Professional Documents
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Article I – General Policy……………………………………………………………… 4
Section 1. Composition……………………………………………………… 9
1.1 Command Group
1.2 Secretariat
1.3 Staff
1.4 Task Group Cluster/STG D-PUNCH
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Article V – Handling, Custody and Disposition of Evidence……………………. 19
Section 1. Procedures……………………………………………………….19
Section 5. Destruction……………………………………………………… 22
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FOOD AND DRUG ADMINISTRATION-PHILIPPINE NATIONAL POLICE
IMPLEMENTING RULES AND OPERATIONAL GUIDELINES ON THE
MEMORANDUM OF AGREEMENT DATED NOVEMBER 28, 2016
WHEREAS, the Food and Drug Administration (“FDA” for brevity) is mandated by
law to establish standards and regulations and to adopt measures to ensure pure, safe,
efficacious and good quality drugs in the country as well as pure, safe and quality foods,
health products, medical devices and equipment and the regulation of household
hazardous substances;
WHEREAS, under Section 15, Article II of the 1987 Constitution of the Republic of
the Philippines, it is the policy of the State to “protect and promote the right to health of
the people and instill health consciousness among them”, and Section 12, Article XIII of
the aforesaid Constitution provides that, “The State shall establish and maintain an
effective food and drug regulatory system and undertake appropriate health manpower
development and research, responsive to the country’s health needs and problems”;
WHEREAS, Republic Act No. 9711, otherwise known as the “Food and Drug
Administration Act of 2009”, has declared that it is a policy of the State to adopt, support,
establish, institutionalize, improve and maintain structures, processes, mechanisms and
initiatives that are aimed, directed and designed to: a) protect and promote the right to
health of the Filipino people; and b) help establish and maintain an effective health
products system regulatory
WHEREAS, the FDA, in its campaign against the proliferation of illegal drugs and
substances, counterfeits, unregistered, adulterated, misbranded health products in the
country, needs the assistance of the law enforcement authorities particularly the PNP,
for the effective implementation of the provisions of RA No. 3720, as amended by EO
No. 175 and further amended by RA No. 9711, RA No. 8203, RA No. 9502, RA No.
10611 and all the other FDA-implemented laws, rules and regulations;
WHEREAS, pursuant to the afore-cited provision of Republic Act No. 9711, the
FDA and the PNP entered into a Memorandum of Agreement (“FDA-PNP MOA” for
brevity) last November 28, 2016 wherein the PNP members deputized and specifically
authorized by the FDA shall assist the FDA in the enforcement of its regulatory and
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monitoring functions pursuant and subject to the pertinent provisions of RA No. 9711, its
implementing rules and regulations.
ARTICLE I
GENERAL POLICY
Section 1 – Purpose
These Rules and Regulations provide for the rules to be followed by, including the
duties and responsibilities of all PNP members deputized and specifically authorized by
the FDA to enforce RA No. 3720, as amended by EO No.175 and further amended by
RA No. 9711, RA No.8203, RA No.9502, RA No. 10611 and all the other FDA-
implemented laws, rules and regulations.
These Rules and Regulations implementing the FDA-PNP MOA, shall apply to all
members of the FDA-PNP Taskforce “D-PUNCH” deputized and specifically authorized
by the FDA to enforce RA No. 3720, as amended by EO No. 175 and further amended
by RA No. 9711, RA No. 8203, RA No. 9502, RA No. 10611 and all the other FDA-
implemented laws, rules and regulations.
FDA-PNP Task Force “D-PUNCH” shall be governed by the following Vision and
Mission:
Vision
Mission
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Awareness Aspire to achieve an overall awareness to the public protecting them
from unqualified and substandard form of health products circulating
in the country
In the absence of any applicable provisions in these rules and regulations the
pertinent provisions in Book VII (Administrative Procedure) of Executive Order No. 292
or the Administrative Code of 1987, Executive Order No. 26 series of 1992 or the Rules
of Court shall have suppletory application.
ARTICLE II
DEFINITION OF TERMS
For purposes of these Rules and Regulations the definition of terms in the FDA-
PNP MOA is hereby adopted. In addition: (Annex A: Definition of Terms)
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5. Case Operation Plan (COPLAN) – a time phase plan of action under an
intelligence project directed to specific personalities/organization, crime group,
through infiltration and penetration by action agents with the ultimate objective of
neutralizing the target personalities.
