Canada Gazette Part I – Biologics, Radio-pharmaceuticals & Genetic Therapies

The following proposed regulatory amendments and Regulatory Impact Analysis Statement (RIAS) were recently pre-published in the Canada Gazette Part I for public consultation. Readers are invited to provide comments on these proposals within the time period specified. Comments received will be considered in drafting the final regulatory amendments and addressed in the RIAS for final publication in the Canada Gazette, Part II. Once approved by the Governor General in Council, the regulatory amendment and RIAS will be published in the Canada Gazette, Part II and come into force on the date or time period stated in the regulation.

• Proposed Blood Regulations
  Date of publication: March 10, 2012
  Comment period ends: May 24, 2012
• Regulations Amending Schedule D to the Food and Drugs Act (Blood)
  Date of publication: March 10, 2012
  Comment period ends: May 24, 2012
• Regulations Amending the Food and Drug Regulations (Blood)
  Date of publication: March 10, 2012
  Comment period ends: May 24, 2012
• Regulations Amending the Food and Drug Regulations (1319 - New Drugs for Extraordinary Use)
  Date of publication: April 3rd, 2010
  Comment period ends: June 18th, 2010
• Regulations Amending the Patented Medicines (Notice of Compliance) Regulations
  Date of publication: April 3rd, 2010
  Comment period ends: June 18th, 2010