Republic of the Philippines

Department of Health
Food and Drug Administration

Guidelines on the Implementation of New

Rules and Regulations on the Licensing of
Drug Distributor-Importer, Exporter, and
Wholesaler-Establishments following
Administrative Order No. 2014-00xx, dated xx

Center for Drug Regulation and Research

Media Room, 1st Floor, Main Building
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
17 September 2014

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 Presentation Outline
A. Objectives of Meeting
B. Draft Regulation
C. Discussion

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 Regulation Outline
I. Rationale
II. LTO Applications
III.Exemption in Providing
Another Pharmacist for
Additional Licensed Activity
IV.Responsiblities of
Implementing Offices
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 Regulation Outline
V. Transitory Provisions
VI. Repealing/Separability Clause
VII. Effectivity
VIII.Annex A: Requirements
IX. Annex B: Variations

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 Republic of the Philippines
Department of Health
Food and Drug Administration

A. OBJECTIVES OF THE
MEETING
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Objectives of the Meeting
Discuss the draft regulation
Gather inputs/suggestions from
stakeholders
Test run the proposed forms for
application

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 Republic of the Philippines
Department of Health
Food and Drug Administration

B. DRAFT REGULATION

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
RATIONALE

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 Rationale
requirements for the applications for
initial and renewal issuance of License to
Operate (LTO), variations, as well as
other guidelines relevant to these
establishments

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
LTO APPLICATION

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A. Documentary Requirements
(1) Application Form
Completely filled-up
signed by the authorized personnel
duly notarized

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A. Documentary Requirements
(2) Proof of Business Name Registration
For single proprietorship - Certificate of
Business Registration issued by DTI
For corporation, partnership and other
juridical person - Certificate of Registration
issued by SEC and Articles of Incorporation

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A. Documentary Requirements
(2) Proof of Business Name Registration
For cooperative - Certificate of Registration
issued by the Cooperative Development
Authority and the approved by-laws
For government-owned or controlled
corporation - the law highlighting the
provision creating such establishment

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 A. Documentary Requirements
(2) Proof of Business Name Registration
Must specify exact and complete address,
where applicable:
• unit number • street
• Floor • Phase
• Building • Barangay
• Lot • city/ municipality
• Block • province

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A. Documentary Requirements
(3) Credentials of pharmacist and other
qualified personnel
For pharmacist
• Valid PRC ID
• Certificate of Attendance to Licensing
Seminar

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A. Documentary Requirements
(3) Credentials of pharmacist and other
qualified personnel
For other qualified personnel
• CV
• Training records to prove qualification

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A. Documentary Requirements
(4) Risk Management Plan
Details on:
• identify, characterize, prevent or minimize
risk
• PV activities and interventions to manage
risks

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A. Documentary Requirements
(5) Location Plan
• Sketch of the location
• “how to get there”
• Directions with landmarks
• GPS Coordinates

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A. Documentary Requirements
(6) Proof of Payment
• OR or payment slip

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A. Documentary Requirements
(7) Self-assessment Toolkit

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 B. Evaluation and Compliance to
GDP and GSP
(1) Desktop Evaluation
• Initially reviewed by regional offices to
determine compliance with Admin and tech
reqts

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 B. Evaluation and Compliance to
GDP and GSP
(2) Inspection
In addition to the submitted application, the
following documents will be verified during
inspection:
• QMS
• Quality manual and SOPs
• Distributorship agreements
• Reference materials
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 B. Evaluation and Compliance to
GDP and GSP
(2) Inspection
a)Pre-opening inspection
b) Post-licensing inspection
• Routinely done
• maV may require
• Subject to regulatory action

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 B. Evaluation and Compliance to
GDP and GSP
(2) Inspection
Preliminary report shall be issued to the
establishment after inspection
Carrying temperature sensitive products –
compliance with cold-chain mgmt

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 C. Application for Variation
1. Major Variation
a. Change of ownership
b. Transfer of location

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 C. Application for Variation
2. Minor Variation-Prior Approval
a. Change of business name
b. Change of activity
c. Zonal Change

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 C. Application for Variation
3. Minor Variation-Notification
a. Change of Pharmacist or other Qualified
Personnel
b. Deletion of Activity

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 C. Application for Variation
Other changes – notified to FDA
Other variations may be added
Transfer of location – initial fee
Other variations – existing fee

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 D. Accessibility
Forms – available at the FDA website

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
EXEMPTION IN PROVIDING
ANOTHER PHARMACIST FOR
ADDITIONAL LICENSED ACTIVITY
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 Exemption
Exemption for Drug Distributor pharmacist to
handle retailing activity provided the ff
conditions are met
1. Activities belong only to one
establishment (single business entity
with same name registration and
ownership)

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 Exemption
Exemption for Drug Distributor pharmacist to
handle retailing activity provided the ff
conditions are met
2. Activities are confined only in one
office/warehouse within the same
premises

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
RESPONSIBILITIES OF
IMPLEMENTING OFFICES
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FDA and Regional offices
May call on the assistance of any department
office and/or government agency for the
effective implementation of its rules and
regulations

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 LGUs
Enjoined in monitoring licensed
establishments
Report to FDA any violative establishments