6. Conflict of Interests – All covered FDA and PNP members or operatives having
conflict of interest, such as but not limited to:
Above enumerated are hereby tasked to declare the conflict of interest and to take
appropriate action to suppress the conflict.
8. Devices – means medical devices, radiation devices and health related devices.
c. “Health-related Device” means any device not directly used in health care but
has been determined by the FDA to adversely affect the health of the people.
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9. Drugs - means any of the following:
c. Articles (other than food) intended to affect the structure of any function of the
body of human beings or animals; or
10. FDA Cases – refer to cases brought about by violations of the provisions of RA
No. 3720, as amended by EO No. 175 and further amended by RA No. 9711, RA
No. 8203, RA No. 9502, RA No. 10611 and all the other FDA-implemented laws,
rules and regulations.
11. FDA Officials/Employees shall mean officials and employees of the FDA who
are incumbent to a position regardless of whether permanent, casual, or
contractual subject to the rules on exclusion provided in this Order, including
those validly deputized to perform FDA functions, duties and responsibilities.
12. FDA Personnel Order (FPO) – issuance directed to FDA offices, officials,
employees, or group of persons, including those validly deputized concerning
specific matters including assignments, re-assignments, detail, transfer,
secondment; attendance to conferences, training, workshops, meetings, seminars
and other government sponsored activities on official business or time; delegation
of authority to subordinate officials, creation of committees, technical working
group (TWG), Task force even with the participation of external experts or persons
and all movements of personnel for compliance of all concerned. It has identifiable
targets usually for a certain period of time.
13. FDA-PNP Examiner- refers to the PNP chemist/analyst deputized by the FDA to
conduct product analysis or verification or coordination regarding the conduct of
product analysis or verification pertaining to violations of FDA-implemented laws
and regulations.
14. FDA-PNP Task Force “D-PUNCH”– refers to the task force composed of both
the FDA and PNP officers mandated to spearhead the collective effort to ensure
the enforcement of FDA laws and regulations.
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15. FDA-PNP Task Force “D-PUNCH” Secretariat – refers to the Office from both
the FDA and PNP, which shall provide administrative and technical support to the
Task Force;
16. FDA-PNP Task Force “D-PUNCH” Investigator – refers to the PNP investigator
deputized by the FDA and FDA-identified officers specifically authorized to
conduct case build-up on FDA cases.
17. FDA-PNP Task Force “D-PUNCH” Operative – refers to the PNP operative
deputized by the FDA and FDA-identified officers specifically authorized to
conduct operations pertaining to violations of FDA laws and regulations.
18. Food - means any processed substance, which is intended for human
consumption and includes drinks for human beings, beverages, chewing gum and
any substances, which have been used as an ingredient in the manufacture,
preparation or treatment of food.
19. Health Products - means food, drugs, cosmetics, devices, biologicals, vaccines,
in-vitro diagnostic reagents and household/urban hazardous substances and/or a
combination of and/or a derivative thereof. It shall also refer to products that may
have an effect on health which require regulations as determined by the FDA.
20. High Risk – denotes to a case or situation that is subject or exposed to a danger
or difficulty in operating. The danger or difficulty may be by any or all of the
following factors: Personality, Area, Activity, Products.
21. Legal Action shall mean action, suit or proceeding whether criminal, civil or
administrative in nature, filed against FDA Officials/Employees in connection with
the lawful exercise of their official functions, duties or responsibilities as such.
22. Legal Assistance- refers to the provision of legal fund which shall cover the cost
of suit and Attorney’s fee as mentioned in section 4.5 of article VII.
24. Legal Fund refers to the amount out of the total interest earned from the retained
income gained every calendar year by the Food and Drug Administration net of
withholding tax.
25. PNP Operational Procedure (POP) – pertains to the set of rules, policies,
guidelines and procedures to be observed in the conduct of police operations
26. Team Leader – a responsible Police Commission Officer with a rank of at least
Police Inspector who leads and take responsibility in the conduct of operation.
