Drugs and Health Products

To find contact information for topics other than Drugs and Health Products, view the Main Contact Us page.

Choose any of these topics for contact information:

• Adverse Reaction Information
• Advisories, Warnings and Recalls
• Biologics, Radiopharmaceuticals & Genetic Therapies
• Compliance and Enforcement
• Controlled Substances & Precursor Chemicals
• Drug Products
• Funding and Fees
• MedEffect Canada
• Medical Devices
• Medical Use of Marijuana
• Natural and Non-prescription Health Products
• Public Involvement and Consultation
• Regulatory Requirements for Advertising
• Special Access to Drugs & Health Products
• Veterinary Drugs

Adverse Reaction Information

• Contact the Canada Vigilance Program for information on adverse reactions to the following health products marketed in Canada: pharmaceuticals, biologics (including fractionated blood products as well as therapeutic and diagnostic vaccines), natural health products and radiopharmaceuticals.
• Contact the Health Products and Food Branch Inspectorate for information about medical device problem reporting.
• Contact the Public Health Agency of Canada for information about vaccines.
• Report an Adverse Reaction to Health Canada via a toll-free telephone line or through a Canada Vigilance Regional Office
• Contact the Veterinary Drugs Directorate's Pharmacovigilance program to report adverse reactions to veterinary drugs.

Advisories, Warnings and Recalls

For information about advisories, warning and recalls related to:

• biologics and radiopharmaceuticals for human use contact the Biologics and Genetic Therapies Directorate.
• marketed health products contact the Marketed Health Products Directorate (MHPD).
• pharmaceutical drugs for human use contact the Therapeutic Products Directorate (TPD) .
• medical devices for human use contact the Medical Devices Directorate (MDD).
• natural health products contact the Natural Health Products Directorate (NHPD).
• veterinary drugs contact the Veterinary Drugs Directorate (VDD).

Biologics, Radiopharmaceuticals and Genetic Therapies

Contact the Biologics and Genetic Therapies Directorate for information about:

• Blood and blood products,
• Cells, tissues and organs,
• Genetic therapies and diagnostics,
• Radiopharmaceuticals
• Reproductive technologies,
• Viral and bacterial vaccines.

For more specific information contact the following offices:

• Centre for Biological Evaluation
• Office of Policy and International Collaboration
• Office of Regulatory Affairs

Compliance and Enforcement

Controlled Substances and Precursor Chemicals

Contact the Office of Controlled Substances for information on legislation, policy, activities, and the operations with regards to controlled substances and precursor chemicals.

Contact the appropriate DAS Contact Personnel for Police Forces for information on seized drug exhibit submissions.

Drug Products

• Therapeutic Products Directorate:
  • General enquiries
• Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
  • Clinical and Pre-clinical Reviews (prescription pharmaceuticals)
• Bureau of Gastroenterology Infection and Viral Diseases (BGIVD)
  • Clinical and Pre-clinical Reviews (prescription pharmaceuticals)
  • Non-prescription Drug Evaluations and Labelling
• Bureau of Metabolism, Oncology and Reproductive Science (BMORS)
  • Clinical and Pre-clinical Reviews (prescription pharmaceuticals)
• Bureau of Pharmaceutical Sciences (BPS)  
  • Clinical Comparative Bioavailability Data Evaluations (all pharmaceuticals)
  • Quality (Chemistry and Manufacturing) Reviews (all pharmaceuticals)
• Bureau of Policy Science and International Programs
  • Policy and Regulatory Development
  • International Cooperation and Harmonization
  • Science Advisory Committees
• Good Review Practices
• Office of Planning, Performance and Review Services (OPPRS)
  • Business Transformation Strategy
  • Planning and Administration
  • Regulatory Project Management
• Office of Clinical Trials
  • Clinical Trial Applications
  • Quality (Chemistry and Manufacturing) Reviews (for clinical trials)
• Office of Risk Management
  • Risk Management
  • Special Access Programme (drugs)
• Regulatory Affairs
• Regulatory Project Management (RPM) Division

Funding and Fees

• For information about Funding and Fees, specifically the Cost Recovery Initiative (CRI), contact the Policy, Planning and International Affairs Directorate.

MedEffect Canada

MedEffect Canada is a Health Canada initiative to provide centralized access to important new health product safety information and to build awareness on adverse reactions and the importance of reporting them.

We invite you to get involved!

• Write to the Marketed Health Products Directorate.
• Contact the MedEffect Canada Team.
• Contact the Canadian Medical Devices Sentinel Network.
• Contact the Canada Vigilance Program.
• Contact the Canada Vigilance - Medical Device Problem Reporting Program.
• Contact the Health Product InfoWatch Team.
• Contact your Canada Vigilance Regional Office for information or to report an adverse reaction.

We invite you also to:

• Report an adverse reaction
• Subscribe to MedEffect e-Notice or to MedEffect Canada RSS Feeds to receive marketed health product advisories for health professionals and the public as well as the most recent publication of the Canadian Adverse Reaction Newsletter.

Medical Devices

• Medical Devices Bureau
• Device Evaluation Division
• Device Licensing
• License Renewal

Medical Use of Marijuana

• For information about medical use of marijuana contact the Office of Medical Cannabis.

