Veterinary drugs - Management of regulatory submissions guidance: Appendices

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• Appendix A: Performance targets for veterinary drug submissions
• Appendix B: Contact information
• Appendix C: Definitions

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.