Dear stakeholders,

The Natural Health Products Directorate (NHPD) has received just over 4600 Site Licence Applications (SLA) since 2004.  Most of which have critical evidence deficiencies that require the issuance of multiple information request notices.

To address some of the challenges associated with the review of these applications, the NHPD has developed a Process Improvement Project. The main component of this project was to determine Evidence Criteria. The Evidence Criteria were developed based on a number of critical evidence deficiencies the NHPD has frequently encountered since it began assessing SLA’s in January 2004. Many of these criteria were communicated to industry in the fall of 2006 via Communiqués and at the NHPD Winter 2007 Information Sessions.

Applicants should note that SLA’s are not being subjected to new evidence requirements. The NHPD thoroughly assesses all SLA’s to ensure that the evidence provided is appropriate to demonstrate compliance with Part 3, Good Manufacturing Practices (GMP), of the Natural Health Products Regulations (NHPR). The NHPD is simply modifying its assessment process to ensure that SLA’s with critically deficient evidence are identified at the earliest stage of the review process.

Information and tools related to these Evidence Criteria are available at the end of this Notice and can be used by applicants to ensure that the evidence portions of their SLA’s are not critically deficient and meet a minimum level of quality.

Next Steps

As of October 1st, 2010 the NHPD will perform an initial assessment on new site licence, amendment and renewal applications against the evidence criteria. SLA’s which do not contain any of the critical evidence deficiencies will remain in queue for a full GMP assessment of their new site licence, amendment or renewal application. For those containing critical deficiencies, applicants will be issued a Refusal Notice outlining the deficiencies.

The primary purpose of this Notice is to provide applicants with the Evidence Assessment Template to use as a tool to improve the quality of their future site licence, amendment and renewal applications.  The NHPD will also use this tool to issue refusal notices for all applications that are deemed inadequate.

The NHPD will continue to communicate progress on this site licence improvement project to applicants. Should you have any questions or concerns, please refer to the Instructions for Completing the Quality Assurance Report Form http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/forms_qar_instructions-eng.php  or send your enquiry to the Site Licence Enquiries email: sla.info.dle@hc-sc.gc.ca

The Natural Health Products Directorate
Health Canada

Example #1: Importation

The initial assessment of the domestic information is always conducted before any foreign site information. SLAs with critical evidence deficiencies in the domestic site information will not proceed and will receive a Refusal Notice immediately. If the domestic site information submitted meets the evidence criteria, the initial assessment is then conducted for all foreign sites listed on the SLA. Any foreign site with critically deficient evidence will be removed so that the SLA can proceed with the sites that meet a minimum level of quality. The SLA will remain in queue for a full GMP assessment provided that at least one foreign site has GMP evidence that meets the minimum criteria.

Evidence Assessment Templates – Site Licence Application & Site Licence Renewal

Prior to submitting their SLAs, applicants are strongly encouraged to cross check their application forms and supporting evidence against the criteria in the Evidence Assessment Templates below to ensure that it is not critically deficient and meets a minimum level of quality.

Respectfully,

The Natural Health Products Directorate

Health Canada