Customs and Health Canada

[Switched]

There has been a change in venue as of this afternoon (27 Oct 09)

<<Hi,

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.
.
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 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.

All folks need to know is that the package came from the States.

 

[Resawman]

Ok got me wondering

 

[Switched]

So based on my conversations of yesterday afternoon, one needs market authorization to import ecig products. When an individual orders across the border, it is considered import and hence unauthorized, without prior approval from HC (market authorization)

 

[mopar]

Well that certainly doesn't bode well for us

 

[Switched]

No it doesn't. I was quite pleased with the original outcome, but not the latest.

 

[NoizMaker]

Ouch... Obtaining the Market Authorization to sell or import e-cigs/ nic would be a very costly and arduous process. I'm kind of speechless...

 

[nuclearbroccoli]

Would someone please explain to me how HC deems nicotine in an electronic cigarette to be a ”new drug”, and how the hardware is considered a” medical device”?
Nicotine is not a new drug, and an electronic cigarette is not necessarily a medical device, at least to me. By that logic, shouldn't an analog be regulated the same way?

 

[Switched]

You need to read the links with open eyes and dispassionately. Nicotine was always a schedule F drug way before ecigs came about. All HC has done in the links (old) were close the loop holes under POL-001 which would not surprise me if it came about from Bill C-36.

 

[DWEL]

isn't that article dated from 2009?

 

[Switched]

isn't that article dated from 2009?

... and the point?

They are using an updated directive. Read the words carefully. If you are new with the article I can see your apprehension. There has been a cut and paste job. When dealing with these folks you use caution (protect the community). As stated if you read from the beginning packkage was going to be sent on its way sans liquid. The next day everyone was back peddling, etc... I must of misunderstood. I didn't mis-understand?

 

[mopar]

HC can do what ever they want as long as their directive suits the majority government in power. They can piggy back anything onto a popular bill in the fine print and pass it. I didn't even get a response from my MP regarding bill c-32.

 

[Switched]

HC can do what ever they want as long as their directive suits the majority government in power. They can piggy back anything onto a popular bill in the fine print and pass it. I didn't even get a response from my MP regarding bill c-32.

Yup! Just like Bill C-68 (our version of the Patriot Act) cannot be found in B&W so to speak, but tidbits of the entire Act piggy backed on existing legislation.

We have Ninja law makers in Canada LOL, come in under cover of darkness and leave before sunrise. BTT the sun comes up, the damage is done.

 

[SharonCC]

Let me see if I understand this....Now, we can't order juice OR hardware from the US. The Canadian vendors won't be able to get the same, so we're stopped?

 

[Switched]

Once upon a time liquid didn't make it through but hardware did. You got my PM which I thought was rather cool. The following day however, a totally different tune. I could not argue without putting the community in jeopardy. In 20 months and over 100 orders this is the first time I got hit. What POs me the most, I didn't order any juice

Wrt the rest you got my PM so you are safe.

 

[mopar]

Just RTS reship and order more. Seperate packages etc. There will be no stopping us until it is available at the corner store/pharmacy etc and then most people will just be to lazy to bother going on-line. I really hope the vendor's here are collectively trying to make it so they can stay in business.

 

[Switched]

2 vendors have full market authorization. Hint they don't sell nic.

 

[Concat]

Let me see if I understand this....Now, we can't order juice OR hardware from the US. The Canadian vendors won't be able to get the same, so we're stopped?

It's logistically impossible to ban the hardware. There's nothing fancy about it. Battery + heating element. I'd like to see them try and ban that. It's like banning bottles because people make moonshine. Not gonna happen.

 

[smokum]

It's all in the presentation and accompanied documentation........ to avoid market authorization, just call it ELECTRONICS or HOBBY KIT, etc

 

[Switched]

It's logistically impossible to ban the hardware. There's nothing fancy about it. Battery + heating element. I'd like to see them try and ban that. It's like banning bottles because people make moonshine. Not gonna happen.

They refused entry to my atomisers and cartomisers. So your observation is pretty moot. Read the links...

 

[Switched]

It's all in the presentation and accompanied documentation........ to avoid market authorization, just call it ELECTRONICS or HOBBY KIT, etc

Pretty hard to do that when they opened the package and knew what they were looking at? I just love Monday morning lawyers Still batting .900 after 20 months I say that is pretty darn good