Guidance document on submission information for biologic drugs (Division 4, Schedule D): References, contacts
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References
Guidance documents
This guidance document refers to 4 Health Canada guidance documents. Sponsors should refer to the most up-to-date versions of these 4 references.
The documents are listed alphabetically, followed by the regulation to which they are relevant:
- Good manufacturing practices guide for drug products (GUI-0001) for C.04.004
- Guidance document - Post-notice of compliance (NOC) changes: Quality document (refer to Appendix 3) for C.04.004 and C.04.006
- Guidance for sponsors: Lot release program for Schedule D (biologic) drugs for C.04.007 and C.04.008
- Guidelines for environmental control of drugs during storage and transportation (GUI-0069) for C.02.012.1
Legal references
Food and Drugs Act
Schedule D in the Food and Drugs Act sets out biologic drugs.
Food and Drug Regulations
Division 4 in Part C of the Food and Drug Regulations (FDR) sets out regulations that are specific to biologic drugs.
- For the official version of all new and revised regulations explained in this Guidance document (such as Division 4, Division 2, and Division 8), refer to the Food and Drug Regulations.
- For the official version of the regulation amending the FDR, refer to Canada Gazette Part II, Date 2024-12-18, Volume 158, Number 26, titled Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing).
Contacts
The contact information is correct at the time of writing and may change over time.
Drug submissions
Office of Regulatory Affairs (ORA)
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Health Products and Food Branch (HPFB)
Health Canada
100 Eglantine Driveway
Tunney’s Pasture
Ottawa ON K1A 0K9
Email: brdd.ora@hc-sc.gc.ca
Telephone: 613-957-1722
Teletypewriter (TTY): 1-800-465-7735 (for people who have a hearing or speech impairment)
This guidance document
Centre for Policy, Pediatrics and International Collaboration (CPPIC)
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Health Products and Food Branch (HPFB)
Health Canada
100 Eglantine Driveway
Tunney’s Pasture
Ottawa ON K1A 0K9
Email: brdd-cppic_brdd-cppci@hc-sc.gc.ca
Teletypewriter (TTY): 1-800-465-7735 (for people who have a hearing or speech impairment)
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