Here is an e-mail that I have aquired. This was in responce to a request of the documents required to get market authorization by Health Canada. Now, I understand that most of the members are from the U.S.A., but this has significance because Canada and US laws are very similar, meaning authorization in one country is authorization in both. But be warned, this gauntlet makes it nearly impossible for the small business owner, leaving the doors wide open for higher powers at be. I think as long as their legal in China, it's only a matter of time before our free world countries have to admit, can't beat em, join em. As long as e-smokers keep fighting, passing on the word, telling other smokers of the technology, and voicing our success stories, we should all be around for quite some time. Enjoy the read!! 
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:
Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada
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, advertisement and sale
of these products in Canada. Currently, no electronic smoking products have
been granted market authorization in Canada.
The text below contains HC's position on the regulatory classification of
electronic smoking products, including the no-nicotine scenarios.
To be advertised or sold in Canada:
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; and
an electronic smoking product (e.g., e-cigarette) not associated with
any health claim and not associated with nor intended to be used with
nicotine (nor any other drug nor NHP) is not regulated under the Food
and Drugs Act.
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.
General information
For information on drug submission filing in Canada, please see the links
below:
Drugs and Health Products: Drug Products website
Drug Products - Main Page
Regulatory Process in Canada
Access to Therapeutic Products: The Regulatory Process in Canada
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 (
New Drug List)
, 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
Submission Fee Application Form - Drug Products
Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical
Trial Applications/Attestation HC-SC 3011
Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation
Clinical Trials
Clinical Trials - Guidance Documents - Applications and Submissions - Drugs and Health Products
Drug Submission
Management of Drug Submissions Guidance
Guidance for Industry: Management of Drug Submissions
Submission Evaluation Fees Guide
Submission Evaluation Fees Guide
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
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
Good Manufacturing Practices - Compliance and Enforcement - Drugs and Health Products
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
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:
Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada
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, advertisement and sale
of these products in Canada. Currently, no electronic smoking products have
been granted market authorization in Canada.
The text below contains HC's position on the regulatory classification of
electronic smoking products, including the no-nicotine scenarios.
To be advertised or sold in Canada:
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; and
an electronic smoking product (e.g., e-cigarette) not associated with
any health claim and not associated with nor intended to be used with
nicotine (nor any other drug nor NHP) is not regulated under the Food
and Drugs Act.
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.
General information
For information on drug submission filing in Canada, please see the links
below:
Drugs and Health Products: Drug Products website
Drug Products - Main Page
Regulatory Process in Canada
Access to Therapeutic Products: The Regulatory Process in Canada
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 (
New Drug List)
, 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
Submission Fee Application Form - Drug Products
Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical
Trial Applications/Attestation HC-SC 3011
Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation
Clinical Trials
Clinical Trials - Guidance Documents - Applications and Submissions - Drugs and Health Products
Drug Submission
Management of Drug Submissions Guidance
Guidance for Industry: Management of Drug Submissions
Submission Evaluation Fees Guide
Submission Evaluation Fees Guide
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
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
Good Manufacturing Practices - Compliance and Enforcement - Drugs and Health Products
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
