If you are doing business in the health care industry in Canada, you must follow all regulations from Health Canada. Obtaining a site license from Health Canada is necessary for businesses operating in the health care industry in Canada.
Engage our NHP site licensing experts to mitigate your concerns about site licensing, handle necessary functions of the importer of record and manage other activities as necessary.
Did you know that there are site license renewal restrictions? Health Canada may choose to renew a Site Licence for a shorter period of time than the initial licence. This could be due to changes in standards or product needs, or if the applicants has not complied with any of the requirements and conditions attached to their current licence. It is important to note that all other activities related to the issuance of a Site Licence must be completed as required prior to applying for renewal.
If you are a Canadian company engaged in manufacturing, packaging, labeling, or importing a natural health product for sale, then you need to hold a valid site license issued by the Natural and Non-Prescription Health Products Directorate (NNHPD).
Note that it is mandatory for all packagers, foreign manufacturers, and labelers of natural health products to be annexed to the site license of a Canadian importer.
A Site Licence is a type of permission issued by Health Canada to those businesses engaged in activities such as selling, labeling, packaging, and importing drugs or medical devices. These activities are regulated under the Food and Drugs Act and its associated regulations. All companies must have a valid Site Licence before they can engage in these activities.
To obtain a Site Licence, businesses must provide Health Canada with detailed information regarding their operations. This may include employee training documents, detailing of technical processes and documentation of compliance with good manufacturing practices (GMPs). Companies must also pass an on-site inspection by Health Canada to demonstrate their compliance with the Food and Drugs Act and its associated regulations.
The process for applying for a Site Licence involves submitting an application to Health Canada. This can be done through the Drug Submission and Information System (DSIS) portal. The application must include detailed information pertaining to the business’ compliance with GMPs and other requirements, as well as any associated fees. Upon approval, applicants will receive a licence that is valid for up to three years.
After submitting your application, Health Canada will conduct a pre-inspection of your facility before issuing a Site Licence. This will involve assessing the safety and security protocols in place, as well as any licences that have been issued in the past. After that, Health Canada will enter into negotiations with you regarding any requirements for obtaining a licence. Once all parties are satisfied, the final licence will be issued.
Determining the eligibility requirements for a Health Canada site license can be done by looking at your business’s or research operation’s specific activities, risks, and management systems. Your operation must comply with all applicable regulations set out by Health Canada to be considered eligible. Additionally, you may need to submit additional documentation that describes how you would manage any potential risks associated with your operations.
When you are ready to submit your site license application, the process is quite straightforward. Gather all the necessary documents and information, create an account on the Drug Submission System (DSS), and complete the online form. Once you’re done, apply to DSS. The entire process can be completed in under an hour with the help of tutorial videos available on Health Canada’s website.
As part of the site license application process, you may be required to attend an assessment or inspection. To ensure that your assessment or inspection goes smoothly, it’s essential to prepare ahead of time and be aware of the rules and regulations associated with a Health Canada site license. Take some time to read through Health Canada’s requirements for a site licensing inspection and make sure your facility is compliant before the assessment begins. Additionally, having a checklist of items to review during the assessment can help ensure that nothing is missed.
Amendments to your existing Health Canada site license may be requested at any time due to changes in regulations. To comply with all requests, it’s important to ensure that the amendment is clearly understood by the applicant and all relevant parties. Be sure to solicit feedback from everyone involved before submitting the amendment for approval. Additionally, review and update any documents related to the amendment so they accurately reflect the requirements of Health Canada.
We have assisted many companies in obtaining a natural health product site license with a 100% customer satisfaction rate. We have helped clients in preparing NHP license applications, SOPs and supporting documentation to assure they can comply with the site license regulations and Good Manufacturing Practices. We assist in:
A site license allows the holder the authority to package, manufacture, label, and import NHPs in Canada. All these activities must be carried out according to the good manufacturing practices outlined in the Natural Health Product Regulations.
This system requires that all manufacturers, packagers, importers, and labelers be licensed. The sites must have procedures in place for product recalls, distribution records, and the storage, handling, and delivery of all their products.
Canadian companies that are engaged in manufacturing, packaging, labeling, or importing of natural health products for sale are required to hold a valid site license that is issued by the Natural and Non-Prescription Health Products Directorate (NNHPD). These licenses are only used for activities within Canada.
The NNHPD will issue a site license for; manufacturing, labeling, packaging, and importing activities related to Natural Health Products.
SOPs and supporting documentation such as quality assurance reports), GMP compliant quality systems, GMP audit records, NHP site license amendments and NHP site license annexations for foreign sites.
Foreign NHP manufacturing sites must be annexed to an importer’s valid site license, and attest to following Good Manufacturing Practices (GMP).
Good manufacturing practices (GMP) are part of quality assurance and ensure that natural health products are consistently produced, controlled and meet the quality standards for their intended use.
It is advisable to keep your import record for six years following the date of import as they can be audited by customs at any point during this time. Since you will be acting as the ‘Importer of Record’, you will be liable for the accuracy and completeness of the import declaration. Also, you will be responsible for the payment of applicable taxes and duties in Canada.
The Government of Canada may levy extra fees for these services.
An importer of record is required if you wish to manufacture, package or label NHPs outside of Canada.
Quality IMPORT Solutions can act as your importer of record! Any business that holds a valid site license issued by the NNHPD can act as an importer of record, so long as any domestic warehouse/storage facility is annexed to the importer’s site license as well as any foreign manufacturing sites.
We will serve as your formal Quality Assurance (QA) personnel or informal advisor on all matters associated with QA. So, leverage our expertise and take a proactive and anticipatory approach towards quality and regulatory requirements not only to prevent your site license from being revoked, but for the health and safety of consumers.
Are you a manufacturer, labeller, packager, or importer of NHPs? Get in touch with us today. Our quality and compliance experts will assist you with all aspects of natural health product nhp site licensing or product registration. You can fill in the form below and leave us a message. Our specialists will respond to you soon.