HEALTH CANADA SITE/
ESTABLISHMENT LICENSING
COVID-19 SL
Be Prepared for End of Temporary License Measures
As site licenses (SL) issued under the expedited attestation process are temporary, companies with an interim COVID-19 SL could be notified soon to stop manufacturing and importing hand sanitizers,
OR you should apply for a valid (Regular) SL to continue importing and manufacturing.
When notified, you will have only 60 days to apply before the temporary license will expire.
QMRS is here to help...
Our expertise during the last 20 years includes projects pertaining to; drug establishments, Medical Devices, Natural Health products and helping clients to become a licensed Marihuana producer.
- QMRS prepare the Site License Application and the “Quality Assurance Report” (for Natural Health Products).
- QMRS can assist foreign companies to obtain the “Foreign Site Reference Number (FSRN)”
- QMRS helps clients to become a licensed Marihuana producer.
- QMRS provide many types of training certificates
- QMRS conduct “Third Party Audit” and may issue a “Certificate of GMPs Compliance”.
In this page, you will read:
NATURAL HEALTH PRODUCTS SITE LICENSE REGULATIONS
A site licence is required for the physical site in Canada, if the business (person) manufacture or import a natural health product for sale.
To apply for a site license, applicant must provide to the NNHPD, a site license application, and Evidence of GMP Compliance.
EVIDENCE OF GMP
This may be demonstrated by one or more of the following:
Pre-cleared Evidence
Pre-cleared evidence includes:
1. Drug Establishment Licence (DEL). Applicant may submit a copy of their current DEL demonstrating compliance with the requirements of part C, of the Food and Drug Regulations.
By submitting a DEL, the site licence applicant is attesting to comply with the same standards for NHPs as for drugs.
2. Foreign Site Reference Number (FSRN) Authorization. The NNHPD may issue a FSRN to a foreign site that has demonstrated compliance to GMP Regulations via a separate FSRN application process. Once issued a FSRN, foreign site owners may authorize Canadian importers to reference their FSRN as an alternative to providing GMP evidence for their site.
3. Good Manufacturing Practices (GMP) Certificate from a Qualified Authority. A qualified authority is an authority member from a country, where Health Canada has a Mutual Recognition Agreement (MRA) regarding GMP for drug products, or an authority member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
LIST OF MUTUAL RECOGNITION AGREEMENT (MRA) AUTHORITIES
- Australia
- Austria
- Belgium
- Croatia
- Czech Republic
- Denmark
- Estonia
- Finland
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Liechtenstein
- Lithuania
- Malta
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovak Republic
- Slovenia
- Spain
- Sweden
- Switzerland
- United Kingdom
NOTE:
The NSF International Standard for Dietary Supplements Certificate has been found to partially cover the requirements of HC GMP Regulations and may be submitted in support of a site licence application along with other additional supporting information, which may include: the finished product testing and stability information.
Quality Assurance Report (QAR):
Is considered to be an attestation by the applicant that the site meets all the requirements of the GMP. It is prepared by the site quality assurance manager, who has the training, experience and technical knowledge relating to the activities conducted. The report, in brief, is based on the GMP requirements that set out in Health Canada GMPs guidelines.
NOTE:
Manufacturers of homeopathic products must submit additional GMP evidence that associated to homeopathic medicines.
Alternate GMP Standards (and/or Accreditation Bodies)
The NNHPD promotes independent on-site verification of compliance as it may provide a greater level of assurance that products sold in Canada meet appropriate standard of quality.
Therefore, applicants may submit other audits or inspection reports along with their QAR to assist in demonstrating compliance with the GMP Regulations.
Please note that, qualifications of the auditor or the person responsible of the inspection, parameters (standard) adopted for the audit, and corrective actions are also required.
To review QMRS audit approach, please click HERE, and if you want to look at the auditor profile, please visit this LINK.
NOTE:
Canadian importers are required to be licensed and the onus is on them to provide evidence that products coming from foreign sites meet Canadian GMP Regulations.
FOREIGN SITE REFERENCE NUMBER
A Foreign Site Reference Number (FSRN) is issued by Health Canada to a manufacturer, packager and labeler of NHPs located outside of Canada, referred to as a foreign site. A FSRN indicates that the foreign site is found to be in compliance with the GMP Natural Health Products Regulations. The FSRN application will benefit the Canadian importer and the foreign sites by:
1. Allowing direct communication between HC and the foreign site, maintaining confidentiality of the information provided;
2. Saving time, money and resources for foreign sites engaged with multiple Canadian importers by eliminating the need to supply the site GMP data to each importer several times a year.
3. Assessing the GMP compliance of a foreign site in advance, will also benefit the importer’s subsequent site license application.
4. A FSRN is considered pre-cleared evidence when referenced in support of an importer’s site license applications, and is therefore subject to a shorter service standard.
End of Temporary License Measures
Manufacturers, and importers will require a valid SL once the regular supply of hand sanitizers stabilizes.
Companies with an interim COVID-19 SL under the previous expedited attestation process will be notified when the interim period ends (when demand of alcohol-based hand sanitizers stabilizes).
When notified, you will have 60 days to:
1. Stop manufacturing, importing, packaging, labelling or distributing alcohol-based hand sanitizers.
2. Apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application.
Certainly, QMRS can assist you to transfer the Temporary license to a regular one.
Applying for A Foreign Site Reference Number
The FSRN application process requires foreign sites to supply the same types of evidence of GMP compliance as Canadian manufacturers in support of their application.
To apply for a FSRN, applicants must provide an application to the NNHPD, with the evidence of GMP compliance for the site.
Foreign Site Reference Number Authorization Form
For each application, the FSRN holder should provide each Canadian importer with a completed Foreign Site Reference Number Authorization Form to allow the NNHPD to access the previously assessed GMP information for the foreign site in support of any application submitted by the importer.
The importer, in turn, will provide the authorization form to the NNHPD as part of their new site licence, renewal or amendment application.
QMRS EXPERTISE
In brief, whether you are a manufacturer or importer QMRS can assist you to fulfill your regulatory needed.
- QMRS helps companies to obtain Health Canada Site/Establishment License.
- QMRS can assist foreign companies to obtain the “Foreign Site Reference Number (FSRN)”.
- QMRS helps clients to become a licensed Marihuana producer.
- QMRS assists clients to establish the needed SOPs pertaining to drug GMPs (Our sources are the US FDA, Health Canada, and the principles of GMP as set out in the WHO guidelines).
- QMRS audits manufacturing sites and may award the facility a “Certificate of GMPs Compliance”.
- QMRS provides many types of training certificates related to Food and Drug regulations.
- For more information:
- please contact us on 613 695 1967
- or Just send us an email at: jalal@qmrs.com
