Clearance
• For fixed-dose combination: Rationale of the
Combination
• Valid LTO
(Importer/Manufacturer/Distributor/Trader)
CHECKLIST OF REQUIREMENTS
(PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

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
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

• For contract manufacturing:

a. License of pharmaceutical industries and
contract manufacturer
b. Contract manufacturing agreement
c. GMP certificate of contract manufacturer
• For manufacturing “under-license”:
a. License of pharmaceutical industries
b. GMP certificate of the manufacturer
c. Copy of “under-license” agreement
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

For locally manufactured products:

a. Valid License to Operate (LTO)
(Manufacturer/Packer/Repacker/Trader/Distributor/ Wholesaler)
b. Valid GMP certificate
c. Valid agreement between the manufacturer, trader, distributor
(where applicable)
• For imported products:
a. Valid License to Operate (LTO)
(Packer/Repacker/Trader/Importer/Distributor/ Wholesaler)
b. Valid Foreign GMP Clearance
c. Valid Certificate of Pharmaceutical Product (CPP) issued by the
competent authority in the country of origin according to the
current WHO format
d. Valid agreement between the manufacturer, trader, importer,
distributor (where applicable)
• For Dangerous Drugs (as per RA 9165 and Dangerous
Drugs Board):
a. License to Handle Dangerous Drugs
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

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)
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

Part II: Quality

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

Drug Substance (S)

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
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

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 Stability
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

Drug Product (P)

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
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

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
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

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)
Cont…. (PRESCRIPTION GENERIC PHARMACEUTICAL PRODUCTS)

Note:
• For Part II: Quality - Drug Substance (S), the
following may be submitted:
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)
• ICH Common Technical Document format is
acceptable provided that the products are
approved in ICH member countries / regions.
The CPR Processing Steps
Step 1: DOWNLOAD
The form is available at www.fda.gov.ph. It is used for
both License and Registration applications, as well as
modifications and other certificates. The application form
now covers promotions and advertisements. A CPR
requires a valid LTO.
Sep 2: Fill up form
The application form is completed. It comprises six parts:
1) General, 2) Establishment, 3) Product, 4) Supporting, 5)
Sources and Clients, 6) Applicant. If the part is correctly
filled, a green 'PROCEED' appears. Required fields are
ordered. Fill in the form and the constructed body text (in
the green box) will appear.
The CPR Processing Steps
Step 3: E-mail
Email [email protected]. The XLS application form's 'Email'
worksheet composes the subject and body of the email to
[email protected]. Paste the fields into the email. CC as
needed. The XLS or XLSX file is not required to be
connected. Any attachment will result in scheduling
rejection. One email might contain up to ten applications.
Step 4: Scheduling
A Document Tracking Log (DTL) with a submission
timeline is sent within two days. The FDA will schedule
applications based on the Centers' priorities. There will be
a daily quota for how many applications can be planned.
Emailing several applications can schedule them over
multiple days. Specific timetable requests will not be
honored. It takes 10 working days to schedule a receiving.
The CPR Processing Steps
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.
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.
The CPR Processing Steps
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 [email protected]. If
you can't finish on time, send an email to
[email protected] with the RSN.
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
Guidelines on Product Recall
General Guidelines
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.
Guidelines on Product Recall
General Guidelines
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.
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
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.
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.
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.
Product Recall Review
• 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 1 Recall – 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.
Cont… (Decision)

CLASS II Recall – product defects/

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

CLASS III Recall – product

defects/conditions that may not pose a
significant hazard to health, but withdrawal
may have been initiated for other reasons.
Cont… (Decision)

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.
Product Recall Process
• Recall Strategy
A recall strategy consistent with the RMP
shall be developed by the MAH. The following
elements shall be included:
1. Depth of Recall, specify the level in the
distribution claim (e.g. consumer level, retail
level or wholesale level)
2. Recall communications containing the
identified list of establishments as per
distribution records to be contacted and
contents of such communications.
Cont.. (Recall Strategy)
The following elements shall be
included:
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
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.
Cont… (Communications Activities)

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.
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.
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.
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.
ACTIVITIES FOR
NEXT MEETING
REFERENCES:

• https://www.fda.gov.ph/wp-
content/uploads/2021/05/Initial
-Registration-of-Over-The-
Counter-Drugs-and-Household-
Remedies.pdf
ANY QUESTIONS?