Rules and Regulations on the Licensing of Drug Distributor-Importer, - - PowerPoint PPT Presentation

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Rules and Regulations on the Licensing of Drug Distributor-Importer, - - PowerPoint PPT Presentation

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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

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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

Center for Drug Regulation and Research 2

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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

Center for Drug Regulation and Research 3

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Regulation Outline

V. Transitory Provisions

  • VI. Repealing/Separability Clause

VII.Effectivity VIII.Annex A: Requirements

  • IX. Annex B: Variations

Center for Drug Regulation and Research 4

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 5

  • 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

Center for Drug Regulation and Research 6

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 7

  • B. DRAFT REGULATION
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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 8

RATIONALE

Distributor Regulation

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Rationale

requirements for the applications for initial and renewal issuance of License to Operate (LTO), variations, as well as

  • ther guidelines relevant to these

establishments

Center for Drug Regulation and Research 9

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 10

LTO APPLICATION

Distributor Regulation

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  • A. Documentary Requirements

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

Center for Drug Regulation and Research 11

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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

Center for Drug Regulation and Research 12

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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

Center for Drug Regulation and Research 13

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  • A. Documentary Requirements

(2) Proof of Business Name Registration Must specify exact and complete address, where applicable:

Center for Drug Regulation and Research 14

  • unit number
  • Floor
  • Building
  • Lot
  • Block
  • street
  • Phase
  • Barangay
  • city/ municipality
  • 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

Center for Drug Regulation and Research 15

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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

Center for Drug Regulation and Research 16

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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

Center for Drug Regulation and Research 17

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  • A. Documentary Requirements

(5) Location Plan

  • Sketch of the location
  • “how to get there”
  • Directions with landmarks
  • GPS Coordinates

Center for Drug Regulation and Research 18

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  • A. Documentary Requirements

(6) Proof of Payment

  • OR or payment slip

Center for Drug Regulation and Research 19

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  • A. Documentary Requirements

(7) Self-assessment Toolkit

Center for Drug Regulation and Research 20

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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

Center for Drug Regulation and Research 21

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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

Center for Drug Regulation and Research 22

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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

Center for Drug Regulation and Research 23

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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

Center for Drug Regulation and Research 24

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

Center for Drug Regulation and Research 25

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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

Center for Drug Regulation and Research 26

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  • C. Application for Variation
  • 3. Minor Variation-Notification
  • a. Change of Pharmacist or other Qualified

Personnel

  • b. Deletion of Activity

Center for Drug Regulation and Research 27

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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

Center for Drug Regulation and Research 28

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  • D. Accessibility

Forms – available at the FDA website

Center for Drug Regulation and Research 29

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 30

EXEMPTION IN PROVIDING ANOTHER PHARMACIST FOR ADDITIONAL LICENSED ACTIVITY

Distributor Regulation

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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

  • wnership)

Center for Drug Regulation and Research 31

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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
  • ffice/warehouse within the same

premises

Center for Drug Regulation and Research 32

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 33

RESPONSIBILITIES OF IMPLEMENTING OFFICES

Distributor Regulation

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FDA and Regional offices

May call on the assistance of any department

  • ffice and/or government agency for the

effective implementation of its rules and regulations

Center for Drug Regulation and Research 34

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LGUs

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

Center for Drug Regulation and Research 35

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 36

TRANSITORY PROVISIONS

Distributor Regulation

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Transitory Provision

Submitted upon renewal for existing establishments RMP GPS Coordinates

Center for Drug Regulation and Research 37

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 38

REPEALING/ SEPARABILITY CLAUSE

Distributor Regulation

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 39

EFFECTIVITY

Distributor Regulation

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 40

ANNEX A

Distributor Regulation

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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

Center for Drug Regulation and Research 41

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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

Center for Drug Regulation and Research 42

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Reissuance of Lost or Destroyed LTO

  • 1. Letter of Request
  • 2. Affidavit of Loss or Destruction
  • 3. Proof of Payment

Center for Drug Regulation and Research 43

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Voluntary Cancellation

  • 1. Letter of Request
  • 2. Original LTO

Center for Drug Regulation and Research 44

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Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 45

ANNEX B

Distributor Regulation

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Change of Ownership

Center for Drug Regulation and Research 46

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
  • 6. Self-Assessment Toolkit
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Transfer of Location

Center for Drug Regulation and Research 47

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

Center for Drug Regulation and Research 48

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

Center for Drug Regulation and Research 49

C 1. Change only in the business name

  • 2. No transfer of location or change of ownership.

D

  • 1. Letter of Request for Change
  • 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

Center for Drug Regulation and Research 50

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

  • 1. Letter of Request for Change
  • 2. Application Form
  • 3. Contract Agreements to prove activity
  • 4. Proof of payment
  • 5. Self-Assessment Toolkit
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Zonal Change

Center for Drug Regulation and Research 51

C change of the name/number of the street/building without physical transfer of the establishment. D

  • 1. Letter of Request for Change
  • 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

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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

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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

Center for Drug Regulation and Research 54

C deletion of any approved/added distributor activity D

  • 1. Letter of Request for Change
  • 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

Center for Drug Regulation and Research 55

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

Center for Drug Regulation and Research 56

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

Center for Drug Regulation and Research 57

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

Center for Drug Regulation and Research 58

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

Center for Drug Regulation and Research 59

Situation 4: (1 Variation) PRIME Corporation was issued an initial LTO as Drug Distributor – Exporter on 30 April 2014 with an

  • pening 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

Center for Drug Regulation and Research 60

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

Center for Drug Regulation and Research 61