Guidance on the Food and Drug Regulations for public health emergency drugs: References, key contacts

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References

Authorization applications

General

Safety and efficacy

Quality

Labelling

COVID-19 drugs

COVID-19 vaccines

Establishment licensing

Good manufacturing practices

Good laboratory practices

Post-market vigilance

Post-notice of compliance (NOC) changes

Advertising webpages

Disinfectants guidance documents and monograph

Non-prescription pharmaceuticals and hand sanitizer (antiseptic skin cleansers)

Key contacts

To help ensure that we prioritize your inquiry, please include "public health emergency drug" in the subject line of your email.

Biologic and Radiopharmaceutical Drugs Directorate
Office of Regulatory Affairs
Email: brdd.ora@hc-sc.gc.ca

Pharmaceutical Drugs Directorate
Regulatory Project Management Division
Email: rpmd-dgpr@hc-sc.gc.ca

Veterinary Drugs Directorate
Submission and Knowledge Management Division
Email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Natural and Non-prescription Health Products Directorate
General enquiries
Email: nnhpd-dpsnso@hc-sc.gc.ca,

For application format-related inquiries:

Office of Submissions and Intellectual Property
Email: ereview@hc-sc.gc.ca

For adverse reaction reporting-related inquiries:
Canada Vigilance Program (CVP)

For inquiries about good manufacturing practices (GMP) compliance requirements:

Email: GMP_Questions_BPF@hc-sc.gc.ca

For drug establishment licensing (DEL)-related inquiries:

Email: del.questions-leppp@hc-sc.gc.ca

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