AO 56 revised presentation

AMENDMENT OF
ADMINISTRATIVE ORDER 56 s. 1989
JOSELYN R. GUZMAN, RPh,MPA
FDRO II

SUBJECT: Rules and Regulations on the Licensing
of Drug Establishments and Other Related
Authorizations Further Amending for this Purpose
Administrative Order No. 56 s. 1989 on the
“Revised Regulations for the Licensing of Drug
Establishments and Outlets,” and for other
Purposes

A.O. 56 s. 1989
Pursuant to Section 26(a) in relation
to Section 21(a) and 11(k) of
Republic Act No. 3720, known as the
Foods, Drugs and Devices, and
Cosmetics Act as amended by
Executive Order No. 175 s. 1987 and
consistent with Republic Act No.
6675, known as the Generic Act of
1988, the following regulations are
hereby promulgated governing drug
establishments and drug outlets
under the Bureau of Food and Drugs
(BFAD).
Revised Guidelines
I. RATIONALE
II. AUTHORITY/BASES
III. OBJECTIVES
IV. SCOPE
…

I. RATIONALE
Section 15, Article II of the 1987 Constitution
declared it the policy of the State to protect and promote
the right to health of the people and instill health
consciousness among them. The Constitution also
mandates the State to adopt an integrated and
comprehensive approach to health development which
shall endeavor to make essential goods, health and other
social services available to all the people at affordable cost
(Section 11, Article XIII).

I. RATIONALE
Republic Act No. 3720 as amended by RA 9711 and
its implementing rules and regulations, and RA 7394, in
implementing the above Constitutional policy, declares
further as a policy of the State to insure safe and good
quality of food, drugs, and cosmetics, and to regulate the
production, sale, and traffic of the same to protect the
health of the people. In so doing, the same laws, empower
the Food and Drug Administration to issue licenses to
establishments manufacturing and/or distributing
pharmaceutical products.

I. RATIONALE
Republic Act No. 8792 or the “Electronic Commerce Act of
2000” declares it as an objective to facilitate domestic and
international dealings, transactions, arrangements, agreements,
contracts and exchanges, and storage of information through the
utilization of electronic, optical and similar medium, mode,
instrumentality and technology to recognize the authenticity and
reliability of electronic documents related to such activities and to
promote the universal use of electronic transaction in the
government and general public. The above objective of RA 8792
and its Implementing Rules and Regulations mandate the use of
electronic data messages, electronic document and electronic
signatures in government transactions.

I. RATIONALE
Republic Act No. 9502, otherwise known as the
“Universally Accessible Cheaper and Quality Medicines Act
of 2008” and its Implementing Rules and Regulations
provides as a policy of the State that when the public
interest or circumstances of extreme urgency so require, it
shall adopt appropriate measures to promote and ensure
access to affordable quality pharmaceutical products for all
through an effective competition policy in the supply and
demand thereof.

I. RATIONALE
Therefore, pursuant to the foregoing, to streamline
regulatory approaches in licensing of drug establishments;
provide faster access of pharmaceutical products to the
public; and promote transparency through the universal
use of electronic transaction in the government and general
public, the following rules and regulations in the licensing
of drug establishments as provided below are hereby
adopted and prescribed for the information and
compliance of all concerned.

II. AUTHORITY/BASES
This Order is issued by virtue under:
•Section 26 of Republic Act No. 3720 as amended by Republic Act 9711
otherwise known as “FDA Act of 2009”;
•Republic Act No. 7394 or the “Consumer Act of the Philippines”;
•Republic Act No. 9502, otherwise known as the “Universally Accessible
Cheaper and Quality Medicines Act of 2008”;
•Republic Act No. 6675 or the “Generics Law of 1988” as amended;
•Republic Act No. 5921 or “The Pharmacy Law” as amended;
•Executive Order No. 292 or the Administrative Code of 1987;
•and Section 27, Part IV of Republic Act No. 8792 or the “Electronic
Commerce Act of 2000.”

III. OBJECTIVES
1. Further amend the existing rules and regulations in the
licensing of drug establishments to align with the
recently promulgated laws and adopted policies
affecting drug establishments;
2. Ensure the public that establishments licensed by FDA
comply with current regulatory standards such as, but
not limited to, Good Manufacturing Practice (GMP),
Good Distribution Practice (GDP), Good Storage Practice
(GSP), Good Pharmacy Practice (GPP) and Good
Dispensing Practice.

