- Other penalties registered health products;

- Fine: Without license to operate;

- Imprisonment: nlt 30 days Beyond its expiration
nmt 1 yr or both SEC 11 SEC 13
RA 3720 FOOD, DRUG, DEVICES AND COSMETICS ACT - Section 12 RA 3720 - Section 29-A RA 3720
CHAP 2 SEC 3 CHAP 3 SEC 4 - Any person - Cancellation authorization
- Declaration of policies - Powers, duties, - Imprisonment: 1 yr-10 yrs - Fine: 50k-500k, 100/day
- Standard quality FDDC responsibilities - Fine: 50k-500k
- Rational use FDDC - Administer and supervise - Offender
- Banning, recalling, - Samples of FDDC - Imprisonment: 5 yrs-10 yrs
withdrawing, adaptation - Inspect FDDC - Fine: 500k-5M
- Strengthen bureau of food - Analytical data RA 8203 SPECIAL LAW ON COUNTERFEIT DRUGS
and drugs - Certificate of compliance - SEPTEMBER 1996
- Fees for inspection - Appropriating fund
- Batches of antibiotic - Instill health consciousness Art 11 Sec 15
CHAP 3 SEC 5 CHAP 3 SEC 6 SEC 4 SEC 5

IA
- Inspection and licensing FDA administrator: Head, appointed by - Prohibited acts - Parties reliable
- Laboratory secretary of health - Brokering - Owner proprietor; Dispensary
- Amended RA 9711 - Possessions - Causes or allows
CHAP 3 SEC 7 CHAP 6 SEC 11 - Simulating or falsely; without - Sold or found; Third party;
- Secretary may add - Prohibited acts and penalties proper Constructive knowledge

GE
- Offering for sale - Oblitering or removing juridical person; Causes or
- Adulteration or misbranding - Concealing knowingly
of any food SEC 7 SEC 8
- Refusal - Closure and revocation - Section 4 possession of
- Undertaking false - Fine: 50k-500k, 1000/day counterfeit
- Forging; Any mark - Imprisonment: nlt 6 months, 1
- Trade secret

Y
day nmt 6 yr
- Alteration; Whole or any - Section 4 case mentioned
- Suggesting application - Imprisonment: nlt 6 yrs, 1 day
- FDA without authorization nmt 10 yrs
-
aH
Drug or device not registered - Fine: nlt 100k nmt 500k
- Person without license - Animals
- Beyond its expiration - Imprisonment: nlt 6 months, 1
- Without batch certification day nmt 2 yrs, 4 months
- Imprisonment: nlt 1 yr nmt 5 RA 6675 GENERICS ACT OF 1988
yrs - Production of adequate supply
k
- Fine: nlt 5k nmt 10k - Identified by generic names
CHAP 6 SEC 21 CHAP 9 SEC 22 SEC 2 SEC 4
- No person shall manufacture; - Certificate of drugs containing -require generic terminology generic terminology for essential
be

- Unless application filed antibiotics -generic names lowest possible -promotion of the generic names
- Cosmetics: Deleterious except -encourage extensive use -exclusive use of generic
hair dyes, skin irritation, -emphasize scientific basis
blindness, misbranded -by minimizing duplication
cosmetics with FDA.
SEC 5 SEC 6
CHAP 10 SEC 23 & 24 CHAP 10 SEC 26
-posting and publication will use generic terminology: government
- Adulterated and misbranded - Institution of criminal action
Re

-2 newspaper agencies (6a), medical, dental, veterinary,

cosmetics - Report products to FDA practitioners (6b), organization or
- FDA conduct testing company (6c)
- Complain parties, impeach
SEC 7 SEC 8
RA 9711 FOOD AND DRUG ADMINISTRATION ACT OF 2009 -manufacturer's identity and -promulgated by secretary of health
- AUGUST 18, 2009 responsibility -available to general public
- Strengthening and rationalizing -name and country; date manufacture
@

SEC 1 SEC 3 and expiration

- Renamed BFAD > FDA - Declared policy to adopt SEC 11 SEC 12
- Protect and promote; Help education drive: DepED, DOH, DILG, -penalty
and maintain philippine information agency -1st: reprimand (FIVA-false; unethical,
SEC 4 SEC 6 insanity, violation, addiction)
- Technical capacity, regulatory - Section 5 RA 3720 - 2nd: nit 2,000.00 nmt 5,000.00
coverage, coherence - New subsections added -3rd: conviction; nit 5,000.00 mt
SEC 7 SEC 10 10,000.00; suspension 30 days
- Section 6 RA 3720 -Section 11-A,B,D,G.J,K RA 3720 -4th: conviction and subsequent; nit
- DOH: Secretary 10,000.00 mmt; suspension 1 yr
- FDA: Director general - Sponsorship of health product -violates Section 6c, d,7,8. nit 5,000.00
- 2 deputy director general: - Adulterated; Misbranding of nmt 10,000.00; revocation er nit 6
Deputy for field regulatory health product; Guaranty or months nt 1 yr
operations, Deputy for undertaking RA 9502 UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF
administration and finance - Obliteration or removal; Not 2008

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