Preliminary Flashcards
The Universally Accessible
Cheaper and Quality Medicine Act of 2008
RA 9502
The Generics Act Of 1988
RA 6675
The Pharmacy Law
RA 10918
The Tobacco Regulation Act of
2003
RA 9211
The Consumer Act of the
Philippines
RA 7394
The Price Act
RA 7581/10623
The Food Safety Act of 2013
RA 10611
The ASIN Law
RA 8172
The Special Law on Counterfeit Drug
RA 8203
The Food Fortification Law
RA 8976
The Comprehensive Dangerous Drugs Act
RA 9165
The Expanded Senior Citizens Act of
2003
RA 9257
The Household Hazardous Act
PD No. 881
The Milk Code of the Philippines
EO No. 51
The Responsible Parenthood and
Reproductive Health Bill of 2012
RA 10354
The Code of Sanitation of the Philippines
PD 856
Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration
AO 2016-003
CCRR
Center for
cosmetics
Regulation
and Research
CDRR
Center for
Drug
Regulation
and Research
CFRR
Center for
Food
Regulation
and Research
CDRRHR
Center for Device Regulation, Radiation Health, and Research
Certificate of business registration issued by DTI
Single Proprietorship
Certificate of registration issued by SEC &
Articles of Incorporation
Partnership/Corporation
Certificate of registration issued by the
Cooperative Development Authority & Articles
of Cooperation
Cooperative
The law creating the establishment, if with original charter or Certificate of registration
issued by SEC & Articles of incorporation if
without original charter.
Government-owned or controlled corporation
Guidelines for the Use of the FDA eServices
Portal System for License to Operate (LTO)
Application of Drug Distributors, Drug Traders,
drugstores, Retail Outlets for Non-prescription
Drugs (RONPD), Clinical Research Organizations
and Sponsors
FDA Circular No. 2020-030
Type of Recall
product:
defects/conditions that
are potentially life threatening or could result to
severe health risk, health impairement or effects
such as permanent damage to health or death
Class 1 Recall
Type of Recall
product:
product defects/
conditions that could cause poisoning or
temporary/medically reversible adverse
health problem or mistreatment.
CLASS II Recall
Type of Recall
product:
product
defects/conditions that may not pose a
significant hazard to health, but withdrawal
may have been initiated for other reasons.
CLASS III Recall
BIHC
Bureau of International Health Cooperation
BLHSD
Bureau of Local Health Systems and Development
HFSRB
Health Facilities and Services Regulatory Bureau
HPDPB
Health Policy Development and Planning Bureau
HPCS
Health Promotion and Communication Service