III. OBJECTIVES
3. Prescribe the use and implementation of new
innovations, such as but not limited to, electronic data
messages, electronic submission of documents and
electronic signatures in the Food of Drug Administration
pursuant to Republic Act No. 8792 or the “Electronic
Commerce Act of 2000.”

IV. SCOPE
– This Order shall apply to all drug establishments, including local
government units, government owned and controlled
corporations, non-government organizations, other government
offices and instrumentalities engaged in the manufacture,
importation, exportation, sale, offer for sale, distribution in
wholesale and/or retail basis and transfer of pharmaceutical
product.
– Entities engaged in the activities such as donation, promotion,
advertising, or sponsorship of pharmaceutical product shall be
responsible therefor and shall secure an authorization.

A.O. 56 s. 1989
In accordance with Section 3 Paragraph
5 & 6 of RA 6675, any organization,
company or business establishments in the
pharmaceutical industry shall fall under the
following general classifications;
I. Drug Establishment means any
organization or company involved in the
manufacture, importation,
repacking and/or distribution of drugs or
medicines. This is covered by Chapter I
below.
II. Drug Outlet means drugstore,
pharmacy, and other business
establishment which sells drugs or
medicines. This is covered by Chapter II
below.
Revised Guidelines
V. DEFINITION OF TERMS
VI. GENERAL PROVISION

As used in this Order, the following words, phrases or terms shall have
the following meaning:
1. FDA – shall refer to the Food and Drug Administration
2. Drug Establishment – a sole proprietorship, a partnership, a
corporation, an institution, an association, or an organization
engaged in the manufacture, importation, exportation, sale,
offer for sale, distribution in wholesale and/or retail basis,
donation, transfer, use, testing, promotion, advertising, or
sponsorship of pharmaceutical product including the facilities
and installations needed for its activities

3. PIC/S – means Pharmaceutical Inspection Co-operation
Scheme
4. Pharmaceutical products – are the same as drug or
medicinal products as defined in AO 2012-0008 “Adoption
and Implementation of PIC/S Guides for the Good
Manufacturing Practice for Medicinal Products

5. License to Operate (LTO) – is an authorization or permission
embodied in a document granted by FDA to any natural or
juridical person engaged in the manufacture, importation,
exportation, sale, offer for sale, distribution, and transfer of
pharmaceutical products
6. Professional Regulation Commission (PRC)- is a national
government agency created by Presidential Decree (P.D.) No.
223 dated June 22, 1973

7. Special Permit- is a form of authorization granted to
national government, local government unit, non-government
organization and other entities that procures
medicines for use of their constituents, medical missions and
other health programs, and other purposes such as donation,
promotion, advertising, or sponsorship of pharmaceutical
product

8. Pharmacy Compounding - is a practice in which a licensed
pharmacist combines, mixes, or alters ingredients in response
to a prescription to create a medication tailored to the
medical needs of an individual patient

9. Specialty pharmaceuticals - generally defined as products
used to treat chronic, high-cost, or rare diseases and can be
injectable, infusible, oral, or inhaled medications

VI. GENERAL PROVISIONS
A. No drug establishment shall manufacture, import, export, sell,
offer for sale, distribute, transfer, promote, advertise and/or
sponsor any activity that involves pharmaceutical product,
without a license or appropriate authorization from FDA
pursuant to this Order.
B. The recipient of donated pharmaceutical products, whether
foreign or locally manufactured, for purposes of either medical
missions or other health related programs, shall secure a special
permit prior to the product’s distribution. The products covered
herein shall not be available for sale in the market.

C. Any pharmaceutical product sold in its original packaging
(container), the seal of which has not been broken or tampered
with, the liability of ensuring its safety, efficacy, quality and/or
purity, rests upon all the stakeholders involved in the supply
chain shall be held liable thereof.
D. All drug distributors shall not sell directly to the general public
or consumer, unless they have license as a retailer.
E. The application must meet the required documentary and/or
technical requirements or appropriate standards.

F. Misrepresentations, false entries, or withholding of any relevant
data contrary to the provisions of the law, rules and regulations
or appropriate standards shall mean disapproval of the
application.
G. A violation with any of the terms and conditions of its license
shall likewise result in the disapproval of the application.
H. Applications may also be disapproved for similar causes as
determined by the FDA.

