CHAPTER 1

Introduction

The Food and Drug Administration of the Philippines (formerly called

the Bureau of Food and Drugs) was created under the Department of Health to
license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices,
and household hazardous waste in the Philippines. Their general functions are:
Develops plans policies, programs and strategies for regulating processed foods,
drugs and other related products; Formulates rules, regulations and standards for
licensing and accreditation of processed foods, drugs and other related products;
Conducts licensing and accreditation of processed foods, drugs and other related
products; Provides technical, consultative and advisory services to and develops
capability of field offices on licensing and enforcement of laws, rules and regulations
pertaining to processed foods, drugs and other related products; Monitors, evaluates
and ensures compliance of manufacturers, distributors, advertisers and retailers of
processed foods, drugs and other related products to health rules and regulations
and standards of quality; Advises the Secretary and Undersecretary of Health on
matters pertaining to regulation of processed foods, drugs and other related
products. The Food and Drug Administration was enacted under Republic Act 9711
or the Food and Drug Administration (FDA) Act of 2009. It is declared by the state to
adopt, support, establish, institutionalize, improve and maintain structures,
processes, mechanisms and initiatives that are aimed, directed and designed to:
protect and promote the right to health of the Filipino people; and help establish and
maintain an effective health products regulatory system and undertake appropriate
health manpower development and research, responsive to the country's health
needs and problems. Pursuant to this policy, the State must enhance its regulatory
capacity and strengthen its capability with regard to the inspection, licensing and
monitoring of establishments and the registration and monitoring of health products.
The objectives of this research are: To provide adequate information with the
administrative and technical capacity of the Food and Drugs Administration in the
regulation of establishments and products under its jurisdiction; To elaborate the
importance of the Food and Drugs Administration monitoring and regulatory
coverage over establishments and products under its jurisdiction; and to provide
information in obtaining Certificate of Product Registration (CPR) for the
establishment of products in the market.

Food and Drug Administration (FDA) is a government office under the

Department of Health. It ensures the safety of public health. Food and Drugs
Administration (FDA) conducts different examination on products of food, drugs,
cosmetics, medical devices, and household hazardous waste and any product that
will be for intake or to be used in the body. Food and Drugs Administration (FDA)
issue a Certificate of Product Registration (CPR) on products that undergo extreme
lab examination. A product of the same brand but differ on variant, dosage strength,
flavor and others will have its own registration number. Even a small difference will
be given a different. According to recent studies conducted, there are importers that
do not register their imported commodities under Food and Drugs Administration, in
lieu of this, the shipments were being hold by the Bureau of Customs due to the lack
of permits and clearances from the respective agencies and departments. Under
Food and Drugs Administration (FDA), alcoholic and non– alcoholic beverages
should obtain permits from their office, as well as, the Client Profile Registration
System (CPRS).

The researchers will identify the possible effect of the Certificate of Product
Registration in the alcohol and non – alcoholic beverages. It seeks to answer the
following:
Statement of the Problem;

What are the struggles encountered by customs brokers and importers in obtaining
Certificate of Product Registration in Alcoholic and Non-Alcoholic Beverages?

1. What are the struggles in obtaining Certificate of Product Registration?

a. Permits
b. License
2. Possible effects of Certificate of Product Registration
a. Alcohol Product
b. Non – Alcoholic Product
3. Purpose of Certificate of Product registration.
4. Existing Memorandums and Circulars pertaining to Certificate of
Product Registration.

Problems being encountered for Administrative Order No. 2014-030 Mandatory

Labeling Requirements for registration of Certificate of Product Registration in
Alcoholic and Non-Alcoholic Beverages.

Rationale:

The study aims to understand the process of obtaining Certificate of Product

Registration and formulate a standard operation procedure that will benefit the
stakeholders of the Bureau Of Customs for trade facilitation. The study focuses on
creating an effective and efficient way of standard operating procedure that will solve
the current dilemmas faced by the Importers and Customs Brokers pertaining to the
procedure of obtaining certificate of product registration
CHAPTER 2

REVIEW OF LITERATURE

Department of Health agency of the Philippine government. Ensuring basic

health of the public through public service to all the Filipinos, provision of quality
health care and regulation in providers of health goods and other services.

Given the mandate, DOH is both a stakeholder in the health sector and a policy and
regulatory body for health. As a major player, DOH is a technical resource, a
catalyser for health policy and a political sponsor and advocate for health issues in
behalf of the health sector

FDA stands for Food and Drug Administration, an agency governed by the
government mainly responsible for safety of food, dietary supplements, human
drugs, vaccines, blood products and other biologicals, medical devices, radiation-
emitting electronics, cosmetics, veterinarian products and tobacco products. That
will be sold or manufactured in a country. The FDA also inspects and enforces
regulations related to these industries.

