Notice to Stakeholders Regarding Site Licensing Update

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December 1, 2015

To: All interested parties

I am pleased to inform you that Health Canada has revised and finalized the documents entitled Good Manufacturing Practices (GMP) guidance, Site Licensing (SL) guidance, and Quality Assurance Report (QAR) form, which are now available on the Health Canada website.

Draft versions of these documents were posted on the Health Canada website for a 90-day consultation from June to September 2014. All revisions and clarifications suggested by stakeholders were considered and incorporated, as appropriate, during the finalization of the documents. A summary of key changes is included below.

I would also like to take this opportunity to provide an update on the Revised Approach to natural health product (NHP) Site Licensing (RASL) proposal paper, posted for a 90-day consultation from January to April 2014, and the associated on-site audit pilot program.

Update on Revised Approach to NHP Site Licensing

The Revised Approach to NHP Site Licensing (RASL) document outlined a proposal to revise the Department's approach to site licensing of NHP establishments. The proposal included an on-site audit pilot program, a risk classification system for NHP GMP observations, criteria for third-party auditors, and updates to the current paper-based assessment process. The Natural and Non-Prescription Health Products Directorate (NNHPD) committed to conducting and communicating the results of a mini-pilot, launching a one-year pilot, and finalizing associated documents, which include the guidance documents and form mentioned above.

Feedback Received from the Mini-Pilot

A mini-pilot was conducted from April to May 2014. The feedback received from companies and auditors highlighted that there are areas for improvement in the proposal (e.g. audit criteria and the depth of the audit, auditor roles and responsibilities, and auditor training). The NNHPD also noted that further work is needed to ensure that the approach taken is aligned with that for other products of similar risk.

Moving Forward

Since the mini-pilot was conducted, Health Canada launched a public consultation from November 2014 to February 2015 on a Consumer Health Products Framework, which proposes a proportionate and aligned approach to the regulation of consumer health products (NHPs, non-prescription drugs, disinfectants, and cosmetics). The results of the mini-pilot and next steps will be considered within the broader context of the Framework.

Guidance Document Feedback and Summary of Key Changes

The NNHPD received feedback from various stakeholders, who generally supported the updates to the GMP guide, SL guide and QAR form. Feedback focused on clarifying operational details and processes, interpretation of GMP requirements, and evidence requirements in support of a site licence application. Some concerns were also raised regarding the feasibility of the proposed 45-day service standard for site licensing. The need for predictability and consistency was emphasized by stakeholders over shorter review timelines. All revisions and clarifications suggested by stakeholders were taken into consideration and incorporated, as appropriate, during the finalization of the documents. The key changes made to each document, as a result of the consultation, are summarized below. Details regarding three specific changes are also outlined below.

Site Licensing Guidance Document

• Section 2.1 Evidence of GMP compliance - clarified with respect to use of alternative standards and/or accreditations;
• Section 3.0 Submission Management - clarified with respect to processing timelines for new applications, renewals, amendments and notifications;
• Section 3.1.3 Deficiencies in the Application - revised to include reference to the Risk Classification of NHP GMP Observations and its use as a tool for NHP stakeholders;
• Extracts of the Natural Health Products Regulations (NHPR) reintroduced where applicable;
• Appendix A - Guidance on how to obtain a Foreign Site Reference Number (FSRN) added;
• Removal of Health Canada recognized third-party auditors and associated audits, in line with the update above.

Good Manufacturing Practices Guidance Document

• Terminology and interpretation of GMP requirements have been further clarified;
• Examples of evidence that would be expected to demonstrate GMPs compliance have been added and/or clarified;
• Extracts of the Regulations have been reintroduced, where applicable;
• Appendix 5 - Risk Classification of NHP GMP Observations has been added.

Quality Assurance Report Form

• Consolidated questions relating to premises to improve clarity;
• Clarification regarding stability program requirements.

Implementation of Service Standards for Site Licensing

Based on the feedback received, the NNHPD revisited the feasibility of a 45-day service standard for all site licence applications; however, it has determined that a three-stream approach, based on the type of evidence provided and the associated effort involved in assessing an application, is more suitable. This approach will allow the NNHPD to more effectively predict workload and associated resource needs, resulting in more consistent review timelines and a greater level of predictability for all site licence applicants. This approach mirrors the product licensing approach taken by the NNHPD.

The revised service standards are outlined in Table 1 of the Site Licence guidance document and will apply to applications received on or after April 1, 2016. To assist stakeholders with the transition, the NNHPD is exploring hosting a Webinar series on the recent changes for site licensing. More information will be sent via the RSS feed in advance of the April 1, 2016 launch date.

Licensees claiming no activity at renewal

Under the Regulations, a company is not permitted to undertake licensable activities (i.e. manufacture, package, label or import) unless they have a valid site licence. The NNHPD acknowledges that some sites may not start activities immediately upon receiving a site license or may suspend operations temporarily once they have started. With the publication of service standards for the review of site licence applications by the NNHPD, applicants can now plan their business accordingly when it comes to obtaining and renewing their site licence. As such, to ensure that license holders are able to demonstrate compliance to the regulatory requirements, applications for renewal will be refused if no activity is claimed to have occurred in the 12 month period preceding a renewal.

Site Licence Renewal Reminder

The NNHPD will no longer be sending courtesy emails to site licence holders reminding them of their site licence expiration or obligation to submit an application for renewal as per section 36 of the Regulations. The applicant's obligation to renew remains, as per the Regulations. Manufacturers, packagers, labellers and importers cannot conduct activities without a valid site licence.

The NNHPD continues to explore improvements related to the site licensing application process, including moving towards an electronic means of receiving and processing applications and corresponding with applicants. Further information will be shared as this initiative is advanced.

If you have questions related to site licensing and/or the revised guidance documents, please submit them by e-mail to at nnhpd.consultation-dpsnso@hc-sc.gc.ca.

Original signed by
Jeannine Ritchot
Acting Director General