Veterinary drugs - Management of regulatory submissions guidance: Appendices

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Appendix A: Performance targets for veterinary drug submissions
Activity Type Submission Type Performance Target in Calendar Days (VDD) Performance Target in Calendar Days (Sponsor) Comments
Pre-submission meeting request Pre-submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, protocol review)
Not applicable At least 60 prior to the proposed meeting date Not applicable
Pre-submission meeting package Pre-submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, protocol review)
Not applicable As specified by VDD in meeting confirmation Not applicable
Draft pre-submission meeting minutes Pre-submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, protocol review)
Not applicable 14 Not applicable
Review of draft pre-submission meeting minutes Pre-submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, protocol review)
21 Not applicable Not applicable
Screening NDS, ANDS, SNDS, SANDS 45 Not applicable INDs and protocol reviews are verified for administrative completeness only
NC, DIN, change to DIN, administrative submissions 14
ESC/ ESC amendment 7
IND, protocol review Not applicable
Issuance of SDN NDS, ANDS, SNDS, SANDS, Administrative new drug submissions, protocol review, DIN, administrative DIN, change to DIN Not applicable 45 Once administratively complete, deficiencies for administrative submissions will be addressed during review.
Protocol Reviews will not be scientifically screened and will either be accepted for review once administratively complete or rejected if the submission does not qualify as a protocol review.
NC, ESC, ESC amendment Not applicable 30
Screening of response to SDN NDS, ANDS, SNDS, SANDS, NC, DIN 14 Not applicable Not applicable
ESC 7
Issuance screening acceptance letter NDS, ANDS, SNDS, SANDS, administrative new drug submissions, protocol review, DIN, administrative DIN, change to DIN, NC, ESC, ESC amendment Not applicable Not applicable Not applicable
Issuance of SRN NDS, ANDS, SNDS, SANDS, administrative new drug submissions, protocol review, DIN, administrative DIN, change to DIN, NC, ESC, ESC amendment Not applicable Not applicable If the sponsor decides to refile this submission at a future time, it will processed as a new submission.
Issuance of clarification request NDS, ANDS, SNDS, SANDS, administrative new drug submissions, IND, protocol review, DIN, administrative DIN, change to DIN, NC, ESC, ESC amendment Not applicable As indicated in clarification request Not applicable
Issuance NOD NDS, ANDS, SNDS, SANDS, administrative new drug submissions, DIN, administrative DIN, change to DIN Not applicable 90 Not applicable
NC, ESC, ESC amendment, protocol review Not applicable 30
Screening of response to NOD NDS, ANDS, SNDS, SANDS, administrative new drug submissions, DIN, administrative DIN, change to DIN, NC, ESC, ESC amendment Same as for initial submission Not applicable Not applicable
Review of initial submission NDS, ANDS 300 Not applicable Not applicable
SNDS, SANDS 240
NC 90
Administrative NDS/ANDS/SNDS/SANDS 90
Protocol review, ESC/ ESC amendment, IND/IND amendment 60
DIN/administrative DIN/change to DIN 120
Review of response to NOD (second review cycle) NDS, ANDS 150 Not applicable Not applicable
SNDS, SANDS 120
DIN, administrative DIN, change to DIN, NC, ESC, ESC amendment, protocol review 60
Administrative NDS/ANDS and administrative SNDS/SANDS 45
Appendix B: Contact information
Subject Contact Address
All submission-related documents and requests except for product classification requests E-mail: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Product classification requests E-mail: classification-vet@hc-sc.gc.ca
Regulatory Enrolment Process (REP) E-mail: eReview@hc-sc.gc.ca

Appendix C: Definitions

Administrative submissions:
a submission that does not require scientific review. Includes NDS, ANDS, SNDS, SANDS, NC submission types.
Amendment to an ESC:
the request to amend an approved ESC, for example, require more drug product; change in study location; change in investigator.
Drug identification number (DIN):
an 8-digit numerical code assigned to each drug product.
Experimental studies certificate (ESC) submission:
information and material to support the issuance of an experimental studies certificate for a drug to be administered to either a food or non-food producing animal.
Investigational new drug (IND) submission:
a preclinical submission filed pursuant to Section C.08.005 of the Food and Drug Regulations.
Manufacturer:
company to whom the DIN number was assigned to for a given drug product.
Protocol review:
the request for the review of scientific information outside of a regular drug submission (that is, review of a proposed trial protocol).
Review:
the period from the time a submission is accepted for review to the time when a decision is made on that submission.
Screening:
the period from the time an administratively complete submission is received in the VDD to the time when a screening decision is made on that submission (also referred to as preliminary examination).
Sponsor:
the applicant who filed a drug submission with the VDD.
First review cycle:
the period during which the original submission is under review.
Second review cycle:
the period during which the response to a notice of deficiency is under review.
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