Consequential Amendment to the Fees in Respect of Drugs and Medical Devices Order – Closed Consultation

From Health Canada

A change was proposed to the definition of "new active substance" in the Fees in Respect of Drugs and Medical Devices Order to match a proposed definition change in the Food and Drug Regulations for "innovative drug" that was previously consulted on under the Regulations Amending the Food and Drug Regulations (Improving Access to Generics). Stakeholders were invited to comment on the amended definition for "new active substance".

Who was the focus of this consultation

We engaged with:

• Pharmaceutical sector

Goal of the consultation

Your ideas and inputs were sought on amending the definition of "new active substance" in the Fees Order to aligned with the proposed definition of "innovative drug" pursuant to the Access to Generics Regulations.

What we heard

Final reports

• No comments were received so no final report will be issued.

Related information

• Fees in Respect of Drugs and Medical Devices Order
• Regulations Amending the Food and Drug Regulations (Improving Access to Generics Regulations)
• Notice of Intent to consult on Health Canada's Order Amending the Fees in Respect of Drugs and Medical Devices

Contact us

Cost Recovery Office
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
250 Lanark Avenue, Graham Spry Building
Ottawa, ON K1A 0K9
A.L. 2004B

Telephone: 613-957-6690
Email: hc.cro-brc.sc@canada.ca