OUR LADY OF FATIMA UNIVERSITY
College of Pharmacy
PUBLIC HEALTH & REGULATORY
PHARMACY
(Supervised Pharmacy Practice Experience)
MODULE 2: Licensing of Drug
Outlets & Pharmaceutical
Establishments
ACTIVITY:
• ON-LINE LECTURE THROUGH
ZOOM
• DURATION: __ HOUR
• TOPIC: Module 2: Licensing of
Drug Outlets & Pharmaceutical
Establishments
OUTCOMES:
1. Classify pharmaceutical establishments
according to the given criteria.
2. Evaluate the submitted LTO documents of
the applicant establishment using the
requirements checklist.
3. Discuss the processing of documents for
licensing/renewal of LTO.
4. Discuss the protocol in the cancellation of
an LTO.
OUTLINE:
• AO 2016-003
Scope
Licensing of Establishments
Requirement
Initial Application
Renewal Application
Application Process
Variations
Cancellation of LTO
Validity of LTO
SCOPE
This order shall apply to the four FDA centers and the
FROO (Field Regulation and Operations Office).
• Center for • Center for • Center for • Center for
cosmetics Drug Food Device
Regulation Regulation Regulation Regulation,
and Research and Research and Research radiation
Health and
Research
CCRR CDRR CFRR CDRRHR
LICENSING OF ESTABLISHMENTS
Cover the following establishments, whether
public or private:
Manufacturer, traders & distributors (importers,
exporters & wholesalers) of processed food, drugs,
cosmetics, medical devices, reagents, household
products, toys and child care
Drug Outlets (Botica, Hospital Pharmacy &
Institutional Pharmacy)
Retail outlet for non-prescription drugs including
non-traditional outlets such as supermarkets and
store (RONPD)
INITIAL APPLICATION
Accomplished Application Form and
Declaration of Undertaking
Proof Business Name Registration
Site master file (manufacturer)
Risk management plan
Payment
Application form should contain the following:
• Declaration of undertaking of the
responsibilities of the applicant as the condition
for the processing and approval of LTO
• The location plan and GPS coordinates
• The name of the qualified person (pharmacist)
with credentials.
Qualified person with credentials
The names of the following should also be listed:
Proof Business Name Registration
Single Proprietorship
Certificate of business registration issued by DTI
Partnership/Corporation
Certificate of registration issued by SEC &
Articles of Incorporation
Proof Business Name Registration
Cooperative
Certificate of registration issued by the
Cooperative Development Authority & Articles
of Cooperation
Government-owned or controlled corporation
The law creating the establishment, if with
original charter or Certificate of registration
issued by SEC & Articles of incorporation if
without original charter.
Site Master File
• For manufacturers of drugs, devices and
cosmetics
• As required by the applicable GMP for the type
of establishment.
Risk Management Plan
• For manufacturers and distributors of drugs &
medical devices establishments, drugstores &
RONPDs
• Shall contain details how to identify and
minimize risks relating to the products of the
establishment
• Include post-marketing surveillance and
interventions to manage risks
Payment
• Official receipt or bank payment slip must be
attached to the application
RENEWAL APPLICATION
Accomplished application form and
Declaration & undertaking
Payment
APPLICATION PROCESS
Submission
of application
Evaluation Inspection
FDA portal
website
VARIATIONS
Major Variation
Minor Variation
*VARIATIONS SHALL REQUIRE FDA APPROVAL
Major Variation
Transfer of location of manufacturing plant
and drug retailers
Expansion of manufactures
Additional production line
Change of manufacturing activity
Transfer/ Addition of warehouse
Minor Variation
Transfer of location of offices
Change of distributor activity
Expansion of office establishments and drug
retailers
Additional drugstore activity
Change of ownership
Change of business name
Zonal change in address
Change of qualified personnel
Deletion of activity
CANCELLATION OF LTO
Automatic
Voluntary
Cancellation as penalty
When the license is cancelled either
automatically or voluntarily, the FDA shall retain
jurisdiction over the violations committed by
establishment while it was in operation
All establishments shall settle all their
monetary obligations to FDA
VALIDITY OF LTO
Initial application
2 years
Renewal application
5 years
FDA Circular No. 2020-030
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
https://www.fda.gov.ph/wp-
content/uploads/2020/10/FDA-Circular-No.-
2020-030-1.pdf
ACTIVITIES FOR
NEXT MEETING
Licensing of Drug
Outlets & Pharmaceutical
Establishments
REFERENCES:
• https://www.fda.gov.ph/wp-
content/uploads/2021/03/Admi
nistrative-Order-No.-2016-
0003.pdf
• https://www.fda.gov.ph/wp-
content/uploads/2020/07/Draft-
Guidelines-for-the-Use-of-the-
FDA-eServices-Portal-for-LTO-
Application.pdf
• https://www.fda.gov.ph/
• https://www.fda.gov.ph/wp-
content/uploads/2020/10/FDA-
Circular-No.-2020-030-1.pdf
ANY QUESTIONS?
