Single Window Initiative – Data Element Rationales
Health Canada

Consumer Product Safety

Importer's General Telephone Number
This field is optional and may assist HC in making a release decision.
Importer's Contact Email
This field is optional and may assist HC in making a release decision.
Importer Contact Name
This field is optional and may assist HC in making a release decision.
Importer Contact Telephone Number
This field is optional and may assist HC in making a release decision.
Importer Contact Email Address
This field is optional and may assist HC in making a release decision.
LPCO Type / Authorization Type
This field is optional and may assist HC in making a release decision.
LPCO Number
This field is optional and may assist HC in making a release decision.
File
This field is optional and may assist HC in making a release decision.
Manufacturer Name and Address
This field is optional and may assist HC in making a release decision.
Manufacturer Contact Name
This field is optional and may assist HC in making a release decision.
Manufacturer Contact Telephone Number
This field is optional and may assist HC in making a release decision.
Manufacturer Contact Email Address
This field is optional and may assist HC in making a release decision.
GTIN Number
This field is optional and may assist HC in making a release decision.
Brand Name
This field is optional and may assist HC in making a release decision.
Product Name
This field is optional and may assist HC in making a release decision.
Manufacture Date
This field is optional and may assist HC in making a release decision.
Intended Use
Data required before decision can be made. It is used to determine if product meets the definition of Consumer Product or Cosmetic under the CCPSA or the FDA, respectively.
Commodity Type
Data required before decision can be made. It is used to determine if product meets the definition of Consumer Product or Cosmetic under the CCPSA or the FDA, respectively.
Batch/Lot Number
This field is optional and may assist HC in making a release decision.
Unit Size and Unit of Measure
This field is optional and may assist HC in making a release decision.

Human Drugs

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.).
File
Optional but allows for clearer identification of the product and may ease need for referral.
GTIN Number
Optional but allows for clearer identification of the product and may ease need for referral.
Brand Name
Brand name is required to be on the product label.
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Commodity Type
The Canadian Product Category, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number required.
Manufacture Date
Manufacture date is required to be on the product label. This information will allow for timely recall postings for goods imported into Canada.
Batch/Lot Number
Batch/lot number is required to be on the product label. This information will allow for timely recall postings by having knowledge of the batches/lots imported into Canada.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO  Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.).
File
Optional but allows for clearer identification of the product and may ease need for referral.

Natural Health Products

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.).
File
Optional but allows for clearer identification of the product and may ease need for referral.
GTIN Number
Optional but allows for clearer identification of the product and may ease need for referral.
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Commodity Type
The Commodity type, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Brand Name
Brand name is required to be on the product label.
Manufacture Date
Manufacture date is required to be on the product label. This information will allow for timely recall of goods imported into Canada.
Batch/Lot Number
Batch/lot number is required to be on the product label. This information will allow for timely recall postings by having knowledge of the batches/lots imported into Canada.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.).
File
Optional for Health Product Border Compliance Program.

Importation of Controlled Substances and Precursors

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
This is optional, but providing an image may facilitate communication in case of a referral
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Brand Name
Enables OCS to accurately identify products in order to validate permit status and make a decision on goods admissibility.
Batch/Lot Number
Batch/lot number is required to be on the product label. This information will allow for timely recall postings by having knowledge of the batches/lots imported into Canada.
Product Category
The Canadian Product Category, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number required.
Producer/Manufacturer Name and Address
Producer/Manufacturer Name and Address required as it will improve communication in case of a referral.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
This is optional, but providing an image may facilitate communication in case of a referral
Active Ingredient
PGA needs to be informed of the ingredient  being imported
Ingredient Quantity
Conditional. Details regarding the chemical identity of the ingredient are required
Ingredient Quality
Conditional.  This field is need only if the concentration is less than 100%

Veterinary Drugs

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.).
File
Optional but allows for clearer identification of the product and may ease need for referral.
GTIN Number
Optional but allows for clearer identification of the product and may ease need for referral.
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Brand Name
Brand name is required to be on the product label.
Batch/Lot Number
Batch/lot number is required to be on the product label. This information will allow for timely recall postings by having knowledge of the batches/lots imported into Canada.
Commodity Type
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Manufacture Date
Manufacture date is required to be on the product label. This information will allow for timely recall of goods imported into Canada.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.).
File
Optional but allows for clearer identification of the product and may ease need for referral.

