BFAD USE ONLY

RSN :
Registration Number:
OR Number:
Amount:
Date Received:
Annex D
BUREAU OF FOOD AND DRUGS
PRODUCT SERVICES DIVISION DRUG SECTION
BFAD-PSDD Form
Generic Name:
Brand name:
Applicant Company
Manufacturer Repac!er:
"mporter Distributor #rader:
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PART II (BFAD Use)
I. Pre-Assessment
A$
Received Compliant
Non%
Compliant
Remar!s
Documentary Reu!rements
&$ Revised Assessment slip
'$ Notari(ed Application )etter
*$ B+AD ,SDD +orm
-$ Copy of valid )icense to Operate
.$ Original copy of Certificate of ,roduct Registration
/$ Copy of certification of approval on post approval c0anges 1if
applicable2
Tec"n!ca# Reu!rements
&$ 3nattac0ed and readable specimen of all labeling materials per
pac! si(e 4 e$g$ outer5 immediate5 pac!age insert 1if applicable2 6
'$ Specimen of t0e finis0ed commercial product 1One specimen to
represent t0e different pac! si(e2
*$ Actual Studies 1* production batc0es2
$%D conta!n!n& t"e su'm!tte( reu!rements
Assessed By/ date:
II. Recommen(at!on
+inal 7valuation 1R7COMM7NDA#"ON2 8 Approval 8 Disapproval 7valuated by date:

Automatic Rene9al 7:port
PART I (%#!ent Use on#y)