Notice to Stakeholders - Release of draft Guidance document for consultation: Submission Information for Human-Use Biologic Drugs Derived from Plant Molecular Farming (PMF)

December 17, 2012

Health Canada announces the release of the draft Guidance document Submission Information for Human-Use Biologic Drugs Derived from Plant Molecular Farming (PMF) for a 75-day consultation from December 17, 2012 to March 18, 2013 inclusive. Health Canada invites all interested stakeholders to submit their feedback during this comment period.

The objective of the draft Guidance document is to indicate data that sponsors should provide as part of submissions for PMF-derived drugs in Canada.

Process to participate in consultation

1. Obtain document

To obtain the document, please email BGTD.OPIC@hc-sc.gc.ca.

You will receive:

• the draft Guidance;
• the form in which to submit your comments by section number and line number; and
• a supplementary question to answer.

2. Submit comments

To submit comments to Health Canada,

• Please email comments to BGTD.OPIC@hc-sc.gc.ca using the form provided. All comments will be considered in the finalization of the document. The 75-day consultation period is from December 17, 2012 to March 18, 2013 inclusive.

• Comments will also be accepted by:

  Fax
  (613) 952-5364

  Mail
  Office of Policy and International Collaboration
  Biologics and Genetic Therapies Directorate
  Health Products and Food Branch
  Health Canada
  Address Locator: 0702B
  200 Tunney's Pasture Driveway
  Ottawa ON K1A 0K9
  Canada