S(A)NDS Template
The name or entity under which the drug submission is filed
What is the Sponsor/Manufacturer?
Found in Mod 1.0.1
What is the Cover Letter?
Mod 3 structure, the "S" and "P" stand for this
What is Drug "Substance" and Drug 'Product"?
A change in DS manufacturer
What is a C&M Only?
RPMD
What is the Regulatory Project Management Division?
This table is required for supplemental C&M submissions
What is the Summary of Post-Notice of Compliance Quality Changes table?
Found in Mod 1.3.1
What is the Product Monograph?
P.8
What is DP "Stability"?
A change to add a nitrosamine test to the DP specifications
What is C&M Only?
PDD
What is the Pharmaceutical Drugs Directorate?
This letter allows a sponsor to reference confidential business information from a Master File
What is a Letter of Access?
Found in Mod 1.3.6
What is the CPID?
P.7
What is the Container Closure System?
A new solid oral strength supported by a biostudy
What is Comp/C&M?
MHPD
What is the Marketed Health Products Directorate?
These "studies" may be provided as bioavailability, clinical, pharmacodynamics or pharmacokinetic
What are comparative studies?
Found in Mod 1.2.6
What are Letters of Access / Authorization
R.1.1
What is Executed Production Documents?
A new parenteral strength supported by a biowaiver
What is a C&M/LABELLING?
PDQD
What is the Prescription Drugs Quality Division?
This Canadian specific document provides a condensed summary of key Quality information
What is the CPID?
Found in Mod 1.4.2
What is the CS:BE?
P.2
What is the Pharmaceutical Development?
Change in the storage conditions for diluted or reconstituted product
What is a C&M/LABELLING?
IVIVC
What is in-vivo, in-vitro correlation?