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

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, 1 st 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 Center for Drug Regulation and Research 3

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

Republic of the Philippines Department of Health Food and Drug Administration A. OBJECTIVES OF THE MEETING Center for Drug Regulation and Research 5

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

Republic of the Philippines Department of Health Food and Drug Administration B. DRAFT REGULATION Center for Drug Regulation and Research 7

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation RATIONALE Center for Drug Regulation and Research 8

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 Center for Drug Regulation and Research 9

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation LTO APPLICATION Center for Drug Regulation and Research 10

A. Documentary Requirements (1) Application Form  Completely filled-up  signed by the authorized personnel  duly notarized Center for Drug Regulation and Research 11

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

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

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 Center for Drug Regulation and Research 14

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

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

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

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

A. Documentary Requirements (6) Proof of Payment • OR or payment slip Center for Drug Regulation and Research 19

A. Documentary Requirements (7) Self-assessment Toolkit Center for Drug Regulation and Research 20

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

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

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

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

C. Application for Variation 1. Major Variation a. Change of ownership b. Transfer of location Center for Drug Regulation and Research 25

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

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

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

D. Accessibility Forms – available at the FDA website Center for Drug Regulation and Research 29

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation EXEMPTION IN PROVIDING ANOTHER PHARMACIST FOR ADDITIONAL LICENSED ACTIVITY Center for Drug Regulation and Research 30

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) Center for Drug Regulation and Research 31

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 Center for Drug Regulation and Research 32

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation RESPONSIBILITIES OF IMPLEMENTING OFFICES Center for Drug Regulation and Research 33

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 Center for Drug Regulation and Research 34

LGUs  Enjoined in monitoring licensed establishments  Report to FDA any violative establishments Center for Drug Regulation and Research 35

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation TRANSITORY PROVISIONS Center for Drug Regulation and Research 36

Transitory Provision Submitted upon renewal for existing establishments  RMP  GPS Coordinates Center for Drug Regulation and Research 37

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation REPEALING/ SEPARABILITY CLAUSE Center for Drug Regulation and Research 38

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation EFFECTIVITY Center for Drug Regulation and Research 39

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation ANNEX A Center for Drug Regulation and Research 40

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

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

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

Voluntary Cancellation 1. Letter of Request 2. Original LTO Center for Drug Regulation and Research 44

Republic of the Philippines Department of Health Food and Drug Administration Distributor Regulation ANNEX B Center for Drug Regulation and Research 45