Instructions for Completing the Summary of Net Changes Form

Please read the instructions prior to completing this application.

Parts 1 through 6 must be completed for each Canadian and/or foreign site.

Part 1: Site Information

Name of Company: The legal name of the applicant or company as it appears on the site licence.

Part 2: Attestation

To be completed by the company’s Quality Assurance Person.

Part 3: List of Observations and Corrective Actions with Date of Completion (if applicable)

Please refer to your last site licence cover letter or foreign site reference number (FSRN) Notice of Acceptance for the list of observations noted by the Natural and Non-prescription Health Products Directorate (NNHPD), if applicable. The applicant must address any observations noted by the NNHPD and describe the corrective action(s) taken.

Part 4: Summary of Net Changes (SNC) and Description

The applicant must identify changes which have occurred since the last site licence/FSRN issuance or renewal by checking the appropriate box(es). In addition, please provide a detailed description of the change(s) by completing the corresponding questions of the Quality Assurance Report (QAR) form and/or the Supplementary Quality Assurance Report (SQAR) form, if applicable, and attach to this form. Alternatively, provide another form of acceptable good manufacturing practices (GMP) evidence to support the changes mentioned. Note: Even if no changes have occurred within the last 12 months, records (as per part 5 below) from within the last 12 months are still required.

For example: Changes to equipment would be described in the response to question 4 of the QAR and corresponding page(s) would be attached to the Summary of Net Changes form.

Part 5: Records Section

Samples of specific completed records from within the last 12 months for each site, are required along with the SNC form. Though the NNHPD may request additional records based on the totality of information provided and the assessment conducted, one sample record is required for each section per site. All documents must be provided in one of Canada's official languages. Alternatively, a translated version maybe provided along with the original document.

Contracting: In cases where a contractual arrangement exists for the manufacturing, packaging, labelling, importing, and/or storage of natural health products, the above requirements with respect to records remain applicable. In addition, the applicant must provide a copy of the quality technical agreement in question (signed and dated by the parties involved), indicating the name and address of each party, and the activities that each are conducting, in accordance with Part 3 of the Natural Health Products Regulations (NHPR). The licensed status of each party involved in the agreement (whether they hold a site or establishment licence) should be indicated as well.

Part 6: List of Products Manufactured, Packaged, Labelled, Imported and/or Stored at the Site

Applicants must fill out the table by providing the information requested. The table should list all products (intended for the Canadian market) manufactured, packaged, labelled, imported and/or stored for the last 12 months.