PRODUCT LICENSING INFORMATION Modifications to product by ngl20621

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									The NHPD Monthly Communiqué is a publication of Health Canada’s Natural Health Products Directorate
(NHPD), the federal department responsible for the regulation of natural health products sold in Canada. The
communiqué is released to the Canadian public the first Monday of each month via the NHPD’s electronic
bulletin. Subscription to this e-bulletin is available at www.hc-sc.gc.ca/dhp-
mps/prodnatur/activit/education/list/index_e.html.

Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to
NHPD_DPSN@hc-sc.gc.ca.

Each NHPD Monthly Communiqué is separated into four sections for ease of reference. These are: Product
Licensing Information, Site Licensing Information, Clinical Trial Information and Other Information.


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PRODUCT LICENSING INFORMATION:
Modifications to product licensing requirements:
   1. Contact information on product label: The NHPD has determined that the following is acceptable
      minimum contact information for labels of natural health products:

           •   For domestic NPN holders: Name of the NPN holder and postal code
           •   For foreign NPN holders: Name of the NPN holder and postal code AND the name and postal
               code of the Canadian importer.

Common errors and deficiencies
The following is a list of common errors and deficiencies found in product licence applications sent to the
NHPD. These errors, though they may seem minor in some cases, can lead to major time delays and can be
easily avoided if applicants take the time to properly prepare and review their applications before submitting
them to the NHPD.

   1. No evidence submitted: The product licence application does not contain any safety and efficacy
      evidence to support the use of the product at the recommended dose indicated. This is a crucial part of
      the application as it is this information that the NHPD will use to determine if the product is safe and
      effective for sale in Canada. Applicants that do not cite any evidence in their submissions will be sent
      an Acknowledgement Notice outlining the deficiency and if the information is not provided within 30
      days, the submission will be withdrawn.


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2. Missing signature on product licence application (PLA) form: The attestation on page 6 of the PLA
   form has not been signed by the senior official or their designated party. Applicants must ensure that
   the person signing the PLA form is indicated to be a senior official on page 1 of the PLA form or submit
   a Designated Party Authorization form granting signing authority to this person. The Designated Party
   Authorization form can be found at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-
   prod/form/index_e.html.

3. Animal Tissue used in the processing but no Animal Tissue Form was provided: To date, in
   Part 4 of the PLA form, many applicants have answered “yes" to the question: "Was animal tissue
   used in the processing of this product?", but have not included an Animal Tissue Form with their
   submission. If an animal tissue is used in the product, applicants must include a completed Animal
   Tissue Form with their submission package. Alternatively, if no animal tissue was used in the
   processing of the product, indicate "no" as a response to the question in Part 4 of the PLA form. The
   Animal Tissue Form is available at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-
   prod/form/index_e.html.

4. Missing information for Traditional Claim application: This error occurs when an applicant
   indicates on the PLA Form that they are making a traditional claim application, but fails to provide the
   following information
        a. Information demonstrating that the method of preparation used is considered traditional.
        b. With respect to the use or purpose of the product, a traditional qualifier such as "traditionally
           used as..."
        c. Two independent traditional references to support the traditional health claim and an evidence
           summary report to support information that is not covered in the two traditional references.
           These traditional references must indicate that the product has been used safely and effectively
           for 50 consecutive years.

   Applicants wishing to make an application for a “traditional use” product must submit the information
   listed above in points A, B, and C. Otherwise, they should confirm that their product does NOT have a
   traditional use claim, thus rendering it a non-traditional product. Upon this confirmation, the product
   will be re-classified as a non-traditional product, and it is not required to submit the information
   mentioned in A,B, and C.

5. PLA form submitted in language other than French or English: Many applications for traditional
   Chinese medicines and Ayurvedic products are submitted to the NHPD in languages other than
   French or English, such as Mandarin, Chinese or Punjabi. Applicants must submit all their information
   in French or English. The NHPD will only accept and process applications written or typed
   (preferably) in one of the two official languages of Canada. In cases where the applicant does not
   have access to the information in French or English, he/she must have it translated before submitting.

6. Compendial application citing information NOT found in an official NHPD Monograph:
   Applicants making a “compendial” product licence submission must ensure that ALL the information
   provided reflects the information specified on the referenced NHPD monograph (e.g. the source
   material must be "exactly" the same as a source material indicated on the monograph. The same
   applies to the Medicinal Ingredients found in the product). Variations of any kind will result in the
   application being considered non-compendial and ineligible for our review within 60-days.




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   7. Inner and Outer Label: For the labeling section of your product licence application, please be sure to
      clearly indicate if the information submitted is for the outer or inner label. Further information on our
      inner and outer labeling requirements is available in Chapter 8.1 of our Product Licensing Guidance
      Document (www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/license-
      licence_guide_8_e.html#8_1).