Companies or any related business pertaining to manufacturing, re-pack or re-label

products in the aforementioned industries must be licensed or registered with FDA,
exception is cosmetic industry whereas its voluntary to be registered.

Every department and industries will have a different process in applying to be

registered, but every registered business will have an annual registration.

(https://certifications.thomasnet.com/certifications/glossary/other-
certification_registration/fda/fda-registered/, n.d.)
Companies that are being focused on the development of a product and for the sale
of the product, it can result for its product not to be registered to raise more revenue.
The influence of Food and Drugs Administration registration can affect the stock
market. The release of registration might be seen by investors as a measure for
future investment growth for companies.

FDA also checks all the facilities and warehouse being used for the product
maintenance and storage. The agency publishes announcements of product
recalls in collaboration with companies and local partners. Such recalls can be the
result of undeclared ingredients in the contents, which can pose risks for consumers
with allergies. Contamination of products or the failure to handle the product
according to safety parameters can also be the cause for recalls.

Any imported regulated product must undergo or be tested by FDA before entering
any border of a country. (https://www.investopedia.com/terms/f/fda.asp, n.d.)

Before a company’s products are allowed entry into the Philippine market, each of
these products must undergo separate product registration processes. Depending
on the classification of the products to be marketed (food, food supplement, drug,
cosmetic, household hazardous, pesticides, medical device, diagnostics or
veterinary products), there are vastly different registration requirements and
respective processing timelines.

Requirements:

Accomplished and duly notarized application forms No.1 and No.8;

Copy of valid contract between manufacturer and

trader/distributor/seller/exporter/importer;

Copies of valid LTOs for manufacturer/trader/distributor/seller/exporter/importer;

 Unit dose and batch formulation (in metric system);

Technical specifications on all raw materials;

Certificate of Analysis on raw materials and finished product from manufacturer;

Technical specifications of finished product;

Master manufacturing procedure, production equipment, sampling and in-

process controls;
Assay on test procedures and data analysis (if applicable);

Stability study in accordance with the Philippine national guidelines and ASEAN
guidelines;

Representative sample of packaging and labelling materials for commercial

market;

Copy of ACB approval; and

Copy of the original Product Registration in the manufacturing country (for foreign
manufactured products).

Procedure:

1. Submit application and all requirements to Public Assistance Information and

Compliance Section of FDA for assessment;
2. Proceed to Accounting and Billing Department to have registration fees assessed
and paid for;
3. Obtain endorsement for Certificate of Registration after evaluation of Product
Services Division; and
4. Secure signed Certificate of Registration and Product Registration documents
from FDA.
For a company to be able to import, distribute, market, advertise or manufacture
their products here in the Philippines, they must first secure a License to Operate
(LTO) as Importer/Distributor/Wholesaler, for products imported from different
countries, or as Manufacturer, for locally manufactured products. After obtaining an
LTO companies may then proceed to apply for a Certificate of Product Registration
(CPR), which states that the product has been evaluated and officially registered
with the Philippine FDA.

Establishments under industries requiring a License to Operate as manufacturer,

importer, distributor, wholesaler, or exporter:

 Food
 Drugs
 Cosmetics
 Household Hazards
 Veterinary Products
 Medical Devices (to be submitted to the Department Of Health – Center for
Device, Regulation, Radiation Health and Research)
Requirements:
 Accomplished and duly notarized Petition Form and Joint Affidavit of
Undertaking;
 List of products to be distributed, identified by generic names and brand names
intended for use;
 Copies of Pharmacist Board Registration Certificate, PRC ID, valid PTR, ID
picture, and Duties and Responsibilities;
 Certificate of Attendance of owner or pharmacist to an FDA seminar on Licensing
of Drug Establishments;
 Certificate of Registration with SEC and Articles of Incorporation/Partnership (for
corporations or partnerships);
 Certificate of Business Name Registration with DTI (for single proprietorships);
 Locational plan and floor plan (office and storage room) with dimensions; and
 Contract of lease for the space to be occupied.
If Importer
 Foreign Agency Agreement (FAA) from each supplier, duly authenticated by the
Territorial Philippine Consulate
 Certificate of Registration of manufacturer and its conformity with the Good
Manufacturing Practices From Health Authority authenticated by the Philippine
Consulate
If Wholesaler
 Valid current contract with FDA licensed supplier/manufacturer
 Certificate of product registration from FDA
 Copy of LTO from supplier/manufacturer
If Exporter
 Valid current contract with FDA licensed supplier/manufacturer
 Certificate of product registration from FDA
 Copy of LTO from supplier/manufacturer
Requirements for verification during inspection:
 Reference materials:
o Philippine National Drug Formulary (latest edition)
o R.A. 3720: Foods, Drugs, Devices & Cosmetics Act
o R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and
Regulations
o R.A. 5921: Pharmacy Law as amended and Relevant Implementing Rules
and Regulations
o Latest edition of United State Pharmacopoeia/National Formulary (USP/NF),
or Remington’s Pharmaceutical Sciences, or Goodman & Gilman’s The
Pharmacological Basis of Therapeutics
 Batch Distribution Record Book
Procedure:
1. Submit application requirements to FDA;
2. Proceed with interview with the Food and Drug Registration Office (FDRO);
3. Review of completion of requirements and application by the Licensing
Department;
4. Receive Order for Payment and complete application;
5. Request for schedule of inspection;
6. Physical inspection of office and facility by the FDRO;
7. Approval of the LTO by the Director; and
8. Release of documents to applicant.
(https://www.tripleiconsulting.com/fda-license/, n.d.)

