RA 9165 Flashcards
Republic Act No. 8203
Special Law on Counterfeit Drugs
Special Law on Counterfeit Drugs: Enacted on _______
06 September 1996
Special Law on Counterfeit Drugs:
Effective on _______
27 October 1996
Generally prohibits activities related to the importation, manufacture, sale, distribution or mere possession of “counterfeit drugs”
Republic Act No. 8203
Counterfeit drug
● Wrong ingredients
● Correct ingredients but insufficient in quantity
● No active ingredients
● Fake packaging
- bearing without authorization registered in the BPTTT
- refilled in containers by unauthorized persons
- unregistered imported drug product
- no amount or different active ingredient or less than 80% of the active ingredient
- deliberately and fraudulently mislabeled
Due to these discrepancies, there is a reduction of the drug’s ________
drug’s safety, efficacy, quality, strength, or purity
Bearing without authorization the trademark, trade name or other identification mark or imprint or any
likeness to that which is owned or registered in the ________ in the name of another natural or juridical person
Bureau of Patent,
Trademark and Technology Transfer
(BPTTT)
______ in containers by unauthorized persons if the legitimate labels or marks are used
Refilled
An _______imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records
unregistered
A drug which contains _______ of or a ______ active ingredient or less than ________of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss of efficacy due to
expiration
no amount; different; eighty percent (80%)
A drug which is ___________ with respect to identity and/or source with fake packaging, and can apply to both branded and generic products
deliberately and fraudulently mislabeled
Possession of any such counterfeit drugs. However, any person found in possession of counterfeit drugs, in violation of this subsection, shall be exempted from liability under the provisions of this Act after
(SEC 4, PROHIBITED ACTS)
- presentation of sales invoices, official receipts or other legally acceptable documents
- presentation of certificates and other documents evidencing the importation or exportation of the
counterfeit drugs
Forging, counterfeiting, simulating or falsely representing, or without proper authority, using any ____________________________________________________ authorized or required by Republic Act No. 3720 (FDA), as amended, and/or the regulations promulgated under this Act;
(SEC 4, PROHIBITED ACTS)
mark, stamp, tag, label or other identification mark or device
____________________________________
lawfully belonging to another person, for the purpose of using such label or a part thereof on any counterfeit drug: Provided, That if the person who committed any of the acts enumerated in
(SEC 4, PROHIBITED ACTS)
- Photocopying, duplicating, altering, printing, transferring,
obliterating or removing the approved label or any part thereof
______________________________________________________________ or reproduce the trademark, trade name or other identifying mark of another registered producer or any likeness thereof, upon 4 any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade
name
(SEC 4, PROHIBITED ACTS)
- Making, selling, or concealing any punch, dye, plate or any
other equipment or instrument designed to print, imprint
SEC 5, PARTIES LIABLE
- manufacturer, exporter or importer of the counterfeit drugs and their agents
- seller, distributor, trafficker, broker or donor and their agents
- possessor of counterfeit drugs
- manager, operator, or lessee of the laboratory or laboratory facilities
- owner, proprietor, administrator, or manager
- registered pharmacist
- juridical person
SEC 7, ADMINISTRATIVE SANCTIONS
- Permanent closure and revocation of its license to business
- not less than One hundred thousand pesos (P100,000) not more than Five hundred thousand pesos (P500,000)
- forfeiture, confiscation, and destruction of products
- cancellation of professional license
- Filing of criminal charges against the violator
- Permanent disqualification from owning or operating an establishment
SEC 8. PENALTIES
for mere possession of counterfeit drugs (1)
Imprisonment of not less than six (6) months and one (1) day; but not more than six (6) years
for mere possession of counterfeit drugs (2)
- Imprisonment of six (6) years and one (1) day, but not more than ten (10) years
- not less than One hundred thousand pesos (P100,000) but not more than Five hundred thousand pesos (P500,000)
if the counterfeit drug is intended for animals; or (Vet meds)
