Fax-Back Form for Exemption

To:
Submission Management Division
Natural Health Products Directorate (NHPD)
Basement, Qualicum Tower A, AL 3300C
2936 Baseline Road
Ottawa, ON K1A 0K9
Couriers: K2H 1B3
Fax 613-941-7308

Re: Consent and Statement – Conditions for Eligibility under the Natural Health Products (Unprocessed Product Licence Applications) Regulations

Please complete one form for each product that you wish to have exempted as per the Natural Health Products (Unprocessed Product Licence Applications) Regulations.

• This form allows you to pre-emptively opt-in to the exemption.
• If a product is pre-emptively opted-in before it becomes eligible to receive an exemption, and the product licence application does remain at NHPD for 180 calendar days without a regulatory decision made (license, refusal or withdrawal), the exemption number would become valid in Health Canada’s NHP Exempted Products Database automatically on day 180.
• Companies should verify that the information regarding their exempted product in the Database is present and correct.
• Once completed, please submit pages 1-3 of this form to the NHPD with your product licence application to pre-emptively opt-in.
• Alternatively you may send this form to the address or fax number provided above within 60 days of the date the product is eligible for an exemption, as indicated in the Application Acceptance Letter that you may receive for this product. Companies should allow 5 working days after submitting this form for NHPD to update the NHP Exempted Products Database.
• Your exemption number will be the prefix "EN" followed by the submission number that was assigned to your product.
• Please note that the signature of the Senior Official (or Designated Third Party) must be provided for eligibility under the NHP (Unprocessed Product Licence Applications) Regulations.
• Forms that are incomplete will not be processed.
• If you have any questions on how to complete this form or regarding the information appearing in the NHP Exempted Products Database, please contact a Submission Coordinator or email pla.info.dlmm@hc-sc.gc.ca.

Attestation

As certain products are not eligible for exemption under the Natural Health Products (Unprocessed Product Licence Applications) Regulations, by signing this form I am attesting that:

1. The product for which I would like the exemption to apply is not:
   
   
   1. a sterile product for ophthalmic use;
   2. a drug referred to in any of sections C.01.036, C.01.036.1, C.01.040 or C.01.040.1 of the Food and Drug Regulations or a drug that is adulterated within the meaning of section C.01.038 of those Regulations (see Appendix C),
   3. a product that is recommended for use as a treatment, preventative or cure in respect of a disease, disorder or abnormal physical state referred to in Schedule A to the Food and Drugs Act; (see Appendix B) or
   4. a product that is recommended for use in children under 12 years old; or
   5. a product that is recommended for use in pregnant or breastfeeding women; or
   6. to the best of my knowledge a product that contains an ingredient that is likely to result in injury to the health of a purchaser or consumer and whose presence in a natural health product or other drug has led to:
      
      
      1. a recall of that product or other drug (see Appendix A), or
      2. the sale of that product or other drug being stopped under section 17 of the Natural Health Products Regulations or section C.01.013 of the Food and Drug Regulations, respectively.
         
         
2. A valid site licence will exist for the manufacturing, packaging, labelling and/or importing for this natural health product for which I am requesting an exemption when it commences sale.

Please note: Section 5 of the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) requires that “a person who is deemed to have been issued a product licence for a natural health product must provide the Minister with the information referred to in subsection 22(1) of the Natural Health Products Regulations before commencing the sale of the product under the deemed product licence”.  Please note this includes the Site Licence (SL) Number.

Consent

In addition, by signing this form I acknowledge and consent to Health Canada posting on its website the following information for the product licence application pertaining to the above-mentioned company, for which I would like the exemption to apply:

1. the Applicant’s name (i.e., Company Name);
2. the Exemption Number;
3. the Brand Name (including dosage form); and
4. the Exemption Status (i.e., Valid, Not Valid or Licence Issued)

Signature of authorized Senior Official or Designated Third Party
(If signed by Designated Third Party, records showing authorization of Designated Third Party must be on file at NHPD or attached)

Date

Attachments:

Appendix A - List of ingredients whose presence in a natural health product or other drug has led to a recall, or the sale of that product or other drug (being stopped under section 17 of the Natural Health Products Regulations or section C.01.013 of the Food and Drug Regulations, respectively)

Appendix B - Schedule A. Section 3 of the Food and Drugs Act states “No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.” ( http://laws.justice.gc.ca/en/showdoc/cs/F-27/sc:1//en#anchorsc:1) It also states “No person shall sell any food, drug, cosmetic or device

1. that is represented by label, or
2. that the person advertises to the general public

as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.”

