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Change of Pharmacist or Other Qualified Personnel

FDA drug distributors form for change of pharmacist or other qualified personnel

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH
DRUG IMPORTER (

) / EXPORTER (

) / WHOLESALER (

)

SELF-ASSESSMENT TOOLKIT FORM
CHANGE OF PHARMACIST OR OTHER QUALIFIED PERSONNEL

COMPANY NAME
COMPANY ADDRESS
OWNER

:
:
:

NAME/POSITION OF
:
PREVIOUS EMPLOYEE
SERVICE ENDED
:
NAME OF NEW
:
EMPLOYEE
SERVICE BEGAN
:
LTO NUMBER
:
VALIDITY
:
Directions:
Fill out the form by ticking the applicable box. Provide remarks on the client’s column when necessary.
Submit in Portable Document Format (pdf) and word format duly signed by the pharmacist/owner.

DOCUMENTARY REQUIREMENTS:

Yes

No

REMARKS
CLIENT

FDA

1. Application Form for LTO
 Is the application properly filled out?
 Is it duly notarized?
 Are the signatories in the application form the authorized
persons as required under the following circumstances?
(a) If single proprietorship – the owner as registered in DTI
(unless there is a different authorized person)
(b) If partnership/corporation – one of the incorporators or
authorized person as indicated in the board resolution or
Secretary’s Certificate
(c) If cooperative – authorized person indicated in the
board resolution and/or Secretary’s Certificate of the
cooperative
If the signatory is not the owner or one of incorporators, as the
case may be:

Is the board resolution or Secretary’s Certificate notarized
and clearly identify the person authorized to sign for and in
behalf of the owner or corporation?








2. Credentials of the pharmacist or other qualified personnel
Is the responsible pharmacist identified?
Identify the name under client’s remarks
Is the PRC ID of the pharmacist-in-charge still valid?
If the PRC is not valid, is there a proof of renewal attached?
Is the resignation letter of the responsible pharmacist from
previous company signed/ conformed by the
owner/authorized representative of the establishment?
(where applicable)
 Is the LTO number of the previous company indicated?
Is the name of pharmacist in the certificate of attendance to

1

FDA seminar on licensing of establishment the same with
application form for LTO?
 Is the seminar attended corresponds to the type of LTO
applied by the establishment? If not yet attended, is proof of
registration of the scheduled licensing seminar from the FDA
Academy included?
Note: Credentials of the other qualified personnel (e.g. pharmacovigilance officer) will be checked upon inspection.
3. Proof of Payment
 Is the payment made according to the required fee?
 Is there a scanned copy of proof of payment (e.g FDA official
receipt, Landbank On-coll validated slip) submitted?
Note: If the following is/are not submitted in the initial application, the said document/s shall be attached:
 Risk Management Plan (RMP) or commitment letter while the official RMP framework from FDA is not yet issued
 GPS Coordinates
NOTE: ADDITIONAL DOCUMENTS MAY BE REQUIRED TO BE SUBMITTED AS DEEMED NECESSARY.
--- To be filled out by client: --Prepared by:
Signature:
Position (Pharmacist / Owner):
Date:
--- To be filled out by RFO: --Remarks:
Decision:
Approval
Denial
Clarification
Inspection
Evaluated by:
Date:

--- To be filled out by CDRR: --Decision:
Approval
Clarification
Evaluated by:

Remarks:

Date:

2
 
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