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ARTICLE III
ORGANIZATIONAL STRUCTURE: FDA-PNP Task Force “D-PUNCH”
Section 1 – Composition
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Sub Task Group Leader BC, DPSB
Asst. STGL TL, CIDT
Tactical Team DPSB
Inves/Intell CIDT/DPSB
Technical Support Team CLO, ACG
Legal LS
FDA Representative
Members:
c. File criminal case in any court or tribunal upon the prior approval
by the FDA Director General. The approval of the institution of a
criminal prosecution against the offender shall be accompanied by
a certification certifying the facts to the Secretary of Justice,
through the Secretary of Health, together with the laboratory
report, the findings of the FDA and PNP, or other documentary
evidence on which the charge is based.
d. Seize health products pursuant to orders; or
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e. Padlock establishments pursuant to orders of the FDA or any court
or tribunal;
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2.3. Staff Functions
2.4. Functions of Task Group Clusters (NL, SL, Vis, EM, WM, and
NCRPO)
f. Intelligence production
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b. Review and evaluate the application for completeness in form and
in substance.
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d. After Operations Report – to submitted after the completion of the
operations
e. Development Report – result of case monitoring containing the
details and development of the case until the verdict or decision is
made.
5.3. The designated Team Leader must determine the number of agents
he/she will need to successfully implement the FDA-related operations,
provided that an FDA officer and member of the taskforce shall always
be included. In choosing his members, the following shall be considered:
a. Expertise;
b. Experience;
c. Technical Aptitude.
5.4. The Team Leader shall secure, through the FDA-PNP Taskforce
Secretariat the required FDA Personnel Order identifying the team
members and the scope of their operation.
5.5. The Team Leader shall, prior to the actual operations, conduct a detailed
briefing for the operating personnel. Charts, photographs, maps, etc.,
should be used as necessary and the specific duties and responsibilities
of each member, clearly discussed.
5.6. The Team Leader, in coordination with the assigned Legal Officer should
see to it that appropriate warrant/s are obtained when necessary.
5.8. The Team Leader must also designate an investigator who shall keep
and preserve notes to record the actual conduct of the operation
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including valuable information that can be used in the prosecution of the
case or in the conduct of future operations.
5.9. All operating Units shall designate a “Seizing Officer” who shall be
responsible for taking into custody all violative health products and non-
drug evidence during the operation to ensure that all these evidences
are safe and handled in accordance with applicable law, rules and
regulations.
5.10. The Team Leader shall secure, through the FDA-PNP Taskforce “D-
PUNCH” Secretariat, the required certification from the FDA prior to filing
of the case.
6.3. In any operation, the Team Leader must see to it that all actions are in
accordance with the law, the crime-scene is preserved and well-
managed, the suspects are arrested, all possible evidence are taken into
custody and that the safety of operating elements and innocent people in
the area of operations are ensured.
6.5. Task Force Investigator shall maintain a record of the events, which
include among others, jump-off time and date, name of the Team
Leader, area/s of operation and vehicles used. A record book shall be
preserved for the purpose and shall form part of the documents covering
the operation.
6.6. Upon arrival in the area of operation, immediate area observation and
assessment must be conducted by the Team Leader and last minute
instructions to be given, as necessary.
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6.8. Any arrested suspect shall be apprised of his/her CONSTITUTIONAL
RIGHTS (I/We are Police Officers. I/we are arresting you for violation of
RA __________ (FDA Law). You are hereby informed that you have the
right to remain silent. Anything that you say, can and will be used for or
against you in any Court of Law. You have the right to a counsel of your
own choice and if you cannot afford one, you shall be provided with a
counsel to assist you. You can waive all this rights in the presence of a
Lawyer and in writing. Do you understand these rights?)
6.10. The Team Leader must see to it that all pieces of evidence from the
suspect/s or those found in the area of operation are handled in
accordance with the standardized pro-forma Forms established in this
these Guidelines. Search warrant, inventory report, cer of peaceful and
orderly search, arrest report, affidavit, SMS, spot report, after operation
report, complaints – search this forms.
6.11. Upon return of the operating personnel to their Station, the Task Force
Investigator must record the time and date of return, name/s of the
arrested person/s, and other significant circumstances that transpired
during the operation.
ARTICLE IV
SYSTEM AND PROCEDURE
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validation and investigation. Upon approval, the Secretariat shall
assign the case to the concerned FDA-PNP Task Group Cluster
which shall effect an investigation and other appropriate intervention.
