Submitting risk management plans guidance document: Resources

Submission process and content

• Filing submissions electronically
• Guidance document: Product monograph
• Fees for the review of drug submissions and applications
• Guidance document for industry – Review of drug brand names
• Guidance document: Labelling of pharmaceutical drugs for human use
• Post-notice of compliance (NOC) changes: Safety and efficacy document
• Guidance for industry: Management of drug submissions and applications
• Preparation of drug regulatory activities in the common technical document (CTD) format

Pharmacovigilance and other practices and standards

• Reporting adverse reactions to marketed health products
• Good pharmacovigilance practices (GVP) guidelines (GUI-0102)
• Labelling requirements for non-prescription drugs guidance document
• Good label and package practices guide (GLPPG) for prescription drugs
• Draft guidance document – The use of foreign reviews by Health Canada
• Notifying Health Canada of foreign actions – Guidance document for industry
• Good label and package practices guide for non-prescription drugs and natural health products
• Guidance document – Submission and information requirements for extraordinary use new drugs (EUNDs)
• Preparing and submitting summary reports for marketed drugs and natural health products – Guidance document for industry
• Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products - Guidance for industry
• Notice: Adoption of the International Conference on Harmonisation (ICH) guidance on periodic benefit risk evaluation report – ICH topic E2C(R2)
• Notice: Implementation of risk management planning including the adoption of International Conference on Harmonisation (ICH) guidance  Pharmacovigilance planning – ICH topic E2E

International Conference on Harmonization (ICH) guidance documents

Find the following guidance documents by accessing the International Conference on Harmonization (ICH) website:

• ICH E2C-R2: Periodic benefit-risk evaluation reports (PBRERs)
• ICH E2E: ICH harmonized tripartite guideline: Pharmacovigilance planning E2E

European Medicines Agency guidelines

Find the following guidelines by accessing the European Medicines Agency (EMA) website:

• Guidance on format of the risk management plan in the EU – in integrated format
• Guideline on good pharmacovigilance practices: Module V – Risk management systems