I. All licensed drug establishments must continuously comply with
the existing requirements, regulations and standards, otherwise
the establishment may be ordered close or their licenses
suspended or revoked motu proprio or upon petition by any
person.
J. Any pharmaceutical product imported or offered for import, the
sale or use of which has been banned or withdrawn for health
and safety reasons in the country of manufacture or country of
origin, shall likewise be banned and refused admission in the
Philippines.

K. Any pharmaceutical product that is declared by the Secretary of
Health or the FDA Director-General to be imminently injurious,
unsafe or dangerous shall be ordered for their immediate recall,
seizure or banning from public sale or distribution.
L. All entities, whether government or non-government offices,
that regularly procure medicines on wholesale basis from any
FDA authorized drug establishment for use of their constituents
must be licensed as a drugstore/pharmacy or distributor (see
Sec. 25 of RA 5921 and RA 3720)

M.Institutional Pharmacies procuring medicines on a wholesale
basis from any FDA authorized drug establishment for use of
their employees and dependents must likewise be licensed as
drugstore/ pharmacy.
N. Every pharmacy, drugstore, institutional or hospital pharmacy
whether owned by the government or a private person or firm
shall at all times when open for business be under the personal
and immediate supervision of a registered pharmacist except
otherwise allowed by pertinent laws.

O.All establishment applying for a license to manufacture, import,
distribute, sell vaccines and other biological products are
hereby directed to comply with the Cold Chain Management
requirement. Likewise, existing establishment handling the
same shall upgrade their cold chain management capabilities.
P. The FDA shall have the authority to verify all original or
authenticated copies of the submitted documents for LTO (See
Sec 27 & 28 of RA 3720).

Q. The FDA shall endeavor to integrate all electronic submissions
or processes into electronic format pursuant to Republic Act
No. 8792 or the “Electronic Commerce Act of 2000”
R. Rule 17. Non-Discriminatory Clause of IRR of RA 9502:
Section 1. General Rule
Section 2. Patented Drugs
Section 3. Permit to Import and Distribute
Section 4. Requirements for Request for Mandatory Carry
Section 5. Mandatory Carry
Section 6. Refusal to Sell Drugs and Medicines

A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
LTO
3. Renewal of LTO
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees

VII. Classification of
DRUG ESTABLISHMENTS

VII A. Drug Manufacturer
A.O. 56 s. 1989
any establishment engaged in operations
involved in the production of a drug,
including propagation, processing,
compounding, finishing, filling, packing,
repacking, altering, ornamenting and
labelling with the end in view of
storage, distribution or sale of the
product: provided that for the purpose
of this regulation the compounding
and filling of prescriptions in
drugstores and hospital pharmacies
shall not be considered as production
operations.
Revised Guidelines
any establishment engaged in any and all
operations involved in the production of
pharmaceutical products including
preparatory processing, compounding,
formulating, filling, packaging,
repackaging, altering, ornamenting,
finishing and labeling with the end in view
of its storage, sale or distribution;
provided, that the term shall not apply to
the compounding and filling of
prescriptions in drugstores and hospital
pharmacies.

a “DRUG MANUFACTURER” can be further classified into the following:
•DRUG MANUFACTURER-REPACKER
•DRUG MANUFACTURER-PACKER
•DRUG MANUFACTURER-TRADER
Drug Trader under A.O. 56 is now classified as a drug
manufacturer

refers to any establishment that repacks a finished drug product into smaller
quantities in a separate container and/or into secondary packaging,
including but not limited to
•Relabeling
•Stickering
•bundling for promo packs
with the end view of storage, distribution, or sale of the product. Provided, it shall
not cover repacking of drugs at the time of purchase for purposes of dispensing.

refers to any establishment that packages a bulk drug product into its immediate
container with the end view of storage, distribution, or sale of the product.

•DRUG MANUFACTURER-TRADER
refers to any establishment which is a registered owner of a pharmaceutical product
and the formulation and procures the raw materials and packing components, and
provides the production monographs, quality control standards and procedures, but
subcontracts the manufacture of such product to a licensed manufacturer.
In addition, a trader may also engage in the distribution and or marketing of its
products. A trader shall be categorized as a manufacturer.

VII B. Drug Distributor/Exporter
any drug establishment
that exports raw materials,
active ingredients and/or
finished products to another
country
any establishment that
exports raw materials, active
ingredients and finished
products for distribution to
other drug establishments
outside the country.

