Single Window Initiative (SWI) - Survival Guide for Health Canada (HC) Controlled Substances

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—Office of Controlled Substances

The SWI data elements required for release include:

Intended end use

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

• Human therapeutic use
• Human clinical trial use
• Research or scientific use
• Special access
• Veterinary therapeutic use
• Agricultural use
• Processing
• Non-viable seed/grain
• Human consumption (food use)
• Manufacturing or industrial use
• Substances in a final product
• Resale

Canadian product category and required documents

A Canadian product category and documents are required, depending on the end use of the commodity.

Controlled substances with an end use of human therapeutic use

• Medical marijuana: import permit and either CDSA (Controlled Drug and Substances Act) or producer licence
• Narcotic: import permit and CDSA licence
• Controlled drug: import permit and CDSA licence
• Benzodiazepine: import permit and CDSA licence
• Class A precursor: import permit and Class A precursor license
• Class B precursor: no documents required

Controlled substances with an end use of human clinical trial use

• Medical marijuana: import permit and CDSA licence
• Narcotic: import permit and CDSA licence
• Controlled drug: import permit and CDSA licence
• Benzodiazepine: import permit and CDSA licence
• Restricted drug: import permit and CDSA licence
• Class A precursor: import permit and Class A precursor licence
• Class B precursor: Class B precursor registration

Controlled substances with an end use of research or scientific use

• Medical marijuana: import permit and CDSA licence
• Narcotic: import permit and CDSA Licence. Or test kit registration
• Controlled drug: import permit and CDSA licence. Or test kit registration
• Restricted drug: import permit and CDSA licence. Or test kit registration
• Benzodiazepine: import permit and CDSA licence. Or test kit registration
• Industrial hemp seed/grain: import permit and research licence
• Class A precursor: import permit and Class A precursor license or precursor authorization certificate
• Class B precursor: Class B precursor registration or precursor authorization certificate

Controlled substances with an end use of special access

• Narcotic: import permit and CDSA licence
• Controlled drug: import permit and CDSA licence
• Benzodiazepine: import permit and CDSA licence

Controlled substances with an end use of veterinary therapeutic use

• Narcotic: import permit and CDSA licence
• Controlled drug: import permit and CDSA licence
• Benzodiazepine: import permit and CDSA licence
• Class A precursor: import permit and Class A precursor license

Controlled substances with an end use of agricultural use 

• Industrial hemp seed/grain: import permit and industrial hemp licence

Controlled substances with an end use of processing

• Industrial hemp seed/grain: import permit and industrial hemp licence

Controlled substances with an end use of non-viable seed/grain

• Industrial hemp seed/grain: certificate of analysis (optional)

Controlled substances with an end use of human consumption (food use)

• Industrial hemp seed/grain: certificate of analysis
• Class A precursor: import permit and Class A precursor license

Controlled substances with an end use of manufacturing or industrial use

• Class A precursor: import permit and Class A precursor license
• Class B precursor: Class B precursor registration

Controlled substances with an end use of substance in a final product

•  Class A precursor: import permit and Class A precursor license

Controlled substances with an end use of resale

• Medical marijuana: import permit and either CDSA or producer licence
• Narcotic: import permit and CDSA licence
• Controlled drug: import permit and CDSA licence
• Restricted drug: import permit and CDSA licence
• Benzodiazepine: import permit and CDSA licence
• Industrial hemp seed/grain: import permit and industrial hemp licence
• Class A precursor: import permit and Class A precursor license
• Class B precursor: Class B precursor registration

Document reference

Although a copy of the documents may not be mandatory at time of release, it is strongly suggested that an image be provided.

• Import permit: permit number
• Marijuana for medical purposes regulations producer: licence number                                       
• Controlled drug and substances act (CDSA) licence: licence number
• Test kit registration: test kit registration number
• Industrial hemp licence: licence number
• Research licence: licence number
• Class A precursor licence: licence number
• Precursor authorization certificate: certificate number
• Class B precursor registration: registration number (if available) or provide generic LPCO Number ‘XXX’

Active ingredients

Products that contain ingredients regulated as controlled substances must provide details of the chemical identity of the ingredients.

Ingredient quantity

The quantity of each ingredient (unit of measure and percentage of concentration) must be provided.

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

• Brand name
• Manufacture date
• Batch/lot number

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.