The hassle involved in procuring licenses and permits is a common problem

encountered by many companies looking to have their products introduced to the
Philippine market. This is a major issue raised by many small and medium
businesses in the country which has caught the attention of the Department of Trade
and Industry (DTI).

As a solution to this reoccurring problem, Department of Trade and

Industry suggested the Food and Drug Administration (FDA) and Negosyo Centers
to team up to and create a smoother and faster processing of the necessary permits
and licenses required.

The joint venture of these nationwide networks of government offices will

simplify the requirements and harmonize the time frame for the different applications
nationwide. Furthermore, and as mentioned in our previous post, FDA implemented
this month the new application process for companies looking to secure a License to
Operate (LTO) through the FDA electronic portal. Under the Food Safety Act of
2013, exporters, importers, traders,
manufacturers, wholesalers, and distributors of cosmetics, food, and health products
must secure a license to operate and certificate of product registration for each
product to ensure the safety and quality of the product (Victor Viana, Client Sales
Manager, Triple i Consulting).

Foreign investors and enterprises that intend to do business in the Food,

Pharmaceutical or Cosmeceutical industries in the Philippines are required to
register their products with the Food and Drug Administration (FDA). The registration
requirements and processing timelines depend on the classification of the products
to be marketed, which could be any of the following: food, food supplements, drugs,
cosmetics, household hazardous, pesticides, medical devices, diagnostics, or
veterinary products.

Before these products can be imported, exported, distributed, marketed,

advertised or manufactured in and out of the Philippines, a foreign investor or
company must first secure a License to Operate (LTO) from the FDA as: (1)
Importer, Distributor or Wholesaler if their products are going to be imported from
different countries; or as (2) Manufacturer if their products are going to be
manufactured locally.

After obtaining an LTO, they must apply for a Certificate of Product

Registration (CPR) to have their products examined and officially registered with the
FDA. Product licensing and certification from the FDA is required by law under
Republic Act No. 10611 and is strictly regulated.
 The FDA is tasked to regulate the production, sale, and traffic of products
allowed entry into the Philippine market to protect public health and safety, and it is
important to secure LTO and CPR from this agency not only to comply with
Philippine laws but also to increase the credibility of your product/s through the
assurance of food safety and ethical practice in the medical trade. (KittelsonCarpo
Consulting, n.d.)https://philippinesbusinessregistration.com/fda-registration-services/

Certificate of Product Registration (CPR) Application process:

Step 1. Proceed for the Issuance of Center for Food Center for Cosmetics Center
for Drug Center for Medical Device;

Step 2. Proceed for Issuance;

Step 3. Proceed for Payment;

Step 4. Proceed for Submission of (Hardcopy and E-copy requirements);

Step 5. Technical Evaluation (refer to Citizen’s Charter for the processing time);

Step 6. Proceed for the release of CPR. Retrieved from

(https://ww2.fda.gov.ph/attachments/article/17112/LTO%20and%20CPR%20App%2
0Process%20Flowchart.pdf, n.d.)

The application will be reviewed and evaluated if in accordance with the

requirements. All complying applications will be issued a certificate of product
registration. All non-complying applications will be issued a notice of deficiency.
Each company is given a non-extendable ninety (90) days compliance period. All
those who will not be able to comply will be disapproved but will be given a period of
sixty (60) days to file for re-application and comply with all the deficiencies. In case
after this period the application did not satisfactory comply all the requirements, the
application will be disapproved and the company needs to file for initial application.
 The BHDT is the recommending office for approval of the CPR. All CPRs are
forwarded to FDA (BFAD) for approval. (https://www.doh.gov.ph/node/1236, n.d.)

