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Product Licensing Forms and Templates
The Natural Health Products Regulations require individuals to obtain a product licence before they can sell a natural health product in Canada. To obtain a product licence, individuals must submit a product licence application to the Natural Health Products Directorate (NHPD). The application must include sufficient data to allow the NHPD to assess the safety, quality and efficacy of the natural health product when used under its recommended conditions of use.
To obtain more details on what constitutes a "complete" product licence application, consult the table titled "Information Requirements for Product Licensing".
Forms
Please use the PDF versions to fill the forms out and save it to your computer - the HTML format should only be used for viewing the forms. The Natural Health Products Directorate no longer accepts hand-written applications.
The Electronic Product License Application (ePLA) is the primary form which is intended for use with Non-Traditional, Homeopathic, Traditional and Compendial applications that cannot have their monographs generated (pre-populated) within the ePLA. Monographs that cannot be generated are listed in the Natural Health Products Ingredient Database (NHPID) as product monographs or single ingredient monographs that do not have an asterisk beside their name.
An alternate form titled the Compendial from Generated Monograph ePLA (CfGM ePLA), is intended for use with Compendial applications that can have their monographs generated within the ePLA. Generated monographs can be identified in the NHPID by the asterisk found beside the monograph's name.
- Designated Party Authorization Form
- Finished Product Specifications
- Product Licence Application Form
- Finished Product Specifications Form
Important Notice
The Natural Health Product Directorate strongly encourages applicants to submit applications and replies to deficiency/information requests by courrier service (when the response is too large to fax) because of its greater reliability. Please note that we do not accept the submission of applications by fax or non-PosteCS email.
Please send your submissions by courrier service to the Submission Management Division:
Natural Health Products Directorate
Submission Management Division
Qualicum Tower A
2936 Baseline Rd.
Ottawa, Ontario
K2H 1B3
Fax: (613) 954-2877
Questions regarding submissions should be emailed to: pla.info.dlmm@hc-sc.gc.ca
Other Forms
Please note that it is the intent of NHPD that the ePLA will be the only form accepted in the future. NHPD cannot commit to the performance targets outlined in the Management of Product Licence Applications for Natural Health Products Guidance Document for applications received in any other format and applicants should expect a substantial increase in processing time. Applicants should only consider the form below when applying for a Labelling Standard licence not compatible with the ePLA (e.g. organotherapy labelling standards) or for a product containing a proprietary ingredient.
