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Additional Activity

FDA sponsor and CRO form for additional activity

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
SPONSOR (

) / CONTRACT RESEARCH ORGANIZATION (

)

SELF-ASSESSMENT TOOLKIT FORM
CHANGE OF ACTIVITY

COMPANY NAME
COMPANY ADDRESS

:
:

ADDITIONAL/CHANGED
ACTIVITY/IES
INITIALLY-APPROVED
ACTIVITY/IES

:
:

LTO NUMBER
:
VALIDITY
:
Directions:
Fill out the form by ticking the applicable column. Provide remarks on the client’s column when necessary.
Accomplish in duplicate copies.
REMARKS

DOCUMENTARY REQUIREMENTS:

Yes

No

CLIENT

FDA

1. Application Form
Is the application properly filled out?
Is it duly notarized?
Are the signatories in the application form the approving
authority and qualified person 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
If the signatory is not the owner or one of the 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?






Is the person identified in the said document the same
person who signed the Application Form and/or Contract/
Agreement?

2. Affidavit to Show Proof of Additional/Change in Activity/ies
 Is the change in activity clearly specified in the affidavit?
3. Proof of Payment
 Is the payment made according to the required fee?
Prepared by:
Position (Qualified Person / Owner):
Decision:
Approval

--- To be filled out by client: --Signature:
Date:
--- To be filled out by FDA Officer: ---

Remarks:

1

Denial
Clarification
Inspection

Evaluated by:

Date:

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

Remarks:

Date:

2
 
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