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This is in reference to the Memorandum on the pre-assessment and acceptance of applications for Lot Release Certification (LRC) dated 10 June 2020. Please be guided with the changes in schedule and inclusion of other types of applications as follows:

ONLINE SUBMISSIONS Schedule of receiving / processing
Online submission of soft copy through email ([email protected]) Hard copy submission at FDAC (after successful pre-assessment/advance review)
LR Application

 

FOR PRE-ASSESSMENT

Mondays TO Fridays

 

from 8:00AM

to 3:00PM

Mondays TO Fridays

 

from 9:00AM

to 2:00PM

Other applications/requests*

 

ADVANCE SUBMISSION

FOR REVIEW

 
WALK-IN SUBMISSIONS Hard copy submission at FDAC
LR Application

 

FOR PRE-ASSESSMENT

AND SUBMISSION

Mondays AND Fridays only

 

from 9:00AM

to 11:00AM

Other applications/requests*

 

FOR SUBMISSION

*i.e., Compliance, Additional Shipment, Amendment, among others

The online submission and the changes in schedule shall be available and in effect until further notice. This memorandum supersedes the one mentioned above, which can be viewed at https://www.fda.gov.ph/pre-assessment-and-acceptance-of-applications-for-lot-release-certification/. These changes shall also be incorporated in the soon to be released FDA Circular for the New Normal Operational Guidelines at FDAC.

For any inquiries or concerns, please do not hesitate to contact us through email or call us at +632 8 8571900 loc. 1261.

For your information and guidance.

Attachment:->Memorandum for Lot Release Certification