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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

Contact the

Health Product Compliance Directorate

(HPCD) for information about Health Canada's national compliance and enforcement program. Contact the HPCD for all drugs and health products for human and veterinary use regulated under its mandate, including:

Director General's Office

Drug establishment licensing

Drug shortages and discontinuations

Good Manufacturing Practices (GMP) inspection program

Good Pharmacovigilance Practices (GVP) inspection program

Health Product Border Compliance Program

Health Product Compliance and Enforcement (compliance verification)

Mutual Recognition Agreements and International Affairs

To submit a complaint regarding an alleged violation of the Food and Drugs Act and related Regulations with regard to health products please complete the

Health Product Complaint Form (FRM-0317)

.

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

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

.

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