New & Abbreviated Drug Submissions (NSA/ABDS)
When a veterinary drug is already approved and currently being sold on the Canadian market, a licence holder that wants to implement a change must submit a Supplemental New Drug Submission (SNDS) or Notifiable Change (NC). SNDS are filed when the change to a NDS or ANDS is significant, whereas, a NC is filed when a minor or insignificant change needs to be adjusted. NC submissions are approved via a letter of no objection and are subject to a 90-day target-performance timeline.
Notices of Compliance (NOC) are issued to a manufacturer following approval of a market authorization for a NDS or ANDS. This letter is issued when the manufacturer has met Health Canada’s regulatory requirements for safety, efficacy and quality of the approved product.
Our team of veterinary experts have pioneered the regulatory process and can help your company files both NDSs and ANDSs as well as changes to any existing CRP. Our team will breakdown the guidance requirements and spearhead the filing including nay follow-up communications with Health Canada.