Classes of Applications

There are three classes of applications, which are differentiated by their use of NNHPD monographs.

Class I

Class I applications are those that must comply with all of the parameters of one individual NNHPD monograph (exactly as worded in the monograph). The processing time is about 3~4 months.

Class III

Class III applications are comprised of general, traditional and homeopathic applications requiring full assessment (not captured above in Class I or II) and include, but are not limited to, the following scenarios:

• Products with a novel preparation and/or dosage delivery system presenting unique safety and/or efficacy profiles;

• Applications referencing a Master File to support safety, efficacy and/or quality.

• Products with ingredient combination issues that may require safety assessment.

• Applications partially referencing monograph information but going beyond the parameters established in the relevant monograph(s). Homeopathic applications with specific claims.

NOTE: The processing time for class 3 applications varies from 7 months to 12 months.

Site Licence (GMP Certificate)

A site licence issued by the Natural and Non-prescription Health Products Directorate (NNHPD, a division of Health Canada) gives the licensee authorization to conduct the activities such as manufacturing, packaging, labeling and importing of natural health products.

Health Canada requires that all manufacturers, packagers, labellers, and importers of natural health products (NHP) be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements.

Who needs site licence?

A site licence is required for the physical site in Canada where any persons (business or individual) wish to manufacture, package, label, and/or import a NHP for sale.

How to obtain the site licence?

A Site Licence Application (SLA) requires the applicant to submit evidence of GMP compliance such as GMP certificate, Drug Establishment Licence, or a Quality Assurance Report (QAR) outlining their GMP program, along with examples of certain written Standard Operating Procedures (SOPs) and any associated forms or checklists to demonstrate the compliance to tGMP requirements.

The site licence application must be completed by a qualified QAP who meets the NNHPD’s minimum qualifications in education, training & experience, in order to protect the quality of the finished product.

The Site License Application can be broken down into 4 various parts with each being contingent on the others.

1. Establishing a written Good Manufacturing Practices (GMP) Manual for your company and completing all manufacturing processes and procedures as outlined within. Establishing a Required Record Keeping System and completing all required documentation regularly.

2. Establishing a written Standard Operating Procedures (SOP) Manual for your company and completing all standard business operations, processes and procedures as outlined within. Establishing a Required Record Keeping System and completing all required documentation regularly.

3. Completing a Quality Assurance Report (QAR), or one of two following options to provide GMP evidence:

   1. • GMP Audit by a certified auditor at the cost of the company.

      • Complete a detailed Quality Assurance Report (QAR) identifying your GMP and SOP specifics. Provide this QAR to Health Canada as part of your Site License Application.

4. Complete your Site License Application Form, compile your Site License submission package and forward to Health Canada via ePost Connect.