Scribd
Upload
268 views

Counterfeit Reporting Form

This counterfeit reporting form is used to document suspected counterfeit medicines. It collects information such as the date, medicine details, source of the suspected counterfeit, measures taken, and pharmacy/establishment details. The form follows SOPxxx and must be sent to the specified FDA office after completion to report suspected counterfeit medicines.

Uploaded by

dawn legaspi
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
268 views

Counterfeit Reporting Form

This counterfeit reporting form is used to document suspected counterfeit medicines. It collects information such as the date, medicine details, source of the suspected counterfeit, measures taken, and pharmacy/establishment details. The form follows SOPxxx and must be sent to the specified FDA office after completion to report suspected counterfeit medicines.

Uploaded by

dawn legaspi
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

Document No.

Fxxx-SOPxxx
COUNTERFEIT REPORTING FORM SOP No.: SOPxxx
Page 1 of 3
Initial Issue Date Revision Date Revision No. Implementation Date
DD-MM-YYYY DD-MM-YYYY 000 DD-MM-YYYY
Prepared by: Approved by:
Name & Signature Name & Signature
Designation Designation
Date: DD-MM-YYYY Date: DD-MM-YYYY

Direction(s):
 Please tick the respective box or
 Write details LEGIBLY as required

Date and Time:

 Prescription medicine
 Non-prescription medicine

Stage of supply:
 Distributor
 Wholesaler
 Hospital pharmacy
 Community pharmacy
 Others (please specify): _______________________________________________

Source of supply:
 Wholesaler
 Distributor
 Pharmacy
 Online Shops
 Open market
 Other source, (specify):__________________________________________________

Brand name:
Main active substance:
Strength:
Dosage form:
Package size:
Batch number:
Expiry date:

Is the medicine suspected to be counterfeit? or substandard?


 Counterfeit
 Substandard

Why is this medicine suspected to be counterfeit?

Alert is issued by government or industry


Strictly Confidential
Document No. Fxxx-SOPxxx
COUNTERFEIT REPORTING FORM SOP No.: SOPxxx
Page 2 of 3
Initial Issue Date Revision Date Revision No. Implementation Date
DD-MM-YYYY DD-MM-YYYY 000 DD-MM-YYYY
Prepared by: Approved by:
Name & Signature Name & Signature
Designation Designation
Date: DD-MM-YYYY Date: DD-MM-YYYY

 Yes
 No

What measures were taken to prevent the risk of possible harm by the suspected counterfeit?

What is the most likely source for the suspected counterfeit medicine?

What is the suspected country of origin of the counterfeit medicine?

Details from which the suspected counterfeit medicine has been seen and/or it is available

Pharmacist Details (if it is available in establishment such us Wholesaler/ Distributor/


Community Drugstore/ Hospital)
Name of Pharmacist (Write name in Full)
License Registration No.
Validity
Contact Number
Signature
Establishment Details
Name of the Establishment:
Address:
Classification of the Establishment Activity:
 Wholesaler
 Distributor
 Pharmacy
 Online Shops
 Open market
 Other source, (specify):__________________________________________________

Strictly Confidential
Document No. Fxxx-SOPxxx
COUNTERFEIT REPORTING FORM SOP No.: SOPxxx
Page 3 of 3
Initial Issue Date Revision Date Revision No. Implementation Date
DD-MM-YYYY DD-MM-YYYY 000 DD-MM-YYYY
Prepared by: Approved by:
Name & Signature Name & Signature
Designation Designation
Date: DD-MM-YYYY Date: DD-MM-YYYY

LTO No. (if FDA licensed)


Business Permit Reg. No.
DTI Reg. No.
Name of the Owner:

Please inform the FDA after accomplishing this form and send this form to which they told you to send
it.
FDAC No.:

( 8821 – 1159
( 8821 – 1162
( 8821 – 1176
( 8821 – 1177
( 8821 – 1220

Strictly Confidential

You might also like