The Sub-Task Group Commander shall assign a FDA-PNP
Taskforce investigator or operative and shall inform the secretariat
the results thereof.;
1.2 Operation:
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seizure of said health products, as well as, labelling, other relevant
documents, or machine, other equipment and vehicles used to
perpetrate the offense or illegal activities.
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2.2 Operation:
Article V
HANDLING, CUSTODY AND DISPOSITION OF EVIDENCE
Section 1 – Procedures
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1.1 During handling, custody and disposition of evidence, provisions of all
applicable laws and its IRR shall be strictly observed.
1.3 The Seizing Officer must mark the evidence with his initials indicating
therein the date, time and place where the evidence was found/recovered
or seized.
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2.3 For warrantless seizures like buy-bust operations, inventory and taking
of photographs should be done at the nearest Police Station or Office of
the apprehending Officer or Team.
2.5 Within the same period, the Seizing/ Inventory Officer shall prepare a list
of inventory receipt of confiscation/ seizure, to include but not limited to,
the following:
c. Identity of the Seizing Officer and all persons who witnessed the
operations.
2.6 Within 24 hours upon confiscation/ seizure when practicable, all health
products, containers, packaging, labelling, equipment, etc. shall be
submitted to the FDA-PNP Taskforce “D-PUNCH” for proper disposition.
2.8 The Seizing Officer shall properly accomplish the Chain of Custody Form
and turn it over including the evidence to the Investigator-On-Case for
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submission to the FDA Laboratory or PNP Crime Laboratory or FDA
Center as the case may be.
4.1 The Seizing Officer must preserve the integrity and evidentiary value of
the pieces of evidence.
4.2 Persons handling health product evidence from the time of its
seizure/confiscation should be limited to the Seizing Officer, the
Investigator-On-Case and FDA Laboratory or PNP Crime Laboratory or
FDA Center personnel. All non-health product evidence shall be turned-
over to the evidence custodian.
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4.3 An acknowledgement receipt shall be issued by the person receiving the
evidence. Such receipt shall form part of the case folder of the
transmitting Unit.
4.4 The Seizing Officer shall accomplish the Chain of Custody Form and with
it, submits the evidence to the FDA Laboratory or PNP Crime Laboratory
or FDA Center, as the case may be, for examination or verification.
Section 5 – Destruction
a. After filing of the case, the Food and Drug Administration (FDA) shall,
within seventy-two (72) hours, conduct an ocular inspection of the
confiscated, seized and/or surrendered violative health products or
hazardous health products.
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2) Other lawful appropriate methods as may be authorized by the
DOH, in consultation with DENR.
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n. In cases of seizure where no person is apprehended and no criminal
case is filed, the FDA may order the immediate destruction or burning
or disposal of seized violative health products or hazardous health
products: Provided that appropriate inventory of health products, in
the presence of witnesses, laboratory examination and prescribed
reports have been carried out. Such destruction shall be made in the
presence of prescribed witnesses. The FDA officer-in-charge of
destruction through the Task Force Secretariat shall issue a sworn
certification as to the fact of destruction or burning.
Article VI
Common Provisions
Section 2 In accordance with R.A. 9711, and its Implementing Rules and Regulations,
and other relevant laws, the seized article or articles of food, device, cosmetics,
household hazardous substances and health products that are adulterated,
counterfeited, misbranded or unregistered; or any drug, in-vitro diagnostic reagents,
biologicals, and vaccine that is adulterated or misbranded, by virtue of operation
conducted pursuant to these Operational Guidelines, shall be under the control,
possession and custody of the FDA. The FDA-PNP Task Force “D-PUNCH” shall
provide for the warehouse for seized health products in every Region;
Section 3 All case build up and operations shall be covered by separate FDA
Personnel Orders duly approved and signed by the Director General, FDA.
Section 4 FDA-PNP Task Force “D-PUNCH investigators and operatives shall act as
witness and testify in Court, or when called upon before the FDA, performing its quasi-
judicial function, for the speedy prosecution of criminal complaints against violators of
FDA-implemented health laws, rules and regulations.
