Training

Although there are several guides and informational pages on Health Canada’s website, it can still be difficult to navigate. PSN/NHP SOLUTIONS offers à la carte and customized training courses covering all regulatory aspects of natural health products in Canada, from development to sale. We offer on demand training as well.

Class I and II product license application

Did you know that the rejection rates for Class I and Class II applications are 12% and 43%, respectively? Applications for Class I and Class II products are based entirely on one or more monographs from the Natural and Nonprescription Health Products Directorate (NNHPD). Although these are the least complicated applications, they are subject to certain constraints that can significantly delay the issuance of a product licence. This training will teach you how to complete a licence application, what other documents must be included with the application, and what mistakes to avoid to ensure you successfully obtain a product licence.

Apply for a class III product license

Applications for Class III product licenses require significantly more information and time than those for Classes I and II. These applications may partially refer to information in a monograph or include an ingredient not listed in a monograph. In addition to the application form and the finished product specifications, other documents must be submitted to demonstrate the product’s safety, efficacy, and quality. This training will teach you how to submit a complete and well-supported application to Health Canada to maximize your chances of success.

Amendment application of a product license

There are several reasons to submit an application to amend a license, whether it involves a new name, a change in non-medicinal ingredients, a new source for the medicinal ingredient, a new dosage, a new risk, or any other information contained in the license. This training will help you identify changes that are not permitted, as well as familiarize you with all the steps and documents required to submit an amendment application without any surprises.

Contact with Health Canada

Communication with Health Canada takes place electronically, either by email, via LiquidFiles or via ePost. The reason for contacting Health Canada determines which method is used. There are many reasons to contact Health Canada, such as to apply for a marketing authorization, update information contained in a license, report an error in a monograph, request a review of a decision, change the status or condition of a license, and many others. This training will enable you to communicate effectively with Health Canada using the appropriate tools.

Natural health product label

There is a lot of information that must appear on the label of a natural health product (NHP), despite the limited space available. It can be difficult to determine what is required and what is optional. A product information table (PIT) must be included on the label. This training will enable you to create a label that meets all the requirements of current regulations.

Natural health product quality

Natural health products (NHPs) must meet three requirements: safety, efficacy, and quality. The product licence holder is responsible for ensuring the quality of any NHP for which they have obtained a product license and for establishing its specifications. There are requirements regarding both ingredients and the finished product. This training will help you select the right ingredients and bring a product to market that meets all applicable regulatory requirements.

Advertising a natural health product

According to Section 9(1) of the Food and Drugs Act, it is prohibited to label, package, process, prepare, or sell a drug—or to advertise it—in a manner that is false, misleading, or deceptive, or that is likely to create a false impression regarding its nature, value, quantity, composition, benefits, or safety. The line between what is permitted and what is not is sometimes very fine. This training will help you understand the nuances and determine the limits of the claims that may be included in an advertisement.

Challenging of a notice of refusal of a product license

If you receive a refusal for a product license and believe the reasons given are not justified, you can request a reconsideration of the refusal decision to Health Canada. This training will help you determine whether an appeal is worthwhile and understand all the steps involved in the appeal process.

Formulating a natural health product

You have a product idea but aren't quite sure where to start. Whether you're starting with a specific ingredient or a desired health claim, this training will help you create customized formulations for specific claims while ensuring that safety, efficacy, and quality are verified.

Natural health products ingredients database

The starting point for developing and registering natural health products (NHPs) is the Natural Health Product Ingredient Database (NHPID) and the Monographs. These two tools allow you to identify ingredients authorized for use in NHPs and all related information. This training will teach you how to navigate these resources and find the information you need.