NHP Site Licence Application (SLA) Consulting Services

NHP Site Licence Application Consulting Services

What is a Site Licence (SL)?

Who must apply for a Site Licence?

Our Site Licence Application (SLA) services

NHP Site Licence application (SLA) consulting services

 What is a Site Licence (SL)?

This licence is to demonstrate that you have a quality assurance (QA) program called Good Manufacturing Practices (GMP), that is acceptable to Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). This demonstrates that one has procedures & associated quality records in place respecting manufacturing, storage and distribution, as well as for product recalls (among other requirements).

It is also for the NNHPD to ensure they know about all the sites where the products are manufactured, packaged, labelled, imported and stored.

A Site Licence Application (SLA) requires the applicant to submit a Quality Assurance Report (QAR) outlining their GMP program, along with examples of certain written Standard Operating Procedures (SOPs) and any associated forms or checklists demonstrating compliance to those SOPs.

This QA Report must be completed by someone who meets the NNHPD’s minimum qualifications in education, training & experience, in order to protect the quality of the finished product.

Who must apply for a Site Licence?

Anyone in Canada who is involved in the manufacture, packaging, labelling and/or importation of NHPs, must obtain a Site Licence.

Site Licences will not be issued to foreign sites, however they must still adhere to GMP, and will be appended to the Canadian importers Site Licence..

Distributors do not require a SL, however they must also still adhere to GMP aspects that apply to them, such as sanitation & hygiene, storage & distribution records, adverse reaction reporting, and product recall.

Our Site Licence Application (SLA) services

As mentioned above, one must submit a Quality Assurance Report (QAR) outlining your GMP program in detail. It is therefore a lengthy document.

In order to fill out the QAR, one must have first fully implemented GMP for NHPs. However, if your GMP program has not yet been developed, please refer to our QA Implementation & Training Services. Alternatively, we also offer Third Party GMP Auditing services, if you feel that your present QA program might not yet meet the GMP requirements within the QAR.

We then summarize that information throughout the QAR, identify all relevant Standard Operating Procedures (SOPs) specific to that section of the QAR, and attach samples of records used to demonstrate adherence to those SOPs.

Since this documentation must then be attested to, by a QA Person (QAP) who meets the NNHPD’s qualifications for education, training & experience, please contact us, to obtain a detailed list of our qualifications specific to these requiriements.

We will ensure your foreign manufacturer’s / packager’s / labellers also meet the NNHPD’s regulations for GMP. See our Third Party GMP Auditing services.

Once the information has been submitted, the NNHPD will always come back with requests for further information & documentation. This is because the QAR is just their initial minimal information / documentation requirements. We will then work with you and any contract manufacturers to acquire, review and submit that information to the NNHPD.

Upon receipt of your Site Licence, we can the assist you going forward via our QA Person (QAP) Services, as well as assist in the annual renewal applications.

Site License applicationWhy use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Unless your company is planning on submitting at least 30 product licence applications (PLAs), it’s best to contract this service out vs. spending well over 60 hours figuring out the process and all the paperwork.

Based in British Columbia, but covering all of Western Canada.

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