Quality overall summary: Veterinary drugs

The Quality Overall Summary (QOS) provides a condensed record of the key quality information in the veterinary drug submission. The document helps expedite the review process and facilitate the management of the lifecycle of the product.

A complete QOS should be submitted as a clean document in Word format at the time of filing New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) with Health Canada pursuant to Part C, Division 8 of the Food and Drug Regulations. If a section or field does not apply, this should be indicated by "Not applicable" or "N/A" in the appropriate area, with an accompanying explanatory note.

To obtain a copy or if you have questions about the template, email us directly at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

The key input fields of the template include:

• Summary of product information
• Reference product information (for generics only)
• Drug substance
• Drug product