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
