ARTICLE
1 February 2018

Consultation On The Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product

SB
Smart & Biggar

Contributor

Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
On December 18, 2017, Health Canada published a Notice soliciting comments and recommendations from stakeholders regarding potential changes to its Guidance Document...
Canada Food, Drugs, Healthcare, Life Sciences

On December 18, 2017, Health Canada published a Notice soliciting comments and recommendations from stakeholders regarding potential changes to its Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product. The Guidance, which took effect November 24, 2017 (previously reported), is directed to sponsors of all Abbreviated New Drug Submissions or Abbreviated Extraordinary Use New Drug Submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed in a country other than Canada (i.e., under the Canadian Reference Product definition provided in paragraph (c) of section C.08.001.1 of the Food and Drug Regulations). Stakeholder feedback, preferably in electronic form, should be submitted to Health Canada by March 18, 2018.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More