Summary of Philippine

AO, EO, MC, and BC

PHARMACEUTICAL JURISPRUDENCE AND ETHICS 2020
AO 220 s. 1974

DRUGS: cGMP in Manufacture, Processing,

Packing or Holding
This order prescribes the conditions and
requirements for GMPs applied to premises,
equipment, personnel, product, and warehouse
AO 42 s. 1982

Drug registration of herbal and/or traditional drugs, both

local and imported
This defines rules and regulations governing the
registration and sale of herbal and/or traditional drugs to
ensure their quality and safety.
AO 55 s. 1988

Requirements for Labeling Materials of Pharmaceutical

Products
Pursuant to both RA3720 and RA6675, it is a requirement
that generic names shall be the one with the highest point
size, printed in full, and enclosed exclusively by an outlined
box.

If the product is identified by a brand name, the GN shall

be one point size bigger but in the same typeface, font,
and color as the BN and shall appear immediately above
the latter.
AO 64 s. 1989
Amendment of AO 55 s. 1988
Amendments:
a. Caution for prescription drugs: “FDDC Act prohibits
dispensing without prescription”
b. Labels for products containing 2 or more API: “Products
containing two or more AI shall have generic name as
determined by BFAD”
c. Labels for products in strip or blister pack: “strength,
expiry date, company name, batch numbers must
appear for every standard strip”
d. Effectivity of generic labelling– reset from April 01, 1989
to July 01, 1989 production
AO 56 s. 1989 (outdated); AO 34 (new)

Revised Regulations for the Licensing of Drug establishments and

outlets
This order prescribes what are the activities involving drug
products that need to be covered by a license from BFAD.

Identifying these activities, the regulations provide for the

requirements applicable to all categories or activities and the
specific requirements for each category.

The order further provides for the conditions for renewal and
sanctions for deficiencies or failure to comply with the
requirements.
AO 67 s. 1989

Revised Rules and Regulations of Registration

This order provides comprehensive guidelines on the
registration of pharmaceutical products and to be
consistent with RA 6675:
- Initial product registration
- Renewal
- Registration schedule
AO 103 s. 2002

Batch Certification of Antibiotics

This was established to “reinforce the principle that the
ultimate responsibility of ensuring the quality, safety and
efficacy of pharmaceutical products rests with the
manufacturers, traders, distributors, and/or product
owner”

ALL ANTIBIOTICS (WITH NO EXEMPTIONS) ARE SUBJECT TO

BATCH CERTIFICATION
AO 4 s. 1992

Policy and Requirements for Availing of CSP for restricted

Use of Unregistered Drug and Device Product/ Preparation
CSP: Compassionate Special Permit

This order allows patients (especially those who are

terminally or seriously ill –AIDS, Cancer, etc.) to sue
preparation that are yet to be registered in the Philippines
since the need for use of such products is justifiable
ethically and morally.
AO 27 s. 2001 & AO 47 s. 2001

AO 27:Rules and Regulations for Licensing Local

Manufacturers of vaccines and biologic products
AO 47: Rules and regulations on the Registration, Including
approval and conduct of Clinical Trials, and Lot or Batch
realease Certification of vaccines and biologic products.
This is to ensure that vaccines are consistently produced
and controlled to the quality standards appropriate to
their intended uses
EO 119

Reorganizing the Bureau of Food and Drugs

BFAD Organizational units:
▪ Office of the Director
▪ Regulation Division I (outlets)
▪ Regulation Division II (Manufacturer)
▪ Laboratory Services Division
▪ Product Services Division
▪ Legal, Information, and Compliance Division
▪ Administrative Division
MC 17 s. 1989

Monitoring of Drugstore Pharmacist’s Office Hours

All drugstores are warned to open their outlets to the
public with the presence of BFAD-registered managing
pharmacist– such as that a drug outlet should be closed if
the pharmacist is out.
 MC 15 s. 1990
Exemption from the requirement providing one pharmacist for each licensed activity
“ if a drug establishment engages in activities belonging to more than one of the
categories, applicant must apply for LTO for each of the categories and pay the
corresponding fees”