Product classification issues:
Each product licence submission that is received at the NHPD is classified to ensure that all of the
ingredients found in the product meet the definition of a natural health product. According to the definition,
the product can only contain medicinal substances found on Schedule 1 of the Regulations, and must
exclude substances found on Schedule 2. In addition, natural health products cannot contain substances
listed on Schedule F of the Food and Drugs Act.

In many cases, the PLAs submitted to the NHPD are for products which contain Schedule II and other
prohibited substances such as drugs, cosmetics, biologics, and/or tobacco. Products containing Schedule II
and other prohibited substances cannot receive market authorization as natural health products. The following
is a list of the most common prohibited substance found in product licence applications received to date:

                   - Bovine/porcine adrenal extract (containing adrenocortical hormones)
                   - Vitamin A greater than 10,000 IU
                   - GotuKola extract
                   - Theobromine
                   - Zinc Pyrithione
                   - TEA Salicylate
                   - Yohimbine
                   - L-Tryptophan
                   - L-carnitine
                   - DMAE- dimethylaminoethanol also known as Deanol

Products containing any of these substances CANNOT be authorized for sale as natural health products.
Applications for products containing these substances will be removed from our review queue. Further
information on substances prohibited for inclusion in natural health products is available under Part A of the
Natural Health Products Compliance Guide (www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/compli-
conform/complian-conform_guide_parta_e.html).


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SITE LICENSING INFORMATION:

New Quality Assurance Report Form (QARF)

   1. New QARF Form: A new QARF form has been developed and is currently available on our Web site
      at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/index_e.html.
      Applicants must now use this new form at all times when applying for a site licence.

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Site Licence Renewal

In accordance with section 36 of the Natural Health Products Regulations, persons issued a site licence are
required to renew their licence every year for the first three years since its date of issuance. In order to
successfully renew your site licence, the following information must be submitted to the NHPD for review:
           a. Review the Renewal Summary Report, to ensure that the information therein corresponds with
               the present situation in your company and relevant buildings.
           b. Complete the Record of Change Template and update the Renewal Summary Report
               (partially completed site licence application form) with information regarding these changes
               and any other relevant information. If there have been no changes, indicate this in the Record
               of Change Template.
           c. Provide an updated Quality Assurance Report for each existing and new building, with
               samples of records that have been in use within the last six months or a valid Establishment
               Licence.
           d. Provide a new Quality Assurance Person qualification Form, if a different Quality Assurance
               Person has been assigned under the requirements set out in Section 51 of the Natural Health
               Products Regulations. Please include photocopies of Degrees/Diplomas.

Common errors and discrepancies

   1. Missing Information for the Quality Assurance Report Form (QARF): To date, the most
      commonly omitted information from the QARF has been Standard Operating Procedures (SOPs) and
      Records:

           •   Missing SOP Information:
                    i. Finished Product Testing SOP
                   ii. Release of the Finished Product SOP
                  iii. Product Recall SOP

           •   Missing Record Information:
                    i. Cleaning record (surfaces, equipment etc.)
                   ii. Environmental control/monitoring record
                  iii. Finished Product Release Record (with signature of Quality Assurance Person)
                  iv. Complaint Handling Record
                   v. Pest Control Record (ex: invoice from Professional company)
                  vi. Product Recall Record or Template (if a recall has never - occurred)

       These SOPs and records must be included in the QARF in order for us to proceed with the evaluation
       of your submission.

   2. Missing information for site licence renewal: To date, the most commonly omitted information from
      the site licence renewal packaged has been:
                    i. Quality Assurance Report Form with the required records showing compliance over the
                       previous year.
                   ii. Quality Assurance Person Qualification Form with any new experience, training and
                       education certifications included.
      This information must be included in the site licence renewal package in order for the renewal to be
      granted by the NHPD.
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CLINICAL TRIALS INFORMATION:

No new information to provide at this time. All clinical trial requirements can be found in the Clinical Trial for
Natural Health Products Guidance Document, which is available at www.hc-sc.gc.ca/dhp-
mps/prodnatur/applications/clini/docs/index_e.html.


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OTHER INFORMATION:
   1. Incorrect address locator in NHPD mailing address: The NHPD has discovered that the Address
      Locator (A.L) for the Submission Management Division (SMD) indicated in the majority of our guidance
      documents is incorrect. When sending your submission to the SMD, please be sure to indicate the
      following address locator: 3300B.

   2. New web link for the NHPD: Health Canada has recently launched its new integrated Web site. For
      quick access to the section pertaining to natural health products, please use:
      www.healthcanada.gc.ca/nhp.




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