Section 5 FDA-PNP Task Force “D-PUNCH” shall jointly conduct quarterly consultative
meeting, or as often as necessary, to discuss and tackle, among others, various issues
and concerns, necessary policy-directives and updates on FDA cases;
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Section 6 Other stakeholders may be invited during the consultative meeting to provide
assistance to the FDA-PNP Task Force “D-PUNCH”.
Article VII
Legal Assistance
Members:
(1) Sub-Task Group Concerned
(1) TG Cluster
(1) FDA Representative
Section 2 – Scope
These rules shall govern the use of legal fund established out of the interest
earned from the retained income of the Food and Drug Administration. Additionally, a
portion of the fund transferred to the PNP may be used to cover legal assistance.
The legal assistance shall cover the cost of suit and attorney’s fees reasonably
incurred by the FDA officials and employees in connection with any criminal, civil or
administrative action or proceeding, to which they may be, or have been made, a party
by reason of the performance of their functions and duties. Notwithstanding, it is subject
to prohibitions, restrictions, exceptions, or limitations as stipulated below or as may be
provided by law rules and regulations.
Section 3 – Exclusion
The legal fund for the legal assistance shall not cover:
3.2 FDA official or employee whose services to the FDA has been severed or
otherwise terminated by the FDA for any legal cause except compulsory
retirement;
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3.3 The FDA Officials/Employees is found, with finality, criminally, civilly or
administratively liable for the crime or offense charged subject to the rule
on paragraph 5.1.5 of Rule V below
3.4 Any action or suit filed against the FDA Officials/Employees who is
already entitled similar entitlement provided under any other laws, rules
and regulations;
3.5 Any action that is to be handled by the Office of the Solicitor General; or
3.6 Such other justifiable cause as determined by the head of the agency.
4.1. The following rules and regulations shall govern the establishment and
administration of the legal fund and legal assistance in the FDA.
b. FDA shall provide the legal assistance fund in favor of any member of
the Task Force “D-PUNCH” who will be charged with criminal, civil or
administrative case in the performance of his/her duty.
a. Upon receipt of notice that any legal action, suit or proceeding is filed
against him/her in the exercise of their official functions, the taskforce
member shall notify the Secretariat in writing of such action, suit or
proceeding;
b. The task force member shall signify his/her intention to avail of the
fund and assistance and secure the approval of the FDA Director
General on the terms and conditions of the engagement of counsel
for the purpose of entitlement to the legal fund;
d. Upon finding that all the requirements have been fully complied with
and that all the necessary documents submitted are in order, the
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Legal Assistance Board shall then recommend the processing of the
claims, and the subsequent release of funds for consideration of the
FDA Director General. The Director General can exercise prerogative
on whether to grant or deny the request for legal assistance.
h. Any approved legal fund or assistance to the claiming task force that are yet
to be released may continue until any of the applicable conditions in the
Exclusion above becomes present or is otherwise suspended pursuant to
Item 4.5 below.
4.3. Duties and Responsibilities of Task Force Member Availing the Legal
Fund
a. The task force member shall ascertain and disclose in writing to the
Legal Assistance Board that the private lawyer or law firm engaged or
to be engaged is not connected or related to any FDA regulated
establishment, including related foundations, to avoid impropriety and
conflict of interest. In the event that it should come to the knowledge
of the FDA official or employee that the lawyer/firm so engaged is
connected or related to any FDA regulated establishment including
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related foundations, such fact should be disclosed immediately to the
head of the agency for appropriate decision.
b. The private lawyer, special counsel or law firm to represent the FDA
official or employee shall disclose in writing to the FDA that the former
is not connected or related to any FDA regulated establishment,
including related foundations, to avoid impropriety and conflict of
interest.
a. The legal assistance shall cover the cost of suit and attorney’s fees
not to exceed the schedule of fees issued by the Supreme Court.
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b. Provided that all the above expenses arising from the suit or
proceeding shall not exceed the total amount of Php250,000.00.
(maximum).
The release of the legal fund to the task force member may be
suspended anytime by the head of the agency for just cause. Non-compliance
by the official or employee of his/her obligation or nonfulfillment of the private
lawyer or special counsel of his qualification, duties or responsibilities of the
member as mandated in these rules may be construed as just cause.
ARTICLE VIII
FINAL PROVISIONS
_____________________________ _____________________________
Nela Charade G. Puno PDG Ronald M. De la Rosa
Director-General Chief, PNP
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