Ra 9711-FDA Act of 2009
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Transcript of Ra 9711-FDA Act of 2009
7/25/2019 Ra 9711-FDA Act of 2009
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RA 9711: FDA Ac2009
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•AN ACT STRENGTHENING AND RATIOTHE REGULATORY CAPACITY OF THEOF FOOD AND DRUGS (BFAD) BY ESTA
ADEQUATE TESTING LABORATORIES AOFFICES, UPGRADING ITS EQAUGMENTING ITS HUMAN RCOMPLEMENT, GIVING AUTHORITY T
ITS INCOME, RENAMING IT THE FODRUG ADMINISTRATION (FDA), ACERTAIN SECTIONS OF REPUBLIC ACTAS AMENDED, AND APPROPRIATIN
THEREOF
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SECTION 1:
RENAMING OF BFAD
•Bureau of Food and Dr
•Food and Drug Admini
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SECTION 3:
POLICY OF THE STATE
•Protect and promote the right to healtFilipino people
•Help establish and maintain an effectiv
products regulatory system and uappropriate health manpower developmresearch responsive to the country’s healand problems.
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SECTION 4:
OBJECTIVES OF THE ACT
• To enhance and strengthen the administr
technical capacity of the FDA in the regu
establishments and products under its jurisdicti
•To ensure the FDA’s monitoring and regulatoryover establishments and products under its juris
• To provide coherence in the FDA’s regulatory s
establishments and promote under its jurisdicti
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SECTION 5:
FUNCTIONS, POWERS AND D
OF FDA• To administer the effective implementation of th
regulations
• To assume primary jurisdiction in the collection of
health products• To analyze and inspect health products
• To establish analytical data to serve as basis for the of health products standards and to recommend s
identity, purity, safety, efficacy, quality and fill of cont
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• To issue certificates of compliance with technical requ
serve as basis for the issuance of appropriate autho
spot check for compliance with regulations
• To conduct appropriate tests on all applicable healprior to the issuance of appropriate authorization
safety, efficacy, purity and quality
• To require all manufacturers, traders, distributors
exporters, wholesalers, retailers, consumers, and nousers of health products to report to the FDA any in
reasonably indicates that said product has caused or
to the death, serious illness or serious injury to a
patient or any person.
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• To issue cease and desist orders motu proprio or up
complaints for health products, whether or not reg
the FDA
• After due process, to order the ban, recall and/or wiany health product and to require all concerned to
risk management plan which is a requirement for the
the appropriate authorization
• To strengthen the post marketing surveillance monitoring health products
• To develop and issue products and appropriate aut
that would cover establishments, facilities and health
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• To conduct, supervise, monitor and audistudies on health and safety issues of healtundertaken by entities duly approved by the F
• To maintain bonded warehouses and/or estsame, whenever necessary or appropdetermined by the director-general for c
goods in strategic areas of the country esmajor ports of entry.
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COSMETICSREGULATION
ANDRESEARCH
FOODREGULATION
ANDRESEARCH
DRUGREGULATION
ANDRESEARCH
SECTION 6:
NEW CENTERS OF FDA
Each Center shall be headed by a director who shall b
by an assistant director
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Director
Licensing andRegistrationDivision
Product
Research andStandardsDevelopment
Division
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ADMINISTRATION ANDFINANCE OFFICE
HUMADEV
PROPERT
MAN
HUMAMAN
FINANCIA
INFORCOMM
TECHNOLO
DEPUTY DIRECTOR
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DIRECTOR GENERAL
Deputy Director General for
administration and finance
Deputy Director for field regulatoryoperations
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OFFICE OF THEDIRECTOR-GENERAL
Policy and Planning Office
Legal Services Support Ce
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QUALIFICATIONS
• DIRECTOR GENERAL
- Degree in Medicine or at least the relevant master’spharmaceutical sciences or allied sciences, or equivalent cregulatory management
• DEPUTY DIRECTOR-GENERAL FOR FIELD REGULATORY OP
- Master’s Degree in pharmaceutical sciences or allied sciences executive course in any regulatory management.
• DEPUTY DIRECTOR-GENERAL FOR ADMINISTRATION AND
- Certified public accountant or shall possess a master’s degree inmanagement, economics or any business course
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RA 3720 RA 9711
Imprisonment of not less thanone (1) year but not more than
five (5) years
Imprisonment rang(1) year but not mo
(10) year
Fine of not less than 5,000 pesosbut not more than 10,000 pesos,
or both such imprisonment and
fine, in the discretion of theCourt
Fine of not less tthousand pesos (P50
not more than Fiv
thousand pesos (P
SECTION 12:
PENALTIES
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• If the offender is a manufacturer, importer or
of any health product:
PENALTY – at least five (5) years imprisonmemore than ten (10) years and a fine of at least fiv
thousand pesos (P500,000.00) but not more
million pesos (P5,000,000.00) shall be imposed.