VII C. Drug Distributor/Importer
imports raw materials, active
ingredients and/or finished
products for its own use or
for wholesale distribution to
other drug establishments
or outlets
imports raw materials, active
ingredients and/or finished
products for wholesale
distribution to other local
FDA- licensed drug
establishment.

VII D. Drug Distributor-Wholesaler
any drug establishment
that exports raw materials,
finished products from local
establishments for local
distribution on wholesale
basis.
procures raw materials,
finished products from a
local FDA licensed drug
establishment for local
distribution on wholesale
basis.

VII E. Drugstore/Pharmacy/Botica and similar outlets
such as Hospital Pharmacy and Institutional Pharmacy
a drug outlet where
registered drugs, chemical
products, active principles,
proprietary medicines or
pharmaceutical specialties
and dental medicinal,
galenical or veterinary
preparations are compounded
and/or dispensed.
drug establishment where
registered drugs, chemical
products, specialty pharmaceutical
and dental, medicinal and
household remedies are dispensed
directly to the general public on a
retail basis.
Botika ng Barangay and its variants
that sell prescription product shall
be reclassified and required to
secure LTO as a drugstore.

VII F. Retail Outlet for Non-Prescription Drugs
(RONPD)
including non-traditional outlets such as
supermarkets and stores, means a drug
outlet where registered non-prescription
or Over-the-Counter (OTC) drugs are sold
in their original packages, bottles or
containers or in smaller quantities not in
their original containers
drug establishments such as
supermarkets, convenient stores and other
similar retail establishments licensed to sell
registered non-prescription or Over-the-
Counter (OTC) drugs which are sold in
their individual original and primary
packaging and are dispensed directly to
the general public on a retail basis.
Botika ng Barangay and its variants that
sell non-prescription or OTC product only
shall be reclassified and required to secure
LTO as a RONPD.

… I. Drug Establishments
1. Definition
License to Operate (LTO)
3. Renewal of LTO
5. Schedule of Fees
II. Drug Outlets
1. Definition
LTO
3. Renewal of LTO
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII.Requirements for Securing an LTO
IX. Renewal of LTO
XIV. Violations and Administrative
Sanctions

VIII. Requirements for Securing an LTO
Any qualified natural or juridical person
desiring to engage or operate in the
manufacture, packing, repacking, importation,
exportation, sale, offer for sale, distribution or
transfer of pharmaceutical products shall
comply with the requirements that FDA is
authorized to promulgate through the
appropriate issuance including amendments
thereto.

IX. Renewal of LTO
A.O. 56 s. 1989
The License to Operate shall have
the following validities for all
categories of drug establishments:
•Initial Application- 1 year
•Renewal Application- 2 years
At least one month prior to the
expiration of the LTO, drug
establishments shall apply to renew
their license.
In considering the renewal application,
BFAD shall ascertain the continued
compliance by the establishment with
the standards and requirements (General
and Specific requirements)
Revised Guidelines
Stipulated in Section XIII
Application for regular renewal of
license may be filed within six months
from its expiration.
Applications for Automatic Renewal
Detailed in Sections VIII, X, XI, XII, XIII

IX. Renewal of LTO
A.O. 56 s. 1989
In case of renewal of LTO, the
drug outlet must have a history of
satisfactory performance, consistent
with BFAD standards and
requirements, without any cases of
serious violation of laws, rules and
regulations
Revised Guidelines
Detailed in Sections VIII, X, XI, XII, XIII

IX. Renewal of LTO (A)
Application for regular renewal of license may be filed within six
months from its expiration.
An application received after expiration of the LTO shall be subject to a
surcharge or penalty equivalent to twice the renewal licensing fee and
an additional ten percent (10%) per month or a fraction thereof of
continuing non-submission of such application up to a maximum of
one hundred twenty (120) days.
OLD AO56:
A surcharge of fifty percent (50%) of the above fees shall be issued on
application for renewal filed after the validity of the license has lapsed. (AO 56
Chapter 2, Section 6)

Any application for renewal of license filed beyond the 120 days after
the original expiration shall be considered expired and shall be subject
to a fee equivalent to the total surcharge or penalty plus the initial
license fee. Such application shall undergo the initial filing and
evaluation procedure.