The U.S. FDA does not “approve” food products. However, there are many
FDA regulations to familiarize yourself with before you begin production and
distribution. For one, you need to register with FDA. Secondly, FDA’s labelling
requirements are very strict and extensive. Labeling mistakes are one of the most
common mistakes made with FDA regulations, so it’s a good idea to have your label
design looked over by a professional before printing and applying them to your
products. Thirdly, you’ll always need to familiarize yourself with FDA’s Current Good
Manufacturing Practices (CGMPs) and make sure to abide by them, as FDA can
inspect your facility at any time.

Registrar Corp (U.S. FDA Regulatory Requirements) is an FDA compliance

firm located in Hampton, Virginia. Retrieved (from https://www.quora.com/How-do-I-
get-a-product-to-be-approved-by-the-FDA, n.d.)

Bringing Regulated Products for Personal use into the Philippines - (Per Joint
Circular No. 1 dated 22 June 2015 of the Department of Health, Food and Drug
Administration, and the Bureau of Customs), accessed in Nov 2017.

Regulated products - Philippine authorities consider the following items

as Regulated Products which travellers may bring into the Philippines without prior
clearance from the Food and Drug Administration (FDA) only in limited quantities
and on the conditions that the items: :
 are for personal use only
 do not exceed the quantity indicated below
 are brought into the Philippines either (a) in the traveler’s personal baggage, (b)
in a balikbayan box, or (c) in parcel sent through mail or delivery service
The regulated products and respective quantity limitations are as follows:
1. Assorted cosmetics: 5 kilograms
2. Bar soap: 2 kilograms comprising different variants (only up to 500 grams of the
same variant allowed)
3. Childcare articles: 5 kilograms
4. Household hazardous substances (detergent: fabric conditioner: fabric softener:
dishwashing liquid): 5 kilograms
5. Insulin needles and lancets: up to 100 pieces
6. In-vitro diagnostic products: 1 piece of each type
7. In-vitro maintenance test strips: up to 100 pieces
8. Lipstick: 10 pieces comprising different variants (only up to 3 pieces of the same
variant allowed)
9. Lotion: 2 kilograms comprising different variants (only up to 1 kilogram of the
same variant allowed)
10. Medical devices: 1 piece of each type
11. Over-the-counter drugs: 50 grams
12. Perfumes: 5 pieces
13. Prescription drugs, quantity or volume indicated in physician’s prescription
(actual prescription must be presented, indicating physician’s license or practice
number)
14. Processed food (including cooked food): up to 10 kilograms
15. Shampoo: 2 kilograms
16. Toys: 10 pieces of different variants (only up to 2 pieces of the same variant
allowed)
17. Vitamins: supplements: health supplements intended as maintenance medicine:
500 grams total
18. Wines, liquor: 2 bottles, but not exceeding 1.5 liters
Any quantity of the above-cited products, whether declared or undeclared, beyond
the specified limits which do not have the required Bureau of Customs or FDA-DOH
(Food and Drug Administration – Department of Health) Clearance, will be seized
and forfeited by the Bureau of Customs.
CHAPTER 3

METHODOLOGY

Research Design

In this study, the researchers would utilize qualitative and quantitative

research. The qualitative research would apply to gather information and data of the
individual opinion of the respondents that give the researchers an understanding
about the problem regarding the delay to the warehouse. This is an opportunity for
the researcher to ask questions relating to the topic by means of conducting an
interview.

Respondents of the Study

The respondents of the study are personnel or staff of the different alcoholic
and non – alcoholic companies

Data Gathering

The analysis of utilized auxiliary data gathered and promptly accessible from
the interviewee which are likewise gathered after the interview. The researchers will
use this technique of content analysis, which is used as research technique that
creates acceptable inferences by analyzing and decoding textual material. This
study will be maximizing to deliberate and interpret the data which is gathered.
Ethical Consideration

The proper guidelines of ethics in research are very important. With regard to
ethical aspects of research, the respondent’s identity will be based upon them, if
they are not willing to disclose their identity, their identity will not be exhibited. Full
consent should be obtained from the respondents that their given data will be used
only for research purpose. The researchers should strictly protect the privacy of the
data given by the respondents. The respondents will have to participate by their own
free will and not by force. Also the researchers should approach the respondents in
a polite way to avoid disrespect. The researchers should not fabricate the given
data. Hence, the ethical aspects of research will be followed strictly in this research.