Imprisonment of not less than six (6) months and one (1) day, but not more than two (2) years and four (4) months
for any manufacturer, seller or distributor who shall conceal, substitute, dispose or destroy any drug as may have been segregated and sealed by the Bureau
Imprisonment of not less than six (6) years and one (1) day but not more than ten (10) years
use of the drug found to be counterfeit, the
illness sought to be cured is aggravated or physical injury or
suffering results therefrom,
a punishment of imprisonment from
twelve (12) years to fifteen (15) years and a fine ranging from One hundred thousand pesos (P100,000) to Five hundred thousand pesos (P500,000) shall be meted out
counterfeit drug be the proximate cause of death of a victim, who unknowingly purchased and took a counterfeit drug
penalty of life imprisonment and a fine of Five hundred
thousand pesos (P500,000) to Five million pesos (P5,000,000)
shall be imposed
Declaring the 3rd week of November of every year as the
“National Consciousness Week Against Counterfeit Medicine
(NCWACM)”
PRESIDENTIAL PROCLAMATION NO. 2082
“National Consciousness Week Against Counterfeit Medicine
(NCWACM)
3rd week of November of every year
Mandated different government agencies in collaboration with private sectors in leading activities that will raise public
awareness about the dangerous effects to health of using
counterfeit medicine
PRESIDENTIAL PROCLAMATION NO. 2082
Rule IV: Procedure in the Filing of Administrative Complaint
- MAH/Brand Owner Affidavit of complaint
- Consumer or Prescriber (doctor) Letter of complaint
(Submitted together with samples)
MAH/Brand owner
affidavit of complaint
Consumer or Prescriber
Letter of complaint
CONTENTS OF THE AFFIDAVIT OF COMPLAINT
- Name of the product, the lot numbers and expiry date
- Name and address of the person and/or drug establishment
- Specific acts
- Remedy or relief or action he shall intend FDA to take
(Shall be accompanied by the samples of suspected drug products duly marked for identification purposes)
Contents of the letter of complaint
- name of suspected product
- source or the name and address
- mode of acquisition
- reason or fact
(Shall be accompanied by the samples of suspected drug products duly marked for identification purposes)
RA 9165
“Comprehensive Dangerous Drugs Act of 2002”
An act instituting the comprehensive dangerous drugs act of 2002, repealing RA no. _____, otherwise known as the dangerous drugs act of 1972, as amended providing funds therefore and for other purposes
6425
shall be the policy-making and strategy-formulating body in the planning and formulation of policies and programs on drug prevention and control
The Dangerous Drugs Board
the DDB shall be under the office of the ________
President
The Board shall be composed of _________ members wherein _______ of which are permanent members, the other _______ members shall be in an ex officio (old official members) capacity and the ___ shall be regular
members
seventeen (17); three (3); twelve (12); two (2)
To carry out the provisions of this Act, the _______, which serves as the implementing arm of the Board
PDEA
responsible for the efficient and effective law enforcement of all the provisions on any dangerous drug
and/or controlled precursor and essential chemicals
PDEA
The PDEA shall be headed by a ___________ with the rank of
Undersecretary, who shall be responsible for the general administration and management of the Agency
Director General
Director general is appointed by the _____________
President of the Philippines
Director general is assisted by two (2) deputies Director General with the rank of _____________
Assistant Secretary
drug law enforcement, control and prevention campaign with the assistance of concerned government agencies;
● with ____ and ____
(Powers and Duties of the PDEA)
DOH and FDA
Establish ______ laboratories in each _____ office in every province and city in order to facilitate action on seized or confiscated drugs, thereby hastening its destruction without delay;
(Powers and Duties of the PDEA)
forensic; PNP
Recommend to the __________ the forfeiture of properties and other assets of persons and/or corporations found to be violating the provisions of this Act and in accordance with the pertinent provisions of the _______;
(Powers and Duties of the PDEA)
DOJ (Department of Justice); Anti-Money-Laundering Act of 2001
Conduct eradication programs to destroy _________ from which dangerous drugs may be extracted;
(Powers and Duties of the PDEA)
