Compendial Product Licence Applications: Completeness Checklist

March 2008 - Version 3.0

The following checklist is a resource tool to be used by applicants intending to submit a compendial product licence application (PLA) for a natural health product. This list is also used internally by Health Canada during the review of compendial applications.

Compendial product licence applications are those where the applicant is referencing an official NHPD monograph published in the Compendium of Monographs. In accordance with section 6 of the Natural Health Products Regulations, compendial product licence applications are processed within 60-days of receipt.

Applicants are encouraged to carefully review their product licence applications prior to submission to ensure that all necessary information has been provided. This checklist can be used during the revision process to help applicants ensure that their compendial PLAs have been properly filled out.

Key Point When Preparing a Compendial Product Licence Application

The information provided in the application (e.g. source information, proper name, common name, etc.) must match the information found in the referenced monograph. Deviations of any kind from the referenced monograph are not acceptable for compendial product licence applications and will result in refusal.

Additional resources for compendial product licence applicants:

• Product Licensing guidance document
• Labelling guidance document
• Compendium of Monographs

Compendial Completeness Checklist (11 Items in total)

Product Licence Applcation Form Requirements:

Item 1

1. There exists a NHPD monograph (published in the Compendium of Monographs) for the medicinal ingredient or product indicated on the product licence application form (PLA).

If the Compendium of Monographs does not include a monograph for your medicinal ingredient or product, you cannot submit a compendial product licence application for your product.

NOTE: Natural health products that contain multiple medicinal ingredients that are monographed individually are not considered compendial products and applicants cannot submit a compendial product licence application (since a combination rationale is required).

• Yes
• No

Item 2

2. The brand name(s) indicated on the PLA does not/do not contravene Section 9 of the Food and Drugs Act.

Section 9(1) of the Food and Drugs Act states that "No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety."

• Yes
• No

Item 3

3. The medicinal ingredient(s) on the PLA is/are acceptable as per the referenced monograph.

• Yes
• No

Item 4

4. The non-medicinal ingredient(s) on the PLA is/are acceptable as per the referenced monograph.

• Yes
• No

Item 5

5. The recommended dose on the PLA is acceptable as per the referenced monograph.

• Yes
• No

Item 6

6. The recommended conditions of use on the PLA are acceptable as per the referenced monograph.

"Recommended conditions of use" includes the following:

• Use(s) or Purpose(s)
• Dosage form
• Route of administration
• Duration of use
• Risk information

• Yes
• No

Labelling Requirements:

Item 7

7. The label text is acceptable as per Section 93, Section 94 (if applicable) and Section 95 of the Natural Health Products Regulations.

Applicants may refer to the Labelling guidance document for further information on the labelling requirements for NHPs. Specifically:

• Chapter 3.1 and 3.2 for inner and outer label requirements (section 93 of the Regulations)
• Chapter 3.3 for small packaging labelling requirements (section 94 of the Regulations)
• Chapter 3.4 for security labelling requirements (section 95 of the Regulations)

• Yes
• No

Item 8

8. The information on the label text is identical to the Product Licence Application form.

• Yes
• No

Item 9

9. The advertising on the label does not contravene Section 9 of the Food and Drugs Act.

Section 9(1) of the Food and Drugs Act states that "No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

• Yes
• No

Animal Tissue Form Requirements (if necessary):

Item 10

10. A complete Animal Tissue form has been provided for all ingredients sourced from animal material(s).

• Yes
• No

Item 11

11a. There are BSE/TSE risks associated with the Animal Tissue form(s) provided.

• Yes
• No

11b. If the answer to item 11a is "yes", additional information demonstrating how the risks of BSE/TSE are mitigated has been provided with the application*.

Further guidance is available in the Revised Policy Regarding Gelatin in Natural Health Products

• No

Answering "No" to any of the 11 items listed above (with the exception of item 11a) means that the compendial application is incomplete and will be refused by the Natural Health Products Directorate (NHPD). If you answer "Yes" to Item 11a, you must answer "Yes" to Item 11b and provide additional information demonstrating how the risks of BSE/TSE are mitigated. Answering "No" to Item 11b will result in the refusal of the application.