Download Revised Regulations for the Licensing of Drug - rho

Revised Regulations for the Licensing of Drug
establishments and outlets and for other purposes.
Revised AO 56
Rationale
 Section 15 Article II of the 1987 Constitution-protect and
promote the right to health of the people and instill health
consciousness among them.
 RA 3720 as amended by RA 9711and A 7394= to ensure safe
and good quality of food, drug, and cosmetics and to
regulate the production sale and traffic of the same to
protect the health of the people.
 RA 8972- Electronic commerce Act of 2000. To facilitate
domestic and international dealings. Transactions,
arrangements, agreements, contracts and exchanges and
storage of information through the utilization of electronic
medium or mode.
 RA 9502- Universally Accessible Cheaper and quality
Medicines Act of 2008- Provides the policy of the state
that when the interest or circumstances of extreme
urgency so require, it shall adopt appropriate measures
to provide and ensure access to affordable quality
pharmaceutical products for all through an effective
competition policy in the supply and demand.
 The streamlined regulatory approaches in licensing of
drug establishments,
 Provision of faster access of pharmaceutical products
to the public
 And promote transparency through the universal use
of electronic transaction in the government and the
general public.
Bases of authority
 Section 26 of RA 3720 as amended by RA 9711 ( FDA
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Act of 2009)
RA 7394- Consumers Act of the Philippines
RA 9502- Universally Accessible cheaper and Quality
Medicines Act of 2008.
RA 6675- Generics Act of 1988
RA 5921- The Pharmacy Law
Section 27 Part IV of RA 8792- Electronic commerce
Act of 2000.
Objectives
 1. Further amend the existing rules and regulations in
the licensing of drug establishments to align with
recently promulgated laws and adopted policies
affecting drug establishments.
 2. Ensure the public that establishments licensed by
FDA comply with current regulatory standards.(
GMP,GDP,GSP, GPP,GDP)
 3.Prescribe the use and implementation of new
innovations such as but not limited to Electronic data
messages, electronic submission of documents.
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 products.
 Entities engaged in the activities such as
 donation,
 promotion,
 advertising,
 or sponsorship of pharmaceutical products shall be
responsible therefor and shall secure an authorization.
General Provisions
 1.No drug establishments 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.
 2.The recipient of donated products whether foreign
or locally manufactured for purpose of either medical
missions or other health related programs shall secure
a special permit prior to product's distribution.
 3. 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 .
 4. All drug distributors shall not sell directly to the
general public or consumer, unless they have license as
a retailer.
 5. The application must meet the required
documentary and/ or technical requirements or
appropriate standards.
 6. Misrepresentation, 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.
 7. A violation of any of the term and conditions of its
license shall likewise result in the disapproval of the
application.
 8. Application may also be disapproved for similar
causes as determined by FDA.
 9. All licensed drug establishments must continuously
comply with the existing requirements, regulations
and standards, otherwise the establishment may be
ordered close or their license suspended or revoked
motu proprio or upon petition by any person.
 10. Any pharmaceutical product o 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.
 11. 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.
 12. All entities, whether government or non-
government offices, that regularly procure medicines
on wholesale basis from any FDA authorized drug
establishments for use of their constituents must be
licensed as drugstore /pharmacy or distributor. ( Sec.
25 of RA 5921 and RA 3720)
 13.Institutional Pharmacies procuring medicines on a
wholesale basis from any FDA authorized drug
establishments for use of their employees and
dependents must likewise be licensed as drugstore/
pharmacy.
 14. 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 supervision of a registered
pharmacist except otherwise allowed by pertinent law.
 15. All establishments applying for a license to
manufacture, import, distribute, sell vaccines and
other biological products are hereby directed to
comply with Cold Chain Management requirements.
Likewise existing establishments handling the same
shall upgrade their cold chain management
capabilities.
 16. FDA shall have the authority to verify all original or
authenticated copies of the submitted documents for
LTO. ( Sec. 27,26 of RA 3720)
 17. FDA shall endeavor to integrate all electronic
submission or processes into electronic format
pursuant RA 8792 or the Electronic Commerce Act of
2000.
 18 . Rule 17 non discriminatory clause of IRR of RA
9502.
 33. Non-Discriminatory Clause. - It shall be
unlawful for any retail drug outlet to refuse to carry
either by sale or by consignment, or offer for sale drugs
and medicines brought into the country, as allowed
under Section 7 of this Act which amends Section 72.1
of the Intellectual Property Code of the Philippines or
Republic Act No. 8293, by the government or
authorized third party which have been previously
approved for distribution or sale by the Bureau of Food
and Drugs. For this purpose, the said products shall be
displayed with equal prominence as all other products
sold in the establishment.
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Thank YOU
Article- XIV- Violations and
Administrative sanctions
 Violations and administrative sanctions shall be
covered by separate issuance.
 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 establishments 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.
Schedule of FEES
 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. The fees shall be based on the
existing Administrative Order on schedule of fees
including any applicable amendment thereto.