Health Canada released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs on June 28, 2019, effective immediately. Revisions include clarifying additions on the requirements for cross-licensed products for an Administrative Certification Form and Letter of Authorization, a Drug Notification form and labelling.
Health Canada has also released an updated Good Label and Package Practices Guide for Prescription Drugs. The June 21, 2019 update introduces only administrative edits to the 2016 guidance on labelling and packaging of prescription pharmaceuticals, biologics, and radiopharmaceuticals under Health Canada’s Plain Language Labelling Initiative.
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