Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026): References

On this page

• Legislation
• Health Canada GMP guidance documents
• International guidance documents
• Other related documents

Legislation

• Food and Drugs Act
• Food and Drug Regulations

Health Canada GMP guidance documents

• Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
• Annex 3B to the Good manufacturing practices guide – Positron-emitting radiopharmaceuticals (GUI-0071)
• Good manufacturing practices guide for drug products (GUI-0001)
• Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104)
• Guidance on drug establishment licences (GUI-0002)
• Importing and exporting health products for commercial use (GUI-0117)

International guidance documents

• International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products
• Guide for good manufacturing practice for medicinal products – Annex 3 – Manufacture of radiopharmaceuticals (Pharmaceutical Inspection Cooperation Scheme (PIC/S))
• Guidelines to good manufacturing practice medicinal products for human and veterinary use: Annex 3: Manufacture of radiopharmaceuticals (European Commission)

Other related documents

• Canadian Nuclear Safety Commission (CNSC)
• GD-52: Design guide for nuclear substance laboratories and nuclear medicine rooms (CNSC)