Radiopharmaceuticals, Kits, and Generators – Submission Information for Schedule C Drugs: Draft Guidance Document for Consultation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Release of draft Guidance document for consultation: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Health Canada announces the release of the draft Guidance document Radiopharmaceuticals, Kits, and Generators - Submission Information for Schedule C Drugs for a 60-day consultation period from June 26 to August 26,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The objective of the draft Guidance document is to indicate data that sponsors should provide as part of submissions for Schedule C drugs.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 firstname.lastname@example.org.
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- the draft Guidance; and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 email@example.com 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:
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Address Locator: 0702B
200 Tunney’s Pasture Driveway
Ottawa ON K1A 0K9
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