Natural and Non-prescription Health Products Directorate

General Enquiries

General enquiries regarding natural health products (NHPs), non-prescription drugs, product or site applications, licence status or corrections, etc., may be submitted to the Natural and Non-prescription Health Products Directorate (NNHPD), by email to nnhpd-dpsnso@hc-sc.gc.ca.

Methods of delivery

Contacts for Natural Health Products and Non-prescription Drugs

• Bureau of Consumer Health Product Modernization
  Enquiries on the development of the self-care framework may be submitted to:
  selfcareproducts-produitsautosoins@hc-sc.gc.ca.
• NNHPD Consultations
  To provide input into open stakeholder consultations, please contact:
  nnhpd_consultation_dpsnso@hc-sc.gc.ca
• Product Classifications Products are classified based on composition, representation, format, and public
  perception and history of use. Enquiries or requests may be submitted to:
  ingredient_support@hc-sc.gc.ca

Contacts for Non-prescription Drugs

• Product Licensing for Non-prescription Drugs
  For general enquiries relating to licensing non-prescription drugs, please contact the Natural and Non-prescription Health Products Directorate (NNHPD), by email to nnhpd-dpsnso@hc-sc.gc.ca.
• Drug Product Database
  To search for a licensed non-prescription product, please visit the online Drug Products Database (DPD).

  For general questions about the contents of the DPD, please contact: The Office of Submissions and Intellectual Property by email at: OSIP-BPPI@hc-sc.gc.ca or by phone at 613-941-7281.

  For technical support about the database, please contact: DPD Data Administrator

• Drug Establishment Licensing
  For general enquiries relating to licensing non-prescription drugs, please contact:
  del_questions_leppp@hc-sc.gc.ca. More information can be found at the Drug Establishment Licences site.
• Clinical Trials for Non-prescription Drugs
  For information, please contact: OCT_BEC_Enquiries_Enquetes@hc-sc.gc.ca

Contacts for Natural Health Products

• Product licensing for natural health products
  For general enquiries relating to licensing natural health products, please contact the Natural and Non-prescription Health Products Directorate (NNHPD), by email at nnhpd-dpsnso@hc-sc.gc.ca.
• Natural Health Products Online System
  To submit Trading Partner application packages electronically, or to report technical issues and/or errors with the NHP Online System (e.g. web forms/databases), please email: hc.nhp.initiative-psn.sc@hc-sc.gc.ca.
• Natural Health Products Ingredient Database (NHPID)
  The NHPID is a repository of scientific terminologies and pre-cleared information approved by the NNHPD. To request additions or modifications of ingredient information or controlled vocabulary to the database, please use the Issue Form and submit it to: ingredient_support@hc-sc.gc.ca.
• Clinical Trials for NHPs
  The NNHPD must authorize clinical trials for natural health products. The process of applying for authorization to conduct a clinical trial is designed to ensure the safety and ethical treatment of human experimental subjects and other persons involved in the trial. For further information, please contact: hc.nhpd-cta-dec-dpsn.sc@hc-sc.gc.ca.
• Site Licensing for NHPs
  Who requires a site licence?

  Note that applicants are strongly encouraged to enrol as Trading Partners and submit site licence applications (SLAs) via the secure email delivery service epost Connect (for more details, please refer to the "Methods of Delivery" section below) or as mentioned in the How to Interact with the Natural and Non-prescription Health Products Directorate Electronically. For more information, please contact: nnhpd-dpsnso@hc-sc.gc.ca

Methods of Delivery

Submissions must be sent via either through ONE of the following options:

• (1) regular postal delivery
• (2) courier
• (3) secure email service, ePost Connect (New NHP Applications, if already a registered Trading Partner).

Faxes, regular electronic mail and USB memory sticks will not be accepted.

We encourage applicants to submit applications via ePost Connect™ by completing the Enrolment Process to become a Trading Partner, which is a free service, provided that you are sending us correspondence in a conversation that was initiated by NNHPD. Licence applications, post-licence submission, and renewals are to be sent via the New NHP Applications Conversation, which we initiate with you once you enrol as a Trading Partner.

Natural and Non-prescription Health Products Directorate
Attn: Submission Administration Unit
250 Lanark Avenue AL 2002B
Ottawa, Ontario
K1A 0K9 (Canada Post delivery including Xpress Post)
K1Z 1G4 (Courier service excluding Xpress Post)

Public Involvement and Consultation

• For information about public involvement and consultation, contact the Office of Consumer and Public Involvement.

Regulatory Requirements for Advertising

• For information about regulatory requirements for Advertising contact the Regulatory Advertising Section of the Marketed Health Products Directorate.

Special Access to Drugs & Health Products

• For information about special access to drugs contact the Special Access Programme (SAP) - Drugs.
• For information about special access to medical devices contact the Special Access Programme (SAP) - Medical Devices.
• For information about donor semen special access contact the Donor Semen Special Access Programme.

Veterinary Drugs

• For general inquiries about veterinary products, contact the Veterinary Drugs Directorate.
• For information about filing submissions and cost recovery, contact the Veterinary Drugs Directorate's Submission and Knowledge Management Division.
• For questions about the classification of veterinary products, contact the Veterinary Drug Directorate.
• To request an Emergency Drug Release, follow these instructions.