Appendix C – Link to Sections C.01.036, C.01.036.1, C.01.040 or C.01.040.1 of the Food and Drug Regulations ( http://laws.justice.gc.ca/eng/C.R.C.-c.870/page-2.html#codese:C_01_036)

Appendix A

An ingredient whose presence in a natural health product or other drug has led to a recall of that product or other drug, or the sale of that product or other drug being stopped under section 17 of the Natural Health Products Regulations or section C.01.013 of the Food and Drug Regulations, respectively.

Proper Name	Common Names	Source Material	Exceptions	Rationale
Aphanizomenon flos-aquae	Aphanizomenon flos-aquae, Blue green algae	Whole cell	None	High probability that products containing Aphanizomenon flos-aquae could be contaminated with the hepatotoxins microcystin-LR and -LA. There are known severe side effects (including hepatotoxicity and death) associated with the ingestion of microcystins.
Collodial Silver	Collodial Silver		Collodial Silver is acceptable in homeopathic medicines at potencies of 3X or higher. Topical colloidal silver is acceptable.	Evidence indicates that risks to health likely outweigh possible benefits. The amount of silver provided by an oral daily dose of silver may exceed the Tolerable Daily Intake (or oral reference dose) for silver from all sources for any subpopulation.
D-Amygdalin Laetrile	D-Amygdalin Laetrile	Prunus armeniaca (Seed)	None	Likelihood of serious adverse health consequences from cyanide released by ingestion of amygdalin.
Ephedra sinica Stapf (Ephedraceae)	Cao ma-huang Chinese ephedra Chinese joint-fir Ephedra Ma-huang	Whole plant Branchlet and/or branch, stem	Ephedrine hydrocholoride is acceptable in homeopathic medicines at potencies of 12 CH or higher.	Adverse effects associated with ephedra/ephedrine can include dizziness, headache, decreased appetite, anxiety, restlessness or nervousness, gastrointestinal distress, irregular or fast heartbeat, insomnia, flushing, sweating, hypertension, stroke, seizures, psychosis and death.
l-Ephedrine	l-Ephedrine	l-Ephedrine l-Ephedrine hydrochloride l-Ephedrine sulfate
Larrea tridentate Larrea divaricata	Chaparral Creosote-bush Paloondo	Leaf	Larrea divaricata is acceptable in homeopathic medicines at potencies of 1X or higher. Topical chaparral is acceptable.	Potential for liver and kidney problems.
Lumbrokinase	Earthworm fibrinolytic enzymes (EFE)		None	Fibrinolytic enzymes should only be used under the supervision of a health care practitioner. They may interact with other prescription or non-prescription fibrinolytic or blood-thinning drugs.
Nattokinase	Nattokinase
Piper methysticum	Kava Kava-kava Kava pepper Kawa pepper Yanggona	Piper methysticum (Whole plant)	Piper methysticum is acceptable in homeopathic medicines at potencies of 1X or higher.	Adverse events including liver toxicity can occur when kava is administered.
Synephrine AND Caffeine	Synephrine AND Caffeine	Citrus aurantium (Fruit peel) AND Camellia sinensis (Leaf) Coffea arabica (Seed) Cola acuminata (Seed) Ilex paraguariensis (Leaf) Paullinia cupana (Seed)	None	Potential for cardiovascular toxicity.

Appendix B

Schedule A
(Section 3 of the Food and Drug Act)

 http://laws.justice.gc.ca/en/showdoc/cs/F-27/sc:1//en#anchorsc:1

Appendix C

Sections C.01.036, C.01.036.1, C.01.040 or C.01.040.1
of the Food and Drug Regulations

 http://laws.justice.gc.ca/eng/C.R.C.-c.870/page-2.html#codese:C_01_036