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Management of Applications and Performance for Drug Establishment Licences (GUI-0127) Download the alternative format (PDF format, 1.6 MB, 34 pages) Organization: Health Canada or Public Health Agency of Canada Published: 2020-03-18 Date issued: November 27, 2019 Date…

Drug Establishment Licence application form (FRM-0033) FRM-0033 instructions PDF Version For best results, download and fill this form in a PDF reader Application Information Table 1. Drug establishment licence information (existing DEL holders only) Drug Establishment Licence…

Guidance on Drug Establishment Licences (GUI-0002) Drug Establishment Licence Application Forms and Instructions (FRM-0033) Fees for the Review of Human and Veterinary Drug Establishment Licence Applications Management of Applications and Performance for Drug Establishment…

Drug establishment licence (for human use) and associated fees Fees for examination of an application for an establishment licence: drugs for human use as of April 1, 2026 Item Name of fee Fee as of April 1, 2025 Fee as of April 1, 2026 1 Fabrication - sterile dosage form $49,558…

ARCHIVED Guidance document - Management of Disinfectant Drug Applications Notice to Reader: This is an archived document. For a current version, refer to our summary on guidance documents for disinfectants . Date adopted: January 2018 Date posted: 2019/11/08 Effective date:…

Fees for the examination of a submission: drugs for human use Fees for the examination of a submission: drugs for human use as of April 1, 2026 Item Submission class Description Fee as of April 1, 2025 Fee as of April 1, 2026 1 New active substance Submissions in support of a…

Priority Review of Drug Submissions (Therapeutic Products) (PDF Version - 16 K) Contact: Policy Bureau Enquiries What is Priority Review? Priority Review is a fast-track status granted to eligible new drug submissions for human use, following review and approval of a request…

Special Access Programme - Drugs Contact: SAP Drugs What is the Special Access Programme? The Special Access Programme ( SAP ) allows practitioners to request access to drugs that are unavailable for sale in Canada. This access is limited to patients with serious or…

Casodex 150 mg Fact Sheet (PDF Version - 13 K) Contact: BMORS Enquiries Important Safety Information - Accelerated deaths in localized prostate cancer patients, undergoing watchful waiting and therapy with Casodex ® 150 mg. This fact sheet notifies the Canadian public on the…

Notice of Compliance with Conditions - NOC/c (Therapeutic Products) (PDF Version - 101 K) Contact: Policy Bureau Enquiries What is a Notice of Compliance with Conditions (NOC/c)? An NOC/c is authorization to market a drug that is issued under the Notice of Compliance with…