Republic of the Philippines

Department of Health
Food and Drug Administration

Guidelines on the Implementation of New

Rules and Regulations on the Licensing of
Retail Outlet for Non-Prescription Drugs
(RONPDs) 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
18 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.Multiple RONPD Supervision
IV.Responsiblities of Supervising
Pharmacist
V. List of non-Rx Drugs
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 Regulation Outline
VI. Responsibilities of
Implementing Offices
VII. Transitory Provisions
VIII.Repealing/Separability Clause
IX. Effectivity
X. Annex A: Requirements
XI. 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

RONPD 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

RONPD 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 Supervising Pharmacist
 Valid PRC ID
 Certificate of Attendance to Licensing
Seminar
 List of other RONPDs supervised w/
addresses, LTOs #s, supervising hours

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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) Picture of Drugstore with display of
signage
• Picture of store signage bearing the name of
the establishment

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

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A. Documentary Requirements
(8) Self-assessment Toolkit

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 B. Evaluation of Application
Initially reviewed by regional offices to
determine compliance with Admin and tech
reqts

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 C. Post-licensing Inspection
• Routinely done for compliance to GDP and
GSP
• maV may require
• Subject to regulatory action

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 C. Post-licensing Inspection
In addition to the submitted application, the following
documents will be verified during inspection:
• Franchise Agreement
• Records/E-file (distribution cards, citizen and PWD
books)
• Reference materials (e.g., relevant Republic Acts, WHO
GDP and GSP Guide)
• SOPs
• IEC materials

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 C. Post-licensing Inspection
Preliminary report shall be issued to the
establishment after inspection

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

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

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 D. Application for Variation
3. Minor Variation-Notification
a. Change of Supervising Pharmacist

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 D. 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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 E. Accessibility
Forms – available at the FDA website

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 Republic of the Philippines
Department of Health
Food and Drug Administration

RONPD Regulation
MULTIPLE RONPD
SUPERVISION
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 MULTIPLE RONPD
SUPERVISION
1. The pharmacist is required to dedicate a
minimum of eight (8) hours a week of
physical presence in the RONPD
2. The RONPDs supervised is within
reasonable distance and can be travelled
within a maximum of thirty (30) minutes
3. A maximum of 5 RONPDs is allowed to be
supervised by a single pharmacist
DRAFT ONLY Center for Drug Regulation and Research
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 MULTIPLE RONPD
SUPERVISION
Appropriate disclosure must be made
during the application
RONPDs and/or pharmacists that shall
violate the abovementioned rules shall be
subject to appropriate legal actions

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 Republic of the Philippines
Department of Health
Food and Drug Administration

RONPD Regulation
RESPONSIBILITIES OF
SUPERVISING PHARMACIST
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 RESPONSIBILITIES OF
SUPERVISING PHARMACIST
responsible in assuring the safety, efficacy and
quality of pharmaceutical product
1. Inventory of products are properly
monitored and recorded including its
expiry date;
2. GSP and GDP are observed;

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 RESPONSIBILITIES OF
SUPERVISING PHARMACIST
responsible in assuring the safety, efficacy and
quality of pharmaceutical product
3. Any adverse drug reactions/events
reported by patients/consumers are
properly handled, documented, and
reported to FDA
4. updated with the latest issuances and
advisories from FDA

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 RESPONSIBILITIES OF
SUPERVISING PHARMACIST
responsible in assuring the safety, efficacy and
quality of pharmaceutical product
5. compliant with existing regulations

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 Republic of the Philippines
Department of Health
Food and Drug Administration

RONPD Regulation
LIST OF NON-
PRESCRIPTION DRUGS
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 LIST OF NON-
PRESCRIPTION DRUGS
Only selected non-prescription drugs may
be made available for sale in a RONPD
List in Annex C

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 Republic of the Philippines
Department of Health
Food and Drug Administration

RONPD 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

RONPD Regulation
TRANSITORY
PROVISIONS
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 Transitory Provision
Submitted upon renewal for existing
establishments
RMP
GPS Coordinates
Credentials of supervising pharmacists

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 Republic of the Philippines
Department of Health
Food and Drug Administration

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

RONPD Regulation
EFFECTIVITY

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 Republic of the Philippines
Department of Health
Food and Drug Administration

RONPD 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. Picture of RONPD with Display of Signage
7. Proof of Payment
8. 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

RONPD 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. Picture of the drugstore with signage
5. Proof of payment
6. 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 Supervising
Pharmacist
C There is a change of the supervising pharmacist

D 1. Letter of Request for Change

2. Application Form
3. Credentials of the new supervising pharmacist
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

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