December 1, 2015, the Natural and Non-prescription Health Products Directorate (NNHPD) released their latest Site Licensing Guidance Document (Version 3).

The most significant change to the guide involves the introduction of new performance standards for site licence application assessments based on a new 3 Class system. As of April 1, 2016, Site licence submissions will be processed according to the following:

Class I applications – Cases where all supporting GMP evidence is pre-cleared (DELs, GMP Certificates of Compliance, FSRNs, NSF USFDA Dietary Supplement GMP based audits) – will qualify for a 30 day assessment period, plus a 5 day administrative review time.

Class II applications – Cases where at least one of the sites in the application is supported by a Quality Assurance Report for up to a maximum of 9 sites – will qualify for a 60 day assessment period, plus a 5 day administrative review time.

Class III applications – Cases where at least one of the sites in the application is supported by a Quality Assurance Report for an application with 10 or more sites – will qualify for a 60 day assessment period, plus a 5 day administrative review time.

These timelines apply to amendments and renewals, as well as to new licence applications.

On the surface, this appears to be good news: Established performance standards mean greater predictability, allowing companies to better plan their product launches. But is this really an improvement in NNHPD performance? First, it is important to realize that the above timelines are in business days, not calendar days. Therefore, once one has factored in weekends, the odd holiday, and the odd Information Request Notice (IRN), you arrive at an average review time of three months for Class I and four months for Class III applications. Given that the typical review time for site licence applications has been three months on average for the last several years – this is not much of an improvement.

Second, these improvements come with a price. In consideration of devoting the time necessary to meet the new timelines, the NNHPD has decided that:

• They will no longer notify Site Licence holders in advance of their pending renewals. Applicants should therefore ensure that they mark their calendars to avoid missing the renewal deadline
• Only one IRN, or in rare situations two, will be issued during the site licence assessment
• Applicants will be given only 15 days to respond to IRNs instead of the hitherto 30 days
• Renewal applications must be submitted “X” days in advance of the expiration date where “X” is the Class performance timeline. For example, if a company is submitting a renewal application that falls under Class II, they must submit the renewal 65 business days prior to the site licence expiration date. Exactly how the NNHPD will enforce this form a legal perspective remains unclear. Section 35 of the Regulations states that a site licence will expire “unless it is renewed in accordance with Section 36”. Section 36 states that the Minister shall renew the licence if an applicant submits their renewal “no later than 30 days before the day on which the licence expires”. Therefore, if a company meets their obligation under Section 36, it is hard to see how the NNHPD can allow the site licence to expire given their obligation under Section 35.

The new guidance document – as a whole represents a reduction, rather than an increase in NNHPD oversight of the site licencing process. A decade ago, applicants had to submit a comprehensive 28 question QAR when applying for or renewing a site licence. A few years later, this was streamlined to a 22 Question QAR, which was then condensed to a Summary of Net changes (for renewals) – which has now finally been pared down to what essentially amounts to a simple 10 page attestation form. Given that there is hardly anything left for the NNHPD to actually assess, one would have expected more from the Guidance Document with respect to improved application review times.

Still, to be fair to the NNHPD, much of the watering down of oversight when it comes to assessing compliance with Site Licence and GMP requirements stems from budget cuts, as they are working with very limited resources. The bottom line is that, more than ever before, it falls to industry to ensure that they understand their obligations under Site Licencing and Good Manufacturing Practices, and that they are meeting these obligations.

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products. We can be reached at 1-866-647-3279 or info@dicentra.com.