REPUBLIC ACT 9711

An act strengthening and rationalizing the regulatory

capacity of the Bureau of Food and Drugs.

Prepared by: Fatimae I. Mariano, RPh.

The Food and Drug Administration

Act of 2009
Approved: August 18, 2009
Amendment of RA 3720
Bureau of Food and Drugs
Food and Drug Administration
Headed by a Director General
Assisted by two Deputy Director General

Licensing and Regulation Division

Product Research and Standards
Development Division
Laboratory Support Division
Radiation Regulation Division

Important Provisions:
To conduct appropriate tests on all applicable health

products prior to issuance of appropriate authorizations

Strengthen post marketing surveillance
Ban, recall, and/or withdrawal of any health product
found to have caused the death, serious illness or serious
injury to a consumer or patient.
One testing laboratory each in Luzon, Visayas, and
Mindanao with state-of-the-art equipment
Field offices in each region

PENALTIES
Imprisonment of at least 1 year but not more than 10
years
Fine of 50,000 but not more than 500,000
Manufacturer/Importer/Distributor
Imprisonment of at least 5 years but not more than 10
years
Fine of 500,000 to 5,000,000
ADMINISTRATIVE SANCTIONS
Cancellation/Suspension of any authorization granted by
FDA.
Destruction/Disposition of subject health product,
and/or closure of establishment

Muchas Gracias!
References:
www.fda.gov.ph