Single Window Initiative (SWI): Survival guide for Health Canada (HC) Human Drugs

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) Human Drugs

The SWI data elements required for release from Health Canada’s (HC) Human Drugs program include:

Intended end use

The intended end-use of human drugs must be provided and, depending on the end use, additional details and documents may be required.

• Human therapeutic use
• Special access
• Human clinical trial use
• Research & development
• Other

Canadian product category

Depending on the end use code selected, a Canadian product category must be provided:

• Human drug other than radiopharmaceutical
• Radiopharmaceutical
• Phase I clinical trial drug
• Phase II clinical trial drug
• Phase III clinical trial drug
• Phase IV clinical trial drug

Human drugs with an end use of:

• Human therapeutic use
• Special access
• Research & development
• Other

Require a Canadian product category of either:

• Human drug other than radiopharmaceutical, or
• Radiopharmaceutical

Human drugs with an end use of:

• Human clinical trial use

Require a Canadian product category of either:

• Phase I clinical trial drug,
• Phase II clinical trial drug,
• Phase III clinical trial drug, or
• Phase IV clinical trial drug

Document reference

Although a copy of the documents are not mandatory at time of release, it is strongly suggested that you provide an image.

• Establishment license (EL): establishment license number required
• Drug identification (DI): drug identification number (DIN)
• Letter of authorization (LOA): LOA number
• Clinical trial no objections letter (CT NOL): CT NOL number

Document type

The required document type depends on several factors. Please read the following carefully to ensure you’re including the correct document type(s) for your product.

• An establishment license and drug identification is required for human drugs with an end use of human therapeutic use that have a Canadian product category of Human drug other than radiopharmaceutical.
• An establishment license is required for human drugs with an end use of human therapeutic use that have a Canadian product category of radiopharmaceutical.
• A letter of authorization is required for human drugs with an end use of special access that have a Canadian product category of Human drug other than radiopharmaceutical.
• A clinical trial no objection letter is required for human drugs with an end use of Human clinical trial use that have a Canadian product category of Phase I clinical trial drug, Phase II clinical trial drug, and Phase III clinical trial drug.
• A drug identification is required for human drugs with an end use of Human clinical trial use that have a Canadian product category of Phase IV clinical trial drug.
• No documentation is required for human drugs with an end use of research & development, or other.

Brand name

The brand name of the commodity must be provided.

Although the following elements are not mandatory for the release of the commodity, they may be asked for and should be supplied:

• Manufacture date: the manufacture date may be required
• Batch/lot number: the batch and lot number may be required
• GTIN: Global Trade Identification Number. Active pharmaceutical ingredients can be identified through their GTIN GS1 Asset Identifier or UDI Number. GTIN number is not required to be submitted, but will give CBSA a clearer identification of the product.

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.