Single Window Initiative (SWI): Survival guide for Health Canada (HC) Cells, Tissues, and Organs
The new SWI landscape
The Single Window Initiative means several changes for importers:
- how you need to submit documentation is in flux;
- when that documentation is needed has changed; and
- which documentation is required is also shifting.
Our goal is to help you understand what is expected for the new “how, when, and what” of SWI requirements relating to the items you ship. These updates guide importers through specific commodities or categories of commodities, and the Participating Government Agencies (PGAs) that are affected.
How, when, and what
- Single Window Initiative requires all import documentation to be prepared and submitted before the shipment reaches customs.
- SWI is a new way of submitting documentation. All docs will be submitted using the Integrated Import Declaration (IID). Some of the requirements for how you submit are changing. For example: some documents that needed to be faxed now require an uploaded electronic image or just the document number.
- There may be changes to which documents are required under SWI.
- The launch date of SWI is still unknown, but it’s time to get proactive and adjust your workflow to ensure paperwork is ready before you ship.
Why importers need to know
Under the new SWI, it’s important that you understand which Participating Government Agencies (PGAs) are regulating your products. Some products are regulated by multiple PGAs, and the PGAs regulating your products may have changed under SWI. Additionally, each PGA and the CBSA can issue penalties for incorrect and missing documents. Understanding what information and documentation is needed for clearance will make the clearance process into Canada smoother and more efficient.
Health Canada (HC): Cells, Tissues, and Organs
The SWI data elements required for release include:
Intended end use
Human therapeutic use
Canadian product category
The categorization to which the goods belong.
- Cells
- Tissues
- Organs
Document type
The product category combined with the intended end use establishes what LPCO (License, Permits, Certificates, Other) documentation is required.
Intended use: human therapeutic use
Cells: importer establishment registration (optional) AND exporter establishment registration (optional)
Tissues: importer establishment registration (optional) AND exporter establishment registration (mandatory)
Organs: importer establishment registration (optional) AND exporter establishment registration (optional)
Document type and reference
Importer establishment registration: importer establishment registration number
Exporter establishment registration: exporter establishment registration number
Exception process: Lymphohematopoietic cells and organs
Lymphohematopoietic cells and organs are exempt from having to provide establishment registration numbers.
Importer contact information
Health Canada requires contact information for all imports. Importer Name, telephone number, or email address is required for release.
GTIN (Global Trade Identification Number)
Although not required, this information would allow a clearer identification of the product and facilitate communication in case of referrals.
For SWI, being proactive is your best strategy—gather all your information and documentation as far in advance as possible. Importers who know the requirements for the products they’re importing, and understand the new processes under SWI, will have a much smoother import experience.
As you adjust to the new requirements and workflow of the Single Window Initiative, we're here to help. Our customs team is ready to help you understand the SWI and its new requirements for your commodities—contact us today!
SWI. It's what we do.
