Guidelines on the Implementation of New Rules and ......Republic of the Philippines Department of...

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

1

Presentation Outline

A. Objectives of Meeting

B. Draft Regulation

C. Discussion

Center for Drug Regulation and Research 2

Regulation Outline

I. Rationale

II. LTO Applications

III.Exemption in Providing Another Pharmacist for Additional Licensed Activity

IV.Responsiblities of Implementing Offices


Regulation Outline

V. Transitory Provisions

VI. Repealing/Separability Clause

VII. Effectivity

VIII.Annex A: Requirements

IX. Annex B: Variations





A. OBJECTIVES OF THE MEETING

Objectives of the Meeting

Discuss the draft regulation

Gather inputs/suggestions from stakeholders

Test run the proposed forms for application





B. DRAFT REGULATION




RATIONALE

Distributor Regulation

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





LTO APPLICATION


A. Documentary Requirements

(1) Application Form

Completely filled-up

signed by the authorized personnel

duly notarized



(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




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




Must specify exact and complete address, where applicable:


• unit number • Floor • Building • Lot • Block

• street • Phase • Barangay • city/ municipality • province


(3) Credentials of pharmacist and other qualified personnel

For pharmacist

• Valid PRC ID

• Certificate of Attendance to Licensing Seminar



(3) Credentials of pharmacist and other qualified personnel

For other qualified personnel

• CV

• Training records to prove qualification



(4) Risk Management Plan

Details on:

• identify, characterize, prevent or minimize risk

• PV activities and interventions to manage risks



(5) Location Plan

• Sketch of the location

• “how to get there”

• Directions with landmarks

• GPS Coordinates



(6) Proof of Payment

• OR or payment slip



(7) Self-assessment Toolkit


B. Evaluation and Compliance to GDP and GSP

(1) Desktop Evaluation

• Initially reviewed by regional offices to determine compliance with Admin and tech reqts



(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



(2) Inspection

a)Pre-opening inspection

b) Post-licensing inspection

• Routinely done

• maV may require

• Subject to regulatory action



(2) Inspection

Preliminary report shall be issued to the establishment after inspection

Carrying temperature sensitive products – compliance with cold-chain mgmt


C. Application for Variation

1. Major Variation

a. Change of ownership

b. Transfer of location



2. Minor Variation-Prior Approval

a. Change of business name

b. Change of activity

c. Zonal Change



3. Minor Variation-Notification

a. Change of Pharmacist or other Qualified Personnel

b. Deletion of Activity



Other changes – notified to FDA

Other variations may be added

Transfer of location – initial fee

Other variations – existing fee


D. Accessibility Forms – available at the FDA website





EXEMPTION IN PROVIDING ANOTHER PHARMACIST FOR

ADDITIONAL LICENSED ACTIVITY


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)


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





RESPONSIBILITIES OF IMPLEMENTING OFFICES


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


LGUs Enjoined in monitoring licensed

establishments

Report to FDA any violative establishments





TRANSITORY PROVISIONS


Transitory Provision Submitted upon renewal for existing establishments

RMP

GPS Coordinates





REPEALING/ SEPARABILITY CLAUSE





EFFECTIVITY





ANNEX A


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


Renewal LTO Application

1. Application Form

2. Copy of Certifications issued as a result of LTO Variation

3. Proof of Payment



Reissuance of Lost or Destroyed LTO

1. Letter of Request

2. Affidavit of Loss or Destruction

3. Proof of Payment


Voluntary Cancellation 1. Letter of Request

2. Original LTO





ANNEX B


Change of Ownership


C change of ownership of the drug establishment

D

1. Letter of Request for Change

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


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.

Transfer of Location


D 1. Letter of Request for Change

2. Application Form


new address

4. New Location Plan

5. Proof of payment


Change of Business Name


C 1. Change only in the business name

2. No transfer of location or change of ownership.

D


2. Application Form


new name of the business/drug establishment

4. Proof of payment


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)

D


2. Application Form

3. Contract Agreements to prove activity

4. Proof of payment


Zonal Change


C change of the name/number of the street/building

without physical transfer of the establishment.

D


2. Application Form

3. Document issued by the local municipality as proof of

zonal change

4. Proof of payment


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

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


Deletion of Activity


C deletion of any approved/added distributor activity

D


2. Application Form

3. Termination of contract or conformance letter

4. Proof of payment





C. DISCUSSION




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.





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.




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.





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.




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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