ANNEX C  
 
Procedure and Requirements for Recall Termination  
 
A. Activities required and documents to be submitted to support the request for  termination:  
 
1. Where destruction is deemed necessary, whether actual health products or labelling 
materials  
 
a. Before the destruction, coordination with the FDA PRC shall be made to request for 
the presence of an FDA -authorized representative no later than one (1) week prior 
the activity.  
 
b. After the destruction activity, the MAH shall submit the following  documents:  
 
i. Notarized final report on the final disposition of the recalled product;  
ii. Certificate of Destruction issued by a Department of Environment and 
Natural Resources (DENR) accredited third party waste treatment  facility;  
iii. Photographs of the whole destruction activity covering even the transport of 
stocks meant for destruction;  and, 
iv. Copy of the signed FDA inspection report of destruction, signed by all 
relevant officers during the actual  destruction.  
 
2. Where the health product is to be  redressed:  
 
a. Before redressing, the MAH shall secure an approval from the FDA PRC. The MAH 
shall  likewise  coordinate  with the FDA  PRC  to request  for the inspection  of the 
product to check its compliance with its registered specifications. The conduct of 
redressing shall be in accordance with applicable Good Manufacturing Practices 
(GMP) requirements.  
 
b. The following documents shall be submitted to support the request for  termination:  
 
i. Notarized final report on the final disposition of the recalled product;  
ii. Copy of the signed FDA inspection report of  redressing;  
iii. Submission of actual labelling material;  and 
iv. Standard Operating Procedure (SOP) for  redressing.  
 
3. Where the MAH intends to return the affected health products to the country of origin : 
 
a. Before returning the products to the country of origin , the MAH shall secure 
approval from the FDA PRC. The MAH shall likewise coordinate with the FDA 
PRC to request for the presence of an FDA -authorized representative no later than 
one (1) week prior the inventory, sealing and packing of recalled  products.  
 
b. The following documents shall be submitted to support the request for termination, 
within fifteen (15) calendar days upon receipt of  concession:    
 i. Notarized final report on the final disposition of the recalled product;  
ii. Copy of the signed FDA inspection report;  and 
iii. Documents indicating the fulfilment of the returned  shipment.  
 
B. After submission of the final status report and additional documentation, the FDA PRC 
shall conduct a review to determine that all efforts have been made to remove or  correct the 
health product in accordance with the recall strategy, and when it is  to assume that the 
product subject to the recall has been removed and proper disposition has been made 
commensurate with the degree of hazard of the recalled  product.  
 
1. If the FDA PRC determines that the recall has been completed, a termination letter to 
that effect shall be issued to the MAH indicating such. The FDA may deploy  the FROO 
to further verify the status of recall completion. The FDA may further issue updates on 
the status of recalls  on FDA PRC as deem ed necessary.  
 
2. If the FDA PRC determines that recall has not been satisfactorily completed, notice and 
further advice shall be provided to the MAH. The FDA shall not be precluded from 
undertaking any further regulatory action to ensure the effectiveness of  recall.