Friday, December 09, 2011

Customs and Health Canada

I had my first refusal on the 27th of October. Regardless of the time stamps of the advisories, they have been amended from the original advisories - they filled in the loop holes.

This email is in response to your inquiry regarding electronic smoking products. On March 27, 2009, Health Canada posted a Public Advisory and a Notice to Stakeholders about electronic smoking products which are available at the following URL addresses:

Public Advisory: Health Canada Advises Canadians Not to Use Electronic Cigarettes - Health Canada Advisory 2009-03-27
Notice to Stakeholders: To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada - Health Canada Notice 2009-03-27
Notice to All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada:To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada - Health Canada Notice 2009-03-27

As per this advisory/notice, electronic cigarettes fall within the scope of the Food and Drugs Act and Regulations. As such, market authorization must be granted by Health Canada prior the importation and sale of these products in Canada. Currently, no electronic smoking products have been granted market authorization in Canada.

The Therapeutic Products Directorate (TPD) of Health Canada is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must submit substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations. .This is done through the filing of a drug submission to the TPD.
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Here is some additional information to clarify the classification of electronic cigarettes under the Food and Drugs Act:
  • a non-refillable disposable electronic smoking product (e.g., e-cigarette) prefilled with nicotine (or any other drug or Natural Health Product [NHP]) is considered to be a drug (or NHP)/medical device combination product and requires a DIN (or NPN). In this case, its drug delivery system is to be reviewed for safety and efficacy but a medical device license is not required;
  • a refillable electronic smoking product (e.g., e-cigarette) with nicotine or intended to be used with nicotine (or any other drug or NHP) is considered to be a drug (or NHP) delivery system and, therefore, a Class II medical device, and its nicotine (or drug or NHP) component requires a DIN (or NPN). (Please note that no medical device licence is to be issued until the associated drug component has received a DIN [or NPN].);
  • an electronic smoking product (e.g., e-cigarette) associated with a health claim but not associated with nor intended to be used with nicotine (nor any other drug nor NHP) is considered to be a Class I medical device.
General information
For information on drug submission filing in Canada, please see the links below:

Drugs and Health Products: Drug Products website

Drug Products - Health Canada


Regulatory Process in Canada.

Access to Therapeutic Products: The Regulatory Process in Canada [Health Canada, 2006]


Drug Identification Number (DIN)

Drug Identification Number (DIN)


For applicants

Health Canada classifies the nicotine component of an electronic cigarette product as a "New Drug" under the Food and Drug Regulations (Listing of Drugs Currently Regulated as New Drugs - Health Canada), and its delivery system component as a "Medical Device" under the Medical Devices Regulations.

New Drugs are regulated under Part C, Division 8 of the Food and Drug Regulations (
Food and Drug Regulations), and require the filing of a New Drug Submission (NDS). .Information on this process and requirements are provided via the links below. .New Drug Submissions must be supported by data obtained from non-clinical and clinical trials, conducted in accordance with international standards, or scientific rationales, to support the quality, safety, and efficacy of the New Drug.

The data requirement may vary according to the inhaled product and associated health claims (e.g. smoking cessation, temporary abstinence). Pharmacokinetic data, addictive properties, long-term safety (local and systemic), bystander exposure and the possibility of overdosage are examples of important issues/ information that would need to be addressed in the NDS. .The fact that non-smoker could use this product and develop addiction is another issue that would need to be addressed in the submission.


As well, the nicotine delivery system component of the electronic smoking product is considered to be a Class II medical device. .In order to sell this device in Canada, the manufacturer must first obtain an ISO 13485:2003 CMDCAS certificate from one of Health Canada's recognized registrars. .Once this certification has been obtained, the manufacturer must submit a Class II medical device licence application to the Medical Devices Bureau.


Guidance Documents and Application Forms

Submission Fee Application Form
Drug Submission/Application Fee Form - Drug Products


Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation
HC-SC 3011
Drug Submission Application for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation - Health Canada Form 3011


Clinical Trials

Clinical Trials - Guidance Documents - Drugs and Health Products - Health Canada


Drug Submission

Management of Drug Submissions Guidance
Guidance for Industry: Management of Drug Submissions


Submission Evaluation Fees Guide

Guidance Document: Fees for the Review of Drug Submissions and Applications [Health Canada, 2011]


Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)


Preparation of New Drug Submissions in the CTD Format

Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format


Guidance for Industry: Product Monograph

Guidance for Industry: Product Monograph [Health Canada, 2003]


Establishment Licences and the Good Manufacturing Practices guideline (GMP) can be accessed on the Health Products and Food Branch Inspectorate website

Establishment Licences - Compliance and Enforcement - Drugs and Health Products - Health Canada

Good Manufacturing Practices - Compliance and Enforcement - Drugs and Health Products - Health Canada


Medical Devices

Cost Recovery for Medical Devices: Establishment Licence and Licence Fee
Fees - Medical Devices


Class II licence application form

New Class II Medical Device Licence Application Form - Health Canada


Contacts

If you have any complaint related to electronic cigarettes or with regards to the importation of these products, please contact the Health Products and Food Branch Inspectorate (HPFB-I) Operational Centre in your region by calling 1-800-267-9675 or by the following website: Health Canada - This page has moved


If you have any questions with regards to the regulatory requirements in filing, please contact the Bureau of Cardiology, Allergy and Neurological Sciences (BCANS):

E-mail: bcans_enquiries@hc-sc.gc.ca

Telephone: (613) 941-1499
Fax: (613) 941-1668

If you need additional assistance in filing a new drug submission, please contact:
SIPDMAIL@hc-sc.gc.ca.

For further information on medical devices licensing, please contact the Medical Devices Bureau by telephone at 613-957-7285 or by email at
mdb_enquiries@hc-sc.gc.ca.

Kind regards,


Agente de la conformité/Compliance Officer

Unité de Vérification de Conformité et Enquêtes sur les drogues /
Drug Compliance Verification and Investigation Unit
Santé Canada, Région du Québec / Health Canada, Quebec Region
1001, rue St-Laurent O. / St-Laurent Street W.
Longueuil (Québec) .J4K 1C7
Tél / Tel. : 450-928-4011
Téléc. / Fax : 450-928-4455

Originally the agent was pleasant and very cooperative and stated the liquid could be removed from the package (since I didn't order liquid) and the package sent to me (26 Oct). Contacted Customs and they said they would verify with HC and get back to me.

Long and short the package has to be RTS.

I contacted aforementioned HC agent, who appeared knowledgeable and confident the previous day, to someone who had just been chastised by Mother Superior. Where once she was confident, poised and cooperative, she was now hesitant and back peddling.

When we hit the first 3 links, although they are old advisories Mar 2009, the data contained is indeed reworded to include but not limited to POL-001 which never appeared in the directives in the past. Package country of origin USA.

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