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11 September 2019
On 28 June 2019 Health Canada released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling.
Health Canada has also released an updated Good Label and Package Practices Guide for Prescription Drugs. The 21 June 2019 update introduces only administrative edits to the 2016 guidance on the labelling and packaging of prescription pharmaceuticals, biologics and radiopharmaceuticals under Health Canada's Plain Language Labelling Initiative.
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