Radiopharmaceuticals, Kits, and Generators – Submission Information for Schedule C Drugs: Draft Guidance Document for Consultation

NOTICE TO STAKEHOLDERS

Release of draft Guidance document for consultation:
Radiopharmaceuticals, Kits, and Generators - Submission Information for Schedule C Drugs

Health Canada announces the release of the draft Guidance document Radiopharmaceuticals, Kits, and Generators - Submission Information for Schedule C Drugs for a 60-day consultation period from June 26 to August 26, 2018 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The objective of the draft Guidance document is to indicate data that sponsors should provide as part of submissions for Schedule C drugs.

PROCESS TO PARTICIPATE IN CONSULTATION

1. Obtain document

To obtain the document, please email hc.bgtd.opic-bpci.dpbtg.sc@canada.ca.

You will receive:

• the draft Guidance; and
• the form in which to submit your comments.

2. Submit comments

To submit comments to Health Canada:

• Please email comments to hc.bgtd.opic-bpci.dpbtg.sc@canada.ca using the form provided. All comments will be considered in the finalization of the document. The 60-day consultation period is from June 26 to August 26, 2018 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