Regulatory Initiative: Fees in Respect of Drugs and Medical Devices Regulations - Exempting EUND Submissions and API Activities - Forward Regulatory Plan 2012-2014

Title or working title of the regulatory initiative: Fees in Respect of Drugs and Medical Devices Regulations - Exempting EUND Submissions and API Activities

Description of the objective:
Newer regulatory activities related to drugs in support of emergency measure (Extraordinary Use New Drugs (EUND)) and Active Pharmaceutical Ingredients (API) were not included (nor intended to be) within the scope of the User Fees Proposal as presented by Health Canada to stakeholders and Parliament in 2007. Proposed amendments to Fees in Respect of Drugs and Medical Devices Regulations are needed to explicitly exempt activities related to EUND and API from the scope of Health Canada's User Fees Proposal.

Enabling Act:
Food and Drugs Act

Indication of business impacts:
There are no expected business impacts.

Public consultation opportunities:

Information on previous consultations and details on upcoming opportunities for consultation will be provided on the Health Canada Website for Regulatory Modernization.

Canadians have the opportunity to provide input during the  Canada Gazette, Part I public comment period, currently open until March 7, 2013.

Departmental contact:

David K. Lee
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone number: 613-946-6586

Email address: LRM-MLR@hc-sc.gc.ca

For More Information

•  Government-Wide Forward Regulatory Plans
• The  Cabinet Directive on Regulatory Management
• The  Red Tape Reduction Action Plan
• The  Canada-United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the  Canada Gazette and  Consulting with Canadians websites.