On December 1, 2015, Health Canada released a new Site Licensing Guidance Document. The guidance document outlines how the Natural and Non-prescription Health Products Directorate (NNHPD) manages site licence applications submitted in accordance with the Natural Health Products Regulations (the “Regulations”). As a result, there are new processes, timelines and forms for site licence applications and renewals.
Various types of evidence can demonstrate good manufacturing practices
Under the new guidance, applicants may demonstrate compliance with the good manufacturing practices (“GMPs”) established in Part 3 of the Regulations by submitting a completed Quality Assurance Report (“QAR”). Alternatively, it may be possible to rely on:
- Drug Establishment License (“DEL”),
- Foreign Site Reference Number (“FSRN”) Authorization,
- GMP Certificate from a Qualified Authority (i.e. a recognize authority from another country or an authority member of the Pharmaceutical Inspection Cooperation Scheme), or
- NSF International Standard 173, Section 8 Dietary Supplements Certificate with certain additional supporting documents;
The QAR form can be accompanied by other audits or inspection reports to assist in demonstrating compliance, but this is not required and accreditations not identified above are not sufficient on their own to demonstrate compliance with the Regulations.
In addition, the QAR form itself has changed substantially. For example, applicants are no longer expected to provide detailed responses describing compliance or a rationale for non-compliance. There is also less supporting documentation expected to accompany QAR, though records and supporting documents are generally expected to be available to Health Canada upon request and are still required to accompany site licence renewals.
The evidence demonstrating GMP compliance will affect timelines
The new guidance also sets out new service standards and timelines, based on the type of GMP evidence and the number of sites to be included on the licence. All new applications, renewals or amendments will be examined for administrative completeness in five business days, at which point an Application Acknowledgement Letter or a Rejection Notice – Administrative Deficiency will be sent to the applicant. Following the initial examination, all submissions will be assessed and decided upon in the following number of days:
- If using pre-cleared evidence for every site – 30 days;
- If the application includes 1-9 sites and uses a QAR as evidence – 60 days; and
- If the application includes 10 or more sites and uses a QAR as evidence – 90 days.
The new service standards apply to all applications received on or after April 1, 2016.
It’s also important to note that the above service standards apply to both initial applications and renewals. As the NNHPD no longer sends renewal reminder emails to site licence holders, the onus is on the licence holder to track their renewal date and submit the renewal package far enough in advance of licence expiry, based on the applicable service standards.