Guidelines on the Implementation of New Rules and ... Licensing...For single proprietorship - Certificate of ... • Barangay • city ... Application Form 3. Updated Site Master File

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 Manufacturer and its Subclass (Packer/

Repacker/ Trader) 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

Manufacturer 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




For other qualified personnel

• CV

• Training records to prove qualification




Qualified personnel

• production manager

• quality assurance manager

• quality control manager

• authorized person for batch release



(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) Site Master File

• Based on PIC/s GMP



(7) Proof of Payment

• OR or payment slip



(8) Self-assessment Toolkit


B. Evaluation and Compliance to cGMP

(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

• Contract 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


C. Application for Variation

1. Major Variation

a. Change of ownership

b. Additional product line

c. Transfer of location

d. Change of activity



2. Minor Variation-Prior Approval

a. Change of business name

b. 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 Manufacturer-Repacker and Drug Manufacturer-Trader pharmacist to handle another non-manufacturing activity except retailing 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 Manufacturer-Repacker and Drug Manufacturer-Trader pharmacist to handle another non-manufacturing activity except retailing 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. Site Master File

7. Proof of Payment

8. Self-Assessment Toolkit


Renewal LTO Application

1. Application Form

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

3. Proof of Payment (e.g., Official receipt or Landbank On-Coll payment slip)



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


Additional Production Line


C Additional production line inside the manufacturer

D


2. Application Form

3. Updated Site Master File

4. 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


6. Proof of payment


Change of Activity


C 1. Additional activity engaged by the manufacturer (e.g. LTO as

Manufacturer-Repacker with additional activity as

Manufacturer)

2. Change from the initially licensed activity (e.g. LTO as

Manufacturer-Repacker to Manufacturer-Packer).

D


2. Application Form


4. 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


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 manufacturing

activity

D


2. Application Form

3. Termination of contract or conformance letter

4. Proof of payment





Situation 1

MMZ Manufacturing, Inc. with an existing and valid LTO (CDRR-RIV-DM-123) wishes to transfer their ownership rights to ESM Laboratories, Inc. due to financial crisis.




Situation 2:

Company ABC holds an existing and valid LTO (CDRR-RIII-DM-001) as Repacker located at 401 Industrial Park, San Vicente, Bulacan. Since the business is doing well, the said company wants to venture manufacturing of its own product.




Situation 3:

JST Pharmaceuticals, a well-known manufacturer of generic medicines currently located at No. 5 Saint. James St., Brgy.,Ilaya, Zone 4, Dasmariñas, Cavite will change its address to No. 5 Saint. James St., Brgy.,Ilaya, Zone 3, Dasmariñas, Cavite due to unavoidable circumstance mandated by municipality.




Situation 4:

Amethyst Labs. Corp., is a holder of a newly issued LTO as Drug Manufacturer located at Laguna. Expanding its business, the management decided to relocate to a bigger place and replace its business name to One World Laboratories while retaining the current owners. Due to these major changes, their Registered Pharmacist decided to leave.




Situation 5:

Company EFG is an existing manufacturing establishment with valid LTO located at Cavite and currently into processing of non-penicillin products. During the validity of LTO the company wants to widen its scope as a manufacturer and will try to engage in processing penicillin related products.




Situation 6:

Cigna Laboratories located in 706 Industrial Rd., San Miguel Bulacan has an existing LTO as Drug Manufacturer (CDRR-NCR-DM-101) with validity until 30 September 2014. Due to inavoidable circumstance, the pharmacist-in-charge filed her resignation.




Situation 7:

Leo Manufacturers currently owned by the Monreal Group of Companies has a valid and existing LTO as Packer-Repacker. Due to a controversy, its clients started to terminate their contracts. Due to this incident, to maximize the remaining resources and to cover up for their losses, the company decided to stop their repacking activity and would just remain as a packer.




Documents

Guidelines on the Implementation of New Rules and ... Licensing...For single proprietorship - Certificate of ... • Barangay • city ... Application Form 3. Updated Site Master File