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
TRANSITORY
PROVISIONS
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 Transitory Provision
Submitted upon renewal for existing
establishments
RMP
GPS Coordinates

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
REPEALING/
SEPARABILITY CLAUSE
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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
EFFECTIVITY

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
ANNEX A

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Initial LTO Application
1. Application Form
2. Proof of Business Name Registration
3. Credentials of Pharmacist and other Qualified
Personnel
4. Risk Management Plan
5. Location Plan
6. Proof of Payment
7. Self-Assessment Toolkit

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Renewal LTO Application
1. Application Form
2. Copy of Certifications issued as a result of
LTO Variation
3. Proof of Payment
4. Self-Assessment Toolkit

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 Reissuance of Lost or
Destroyed LTO
1. Letter of Request
2. Affidavit of Loss or Destruction
3. Proof of Payment

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Voluntary Cancellation
1. Letter of Request
2. Original LTO

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Distributor Regulation
ANNEX B

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 Change of Ownership
C change of ownership of the drug establishment
1. Letter of Request for Change
D 2. Application Form
3. Proof of business name registration reflecting the
new of owner
4. Deed of sale or transfer of rights of ownership
5. Proof of payment
6. Self-Assessment Toolkit

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 Transfer of Location
C 1. Physical transfer of the drug establishment
2. Other variations (change of personnel, business
name) may also be included as long as the variation
is noted in the letter of request and the unique
requirements from the additional changes are
included. The fees remain the same as initial fee,
regardless of the additional variation.

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 Transfer of Location
D 1. Letter of Request for Change
2. Application Form
3. Proof of business name registration reflecting the
new address
4. New Location Plan
5. Proof of payment
6. Self-Assessment Toolkit

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 Change of Business Name
C 1. Change only in the business name
2. No transfer of location or change of ownership.
1. Letter of Request for Change
D 2. Application Form
3. Proof of business name registration reflecting the
new name of the business/drug establishment
4. Proof of payment
5. Self-Assessment Toolkit

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 Change of Activity
C 1. additional activity engaged by the distributor (e.g.
LTO as Distributor-Importer with additional
activity as Exporter)
2. change from the initially licensed activity (e.g. LTO
as Distributor-Importer to Distributor-Exporter)
1. Letter of Request for Change
D 2. Application Form
3. Contract Agreements to prove activity
4. Proof of payment
5. Self-Assessment Toolkit
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 Zonal Change
C change of the name/number of the street/building
without physical transfer of the establishment.
1. Letter of Request for Change
D 2. Application Form
3. Document issued by the local municipality as proof of
zonal change
4. Proof of payment
5. Self-Assessment Toolkit

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 Change of Pharmacist or
Other Qualified Personnel
C 1. There is a change of the identified pharmacist
and/or other qualified personnel
2. For multiple pharmacists employed, the identified
responsible pharmacist that will be
replaced/changed shall be required to apply for
variation; the same goes for the other qualified
personnel

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 Change of Pharmacist or
Other Qualified Personnel
D 1. Letter of Request for Change
2. Application Form
3. Credentials of the pharmacist and/or other
qualified personnel
4. Proof of payment
5. Self-Assessment Toolkit

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 Deletion of Activity
C deletion of any approved/added distributor activity
1. Letter of Request for Change
D 2. Application Form
3. Termination of contract or conformance letter
4. Proof of payment
5. Self-Assessment Toolkit

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 Republic of the Philippines
Department of Health
Food and Drug Administration

C. DISCUSSION
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 Republic of the Philippines
Department of Health
Food and Drug Administration

Situation 1: (1 Variation)
DIW Trade, Inc. is a license holder of drug
distributor/wholesaler located at 415 Brgy., San
Antonio, Doña Soledad, Parañaque City. The said
company invested on additional imported
pharmaceutical products supplied by a foreign
distributor.

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Situation 2: (1 Variation)
ABC Company with an existing and valid LTO (CDRR-
NCR-DW-123) located at 56 Chino Roces Ave., Makati
City wishes to transfer their ownership rights to FDS
Pharma Distributor due to management decision.

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Situation 3: (2 Variations)
Biolab Research Inc. is a holder of an LTO as Drug
Importer located at 1234 –B Wagas St. Value Road,
Pasay City. Due to financial crisis, the management
decided to move into a less expensive space to
maximize the expenses. During this transition, their
pharmacist unexpectedly files resignation because of
personal reason.

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Situation 4: (1 Variation)
PRIME Corporation was issued an initial LTO as Drug
Distributor – Exporter on 30 April 2014 with an
opening fee of P5050.00. During the validity of its LTO,
an unavoidable circumstance mandated by
municipality to change its address from 25 Magiliw St.
Brgy. Mayapa, Zone 12, Calamba Laguna to 25 Magiliw
St. Brgy. Mayapa, Zone 10, Calamba, Laguna.

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 Republic of the Philippines
Department of Health
Food and Drug Administration

Situation 5: (2 Variations)
J&M Distributor, an existing Drug Distributor-
Wholesaler/Importer with valid LTO located at Taguig
City wants to terminate their contract with their
foreign suppliers to focus on wholesaling. Likewise,
the management decided to change its business name
to One World Distributors.

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 Republic of the Philippines
Department of Health
Food and Drug Administration

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