ADDITIONAL fine of 1% of the economic value/violative product or violation, or one thous
(P1,000.00), whichever is higher, shall be impose
day for continuing violation
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• Should the offense be committed by a juridic
the Chairman of the Board of Directors, the
general manager, or the partners and/or persoresponsible therefore shall be penalized.
• Should the offense be committed by a foreig
he/she shall in additional to the penalties pres
deported without further proceedings after sentence.
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SECTION 13:
ADMINISTRATIVE SANCTIO
• Cancellation of any authorization which may have been gFDA, or suspension of the validity for such period of time ageneral may deem reasonable which shall not exceed one
• Fine not less than fifty thousand pesos (P50,000.00) but five hundred thousand pesos (P500,000.00). An additio
more than one thousand pesos (P1,000.00) shall be impday of continuing violation
• Destruction and/or appropriate disposition of the sproduct, and/or closure of the establishment for any violatas determined by the director-general
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SECTION 14:
ADDITIONAL POWERS AND FUNCT
THE DIRECTOR-GENERAL
• To hold in direct or indirect contempt any person w
orders or writs he or she issues and impose the appro
following the same procedures and penalties provid
of Court
• To administer oaths and affirmations and issue s
tecum and subpoena ad testificandum
• To obtain information from any officer or office of
local governments, government agencies and its instr
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• To issue orders of seizure, to seize and hold i
any article or articles of food, device, c
household hazardous substances and health
that is adulterated, counterfeited, misbra
unregistered, or drug, in-vitro diagnostic
biological, and vaccine that is adulterated or mwhen introduced into domestic commerce
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• To call on the assistance of any departmeor agency and deputize members of the PNational Police or any law enforcement athe effective implementation of this Act
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SECTION 17:
FEES AND OTHER INCO
•Upon the sole approval of the Secreauthorization and other fees shall andetermined and reviewed by the FDAproposed increase shall be published ileading newspapers of general circulation
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• All income that the FDA is allowed tshall be deposited in an aut
government depository bank as a
regulatory fund .
SECTION
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SECTION 19:
ESTABLISHMENT OF REU
•The FDA shallestablish a RegulatoryEnforcement Unit
(REU) for a period notexceeding five (5)years from theeffectivity of this Act.
REU
Deputy
DirectorGenera
5 qualifiepersonnel
every regi
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R
E UBear arms,
wear officialuniforms andinsignias andshall beclassified as
lawenforcementagents
R
E UServe and
executerulings, orders,and decisionsof theDirector-
General of theFDA
R
E UExe
servwaarreissucou
conwit
SECTION 20:
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SECTION 20:
TESTING LABORATORY AND F
OFFICES
• FDA is hereby mandated to improve, up
increase the capability of the agency, to test
assay and examine samples of health products.
• there shall be established at least one laboratory each in Luzon, Visayas and Minda
shall have the necessary and appropriate state
laboratory equipment and personnel compleme
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•The main testing laboratories at the censhall be maintained and shall serve as
unit to the centers for product reseaevaluation and standards development.
• The existing laboratories in Cebu and D
be upgraded and transformed as quality laboratories, while another one will be ein Subic, Zambales.
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•The FDA shall establish field offiregions of the country to ef
implement its regulatory function
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SECTION 28:
EFFECTIVITY
•This Act shall take effect fifteen (1
after its publication in the Official Gain two (2) newspapers of general circu
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June 3, 2009
Quiz on RA 9711
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Quiz on RA 9711
1. The collective term used to refer to any incident that reasonabthat a particular product has caused or contributed to the deatillness or serious injury to a consumer, patient or any person.
2. The term _______is used to refer to a decision by FDA to initiainvestigation into a situation on their own initiative.
3. The increased fine applicable for retailers who violate RA 3720
4. The increased fine applicable for manufacturers, importers, or
who violate RA 37205. The unit established in every region of the country to strength
regulatory capacity of FDA
Quiz on RA 9711
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Quiz on RA 97116. Should the offense be committed by a juridical person, _______
penalized.
7. Which previous division of FDA had been replaced by drug, devicosmetics and food REGULATION AND RESEARCH
Indicate what divisions of FDA will perform the following functions:
8. To assume primary jurisdiction in the collection of samplproducts
9.To analyze and inspect health products
10. To establish analytical data to serve as basis for the preparatproducts standards and to recommend standards of identity, pefficacy, quality and fill of container