wild or illegal growth of
plants
Monitor and if warranted by circumstances, in coordination with the _________ and the _________, inspect all air cargo packages, parcels and mails in the central post office, which appear from the package and address itself to be a possible importation of dangerous drugs and/or controlled precursors and essential chemicals, through on-line or cyber shops via the internet or cyberspace;
(Powers and Duties of the PDEA)
Philippine Postal Office and Bureau of Customs
Establish and maintain a national drug intelligence system in cooperation with law enforcement agencies, other government agencies/offices and local government units that will assist in its apprehension of big-time drug lords;
● such as ________
(Powers and Duties of the PDEA)
NBI, PNP
Under the law, those caught importing, selling, manufacturing, and using illegal drugs and its forms may be fined and imprisoned for at least __________ to a lifetime, depending on the severity of the crime
(UNLAWFUL ACTS AND PENALTIES)
12 years
The penalty of ___________ and a fine ranging from __________ shall be imposed upon any person, who, unless authorized by law, shall import or bring into the Philippines any dangerous drug, regardless of the quantity and purity involved, including any and all species of opium poppy or any part thereof or substances derived therefrom even for floral, decorative and culinary purposes.
(UNLAWFUL ACTS AND PENALTIES)
life imprisonment to death; Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00)
The penalty of imprisonment ranging from ___________ to ___________; and a fine ranging from ______________ shall be imposed upon any person, who, unless authorized by law, shall import any controlled precursor and essential chemical.
(UNLAWFUL ACTS AND PENALTIES)
twelve (12) years and one (1) day to twenty (20) years; One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00)
The maximum penalty provided for under this Section shall be imposed upon any person, who organizes, manages or acts as a ________________ of any of the illegal activities prescribed in this Section.
(UNLAWFUL ACTS AND PENALTIES)
“financier”
The penalty of __________ to ________years of imprisonment and a fine ranging from _______________ to __________shall be imposed upon any person, who acts as a protector/coddler of any violator of the provisions under this Section.
twelve (12) years and one (1) day to twenty (20); One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00)
The penalty of___________ and a fine ranging from _____________ to _____________shall be imposed upon any person, who, unless authorized by law, shall sell, trade, administer, dispense, deliver, give away to another, distribute, dispatch in transit or transport any dangerous drug, including any and all species of opium poppy regardless of the quantity and purity involved, or shall act as a broker in any of such transactions.
life imprisonment to death ; Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00)
The penalty of imprisonment ranging from ___________ to __________ years and a fine ranging from ___________ to _____________shall be imposed upon any person, who, unless authorized by law, shall sell, trade, administer, dispense, deliver, give away to another, distribute, dispatch in transit or transport any controlled precursor and essential chemical, or shall act as a broker in such transactions.
twelve (12) years and one (1) day to twenty (20); One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00)
Unnecessary prescription of dangerous drugs
- 12 to 20 years
- 100k-500k
- revocation of license
Unlawful prescription of dangerous drugs
- penalty of life imprisonment
- 500k - 10M
S-1
Retail
Distributor /
Dispenser
(controlled chemicals)
S-2
Prescriber
S-4
Wholesale
distributor
S-3
Retail
distributor/
Dispenser
(dangerous drugs)
S-5-C
Manufacturer
S-5-I
Importer
S-6 Or P-6
Research /
Analysis /
Instructional
Program
S-5-E
Exporter
specified drug preparations, containing a controlled chemical for retail, except drug preparations containing
Norephedrine / Phenylpropanolamine at doses 25 mg or below.
S-1
S-5-D
Bulk depot/storage
a. dangerous drug preparations in any form
S-3
D. in vitro diagnostic reagents, buffers and analytical standards, test kits containing dangerous drugs.
S-5-I
License to conduct laboratory analysis or technical research or
instructional / training programs using controlled substances or drugs containing controlled chemicals or plant sources of controlled substances.
S-6 or P-6