For applications for renewal filed within one hundred twenty (120) days
from its original expiry, the LTO shall be considered valid and existing
until a decision or resolution by the FDA is rendered on the application
for renewal.

IX. Renewal of LTO (B)
The Automatic Renewal
Automatic renewal shall apply to the following conditions:
1. The application is filed before the expiration date;
2. The prescribed renewal fee is paid upon filing of the application;
3. A sworn statement indicating no change or variation whatsoever in
the establishment is attached to the application.

IX. Renewal of LTO (C)
In considering both renewal application, FDA shall ascertain the
continued compliance by the establishment with the existing standards
and requirements. In either case above, the instances provided in Section
4, Article I, Book II of the IRR of RA 9711(Paragraph E, Item VI above) shall
be grounds for non-renewal of application.
“Paragraph E, Item VI
E. The application must meet the required documentary and/or technical
requirements or appropriate standards.”

Standards and Requirements for
License to Operate ( AO56 )
Documentary requirements specified in Sections I.2 and
II.2 “Standards and Requirements” in AO 56 are
transfered in the proposed FDA Circular:
Guidelines on the Implementation of Rules and Regulations on
the Licensing of Drug Establishments and Other Related
Authorizations Further Amending for this Purpose
Administrative Order No. 56 s. 1989 on the “Revised
Regulations for the Licensing of Drug Establishments and
Outlets,” and for other Purposes

FDA shall issue a certification for those FDA licensed
establishments applying for amendment during the validity of
their Licenses to Operate.
This certification shall form an integral part of the LTO attachment
issued at the time of LTO renewal. Consequently, all amendments
shall be incorporated once the LTO is re-issued for renewal. Thus,
previous LTO and certifications related to amendments shall be
surrendered to this Office.

Amendment referred hereto shall include the following:
1. Inclusion or deletion of product (finished or raw material) and/or product line
2. Inclusion or deletion of sources (including toll manufacturer/repacker, trader)
3. Change in business name/address of the source and/or manufacturer
4. Change of key personnel for Quality Assurance, Quality Control, Production Manager,
Authorized Person and Pharmacist as reflected in the LTO
5. Inclusion or deletion of activity e.g. from Manufacturer to Toll Manufacturer/
Repacker/ Importer/Exporter or Trader to Trader/ Importer/ Exporter
(raw materials or finished bulk products)

Other amendments, as enumerated below, shall require re-issuance
of License to Operate after the conduct of inspection as these
particulars are reflected in the LTO itself:
•Change of business name, ownership and transfer of location of
the establishment
•Re-classification of the establishment (e.g. from
Distributor/Importer to Distributor/Wholesaler), except for those
which were reclassified into another class of establishment (e.g.
from Distributor/Importer/ Wholesaler to Trader).

NOTE:
Change of Address for drug manufacturer is considered
opening, hence all the documentary requirements for
initial application shall be submitted and payment of the
initial license fee shall be made.

A. Filing of Applications
B. Where to File
C. Period to File

An application, whether initial, renewal, automatic
renewal or amendment, is deemed filed upon
submission of duly accomplished application form and
Self-Assessment Checklist (SAC) with the complete
attached required documents, payment of required fees
and acceptance of the authorized FDA officer.
Any application not pursued by the applicant within three (3)
months from filing shall be deemed discarded and will be
automatically cancelled and delisted from the application list.

B. Where to File
An application shall be filed with the respective Regional
Field Offices having jurisdiction over the establishment
or as defined in accordance with issuance.

B. Where to File
C. Period to File
Initial application. It shall be filed prior to operation subject to
compliance of the requirements and conduct of site inspection but in
no case shall the establishment commence to operate until the
issuance of the corresponding License to Operate.
Renewal application. Regular renewal shall be filed six (6) months prior
to expiration of the original validity of the LTO.
Automatic renewal shall be filed prior to the expiration of the original
validity of the LTO.

A. Place of Business, Warehouse or Plant
B. Display of Signboard and License
C. Request for Information

All the office, warehouse and plant shall be covered by a single license
notwithstanding their distance or different locations within one
locality indicating merely their address in the license, except when
any of the office, warehouse and plant carries an entirely different
and complete stage of operation for different product, in which case,
each shall be covered by separate license. In this instance, the
principal office address shall be reflected at the front page of the LTO
while the others at the back page thereof or secondary page
appended thereto.
The place of business should be situated in accordance with the zonal
site.