Exemption from this may be under the following conditions:

a. Activities to be licensed belong to one establishment only
b. Activities handled by a pharmacist are confined only to the office and warehouse
c. Activities that are possibly accomplished under one roof or the same premises
d. Maximum number of drug and non-drug products do not exceed 30 (for traders),
50 for Distributors, importer, exporter); and provided that the volume of
transactions can be adequately handled by one pharmacist
e. Regional or provincial branch employing one pharmacist– as long as it is limited to
distribution and or wholesaling.
MC 05 s. 1991

The Designation and Registration of an Official Liaison

Officer
This circular encourages the designation of an official
liaison officer (see BC 02 for the definition), preferably, a
pharmacist within a certain drug establishment.
MC 09 s. 1990
Revised Implementating guidelines for the Effective Implementation of AO 151
s. 1971
Re: Certification of Antibiotics
Batch certification requirements:
Accomplish BFAD BCA Form No. 1, containing:
- Business name, address, lot no./vicinity
- Products to be certified (GN, BN, DF, strength, DR no and Validity of
registration, Batch/Lot no & batch size, Manufacture and Expiry dates,
Packaging)
- Certificate of Analysis (results of assays, tests, company monograph used for
testing)
Submit complete terminal QC record of the batch

BFAD will issue certification if after analysis, the batch is produced by an

establishment who conforms with specifications and standards
MC 1 s. 1991 & MC 4-A s. 1991

MC1: Registration of Medical Devices and Diagnostic

Reagents
MC4-A: Amending List I-A and List II of MC no. 1 s. 1991
This circular provides a definite list of devices and reagents
that need to be registered.
MC 19-A s. 1992

Specific Standards & Requirements for Registration of Cosmetic

Products
In line with AO 150 which provides that a cosmetic specialty shall
be distributed only after having been officially registered with the
BFAD, this order provides guidelines for the registration of
cosmetics including labeling requirements for cosmetic products,
specific products (those packaged in self-pressurized containers,
hair dyes, feminine deodorant sprays, bubble bath products,
shampoos and conditioners, borax-containing cosmetics,
eyebrow pencils, eyeliners, hair straighteners, depilatories,
perming lotions, nail polish, cosmetics for dandruff control, anti-
perspirant, beauty masks, or nail hardeners).
MC 5 s. 1994

Reports on Adverse Drug Reactions

Establishments are to submit reports of:
a. All suspected reactions to new drugs, especially drugs of
current interest
b. All suspected drug interactions
c. Reactions that could cause death, danger to life, admission to
hospital, prolonged hospitalization, absence from productive
activity, or birth defects.

Serious ADRs are to be submitted to BFAD within two weeks after

the receipt of the same. Other ADR reports shall be submitted on
or before January 15 of each year.
BC 02, s. 1997

Accreditation of Drug Liaison Officer to BFAD

Drug Liaison Officer- authorized personnel of an
establishment to have transactions with BFAD

Qualifications/ Requirements for the accreditation:

a. BS Pharm or BS Chem graduate
b. Officially designated by the licensed drug establishment
c. Payment of seminar fee
BC 21 s. 1999

Guidelines for the Evaluation of Brand Names for products

to be registered with the BFAD
This is for the purpose of clarifying and updating the
requirements and procedures in the evaluation of BN for
foods, drugs, medical devices, diagnostic reagents,
cosmetics, and household hazardous products to be
registered with the BFAD.
BC 22 s. 1999

Deletion of the requirement for a Certificate of Brand

Name Clearance in Filing an Application for Registration
of Branded Products
“BFAD shall now accept applications for registration of
branded products without the need for pre-clearance of
brand names”
BC 4 s. 1999

New Protocol for Registration of Drugs, Foods, Cosmetics &

Medical Devices
Samples for physico-chemical analysis are not required,
but, samples may be submitted for physical evaluation or
verification of specifications

Complete documentation to support claims of safety,

efficacy, identity, and quality must be submitted, and the
approval or disapproval will be based on completeness of
submitted documents
BC 6, s. 1999

Revised no. 4 s. 1999 New Protocol

*from BC 4:

**…approval or disapproval by Product Services Division

**No follow-up by regulatory officers or company

representative will be entertained before the 90 day
period following acceptance of the application as
provided by PAICS
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