Every licensed establishment shall cause the public display the duly
issued license in a conspicuous place within the premises of the
establishment.

C. Request for Information
Any request for information whether by the company or any
other party shall be governed by the existing policies on
disclosure.

A. Validity
All Licenses to Operate shall have the following validity for any
classification of drug establishments from the date of
issuance reflected as such and renewal thereafter.
a. Initial – Initial LTO issued shall be valid for one year
b. Renewal- Renewed LTO shall be valid for two years
In either case, the LTO shall be valid only in the address indicated
therein and the warehouse or plant covered.

B. Lost or Destroyed LTO
An LTO shall be re-issued upon the filing of request with affidavit
of loss or affidavit of such destruction and other documents
whenever necessary and payment of the prescribed fee.
Provided that there is no change whatsoever in the
establishment, otherwise the same shall be treated as
amendment or initial as the case may be.

C. Cancellation of LTO
a. Automatic
Any application for renewal of a LTO filed after one-hundred
twenty (120) days after the expiration of the original validity
shall be automatically considered expired and cancelled.
Likewise, unrenewed LTO for successive years shall be
automatically cancelled and deleted from the list of
registered establishments.

b. Voluntary
The owner or authorized person of a licensed establishment
may apply before the FDA or its regional field office having
jurisdiction over the establishment for voluntary cancellation
of its existing license by filing a formal notification together
with the original LTO issued, or in case of loss or destruction,
an appropriate affidavit therefore.
Any voluntary cancellation intended to defraud the government, its creditors, and/or its
workers shall not deprive FDA jurisdiction to perform acts in ensuring the safety of the
public.

c. Involuntary
This shall be effected only on the grounds and procedures
provided in the Rules of Administrative Procedure provided
in the IRR OF RA 9711 or other relevant rules and regulations
in case of violation or upon petition by any party.
Nothing in this section shall restrict the FDA or the DOH in
imposing the penalty of suspension, revocation, or
cancellation of LTO or other authorization for administrative
violations of any other relevant laws or their implementing
rules and regulations.

Any notice of disapproval of applications for license or
authorization or suspension, revocation, or cancellation of an
existing license, or authorization must clearly state the
ground/s on which the disapproval, suspension, revocation,
or cancellation is based.

XIV. Violations and Administrative Sanctions
CHAPTER I - DRUG ESTABLISHMENTS
4.1. Grounds for Revocation of LTO
4.2. Grounds for Suspension of LTO
CHAPTER II - DRUG OUTLETS
4.1. Temporary Closure
4.2. Suspension of License to Operate
4.3. Revocation of License to Operate
Violations and administrative
sanctions shall be covered by a
separate issuance.
A.Re-application after Disapproval
B.Resumption after Suspension
C.Re-application after Revocation

Violations and administrative sanctions shall be
covered by a separate issuance.
A.Re-application after Disapproval
B.Resumption after Suspension
C.Re-application after Revocation

A. Re-application after Disapproval
The disapproval of an application is without
prejudice to re-application. However,
disapproval of application shall mean outright
forfeiture of payment.

B. Resumption after Suspension
The lifting of the order of suspension and the
resumption of the operation of an
establishment that have been issued a
suspension of its LTO, shall take effect only
after due application and satisfactory
compliance of the deficiencies for which it was
suspended.

C. Re-application after Revocation
Unless permanently barred, any establishment
whose LTO have been revoked may apply for
initial application after three years from date of
revocation.

Chapter I
Chapter II
Upon application for license to
operate, the drug establishment shall
be charged with the corresponding
non-refundable fees for each type of
activity or classification that it will
engage into. The fees shall be based
on the existing Administrative Order
on schedule of fees including any
applicable amendment thereto.

XVI. Separability Clause
If any of the provisions of this administrative order is found by a court of
competent jurisdiction to be void or unenforceable, in whole or in part,
such provision shall be deemed deleted from this Order but the remaining
provisions thereof shall remain in full force and effect.
XVII. Repealing Clause
All provisions of existing administrative orders, circulars, regulations and other
issuances inconsistent with this Order are hereby repealed or amended
accordingly.
XVIII. Effectivity Clause
This Order shall take effect after fifteen (15) days following its publication in a
newspaper of national circulation and upon submission to the University of
the Philippines Law Center;This AO is subject for review after 2 years from

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