Radiation Emitting Devices

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional
FDA Product Code
Optional
Model Designation
 Necessary for identifying radiation emitting device class or product
Commodity Type
The Canadian Product Category, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number required.
LPCO Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Optional
File
Optional

Blood and Blood Components

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional but allows for clearer identification of the product and may ease need for referral
GTIN Number
Optional but allows for clearer identification of the product and may ease need for referral
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Commodity Type
The Commodity type, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Expiry Date
ID's any concern with its use
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional but allows for clearer identification of the product and may ease need for referral

Cells, Tissues and Organs

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional but allows for clearer identification of the product and may ease need for referral
Exception Process
Importer to indicate exception from the licensing requirements if applicable. For example, importers of medical devices do not require a Medical Device Drug Establishment if they are retailers, clinics, etc.  In addition, lymphophematopoietic cells and organs do not need to be processed by a registered establishment. 
GTIN Number
Optional but allows for clearer identification of the product and may ease need for referral
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Commodity Type
The Commodity type, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Expiry Date
Identifies any concern with use
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional but allows for clearer identification of the product and may ease need for referral

Active Pharmaceutical Ingredients

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address  
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Reference Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
GTIN Number
Optional for Health Product Border Compliance Program
Manufacture Date
Manufacture date is needed to make the pre-border admissibility determinations given that inspectors cannot visually inspect the product label in SWI
Commodity Type
The Canadian Product Category, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number required.
Brand Name
Brand name is requested so that the inspectors can perform compliance verification prior to the shipment's arrival. This results in an expedited admissibility determination.
Batch/Lot Number
Batch/Lot number is needed to make the pre-border admissibility determinations given that inspectors cannot visually inspect the product label in SWI
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
Ingredients
PGA needs to be informed of the ingredient  being imported
Ingredient Quantity
Ingredient Quantity is needed to make the pre-border admissibility determinations given that inspectors cannot visually inspect the product label in SWI
Ingredient Quality
Ingredient Quality is needed to make the pre-border admissibility determinations given that inspectors cannot visually inspect the product label in SWI

Donor Semen

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
File
Optional but allows for clearer identification of the product and may ease need for referral
Commodity Type
The Commodity type, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
File
Optional but allows for clearer identification of the product and may ease need for referral
Processor Declaration
Required labelling requirement

Medical Devices

Importer Contact Name
PGAs to contact the importer for IID clarification.
Importer Contact Telephone Number
PGAs to contact the importer for IID clarification.
Importer Contact Email Address
PGAs to contact the importer for IID clarification.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional but allows for clearer identification of the product and may ease need for referral.
Exception Process
Importer to indicate exception from the licensing requirements if applicable. For example, importers of medical devices do not require a Medical Device Drug Establishment if they are retailers, clinics, etc.  In addition, lymphophematopoietic cells and organs do not need to be processed by a registered establishment. 
GTIN Number
Optional but allows for clearer identification of the product and may ease need for referral.
Unique Device Identifier (UDI) Number
Optional but allows for clearer identification of the product and may ease need for referral.
Commodity Type
The Commodity type, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
Manufacture Date
Manufacture date required to be on the product label. This information will allow for timely recall of goods imported into Canada.
Brand Name
Brand name is required to be on the product label.
Model Number
Optional but allows for clearer identification of the product and may ease need for referral.
Batch/Lot Number
Batch/lot number is required to be on the product label. This information will allow for timely recall postings by having knowledge of the batches/lots imported into Canada.
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Importer must ensure that the product has a valid licensing number demonstrating its authorization for sale/use in Canada as applicable (DIN, No Objection Letter, etc.)
File
Optional but allows for clearer identification of the product and may ease need for referral.

Pesticides

Importer Contact Name
Improves communication in case of uncertainties in regards to goods admissibility.
Importer Contact Telephone Number
Improves communication in case of uncertainties in regards to goods admissibility.
Importer Contact Email Address
Improves communication in case of uncertainties in regards to goods admissibility.
LPCO Type / Authorization Type
Optional as long as LPCO reference number is provided.
LPCO Number
Enables PMRA to verify numbers in order to validate LPCO and make decision on goods admissibility.
File
Optional
Exception Process
Allows regulated but non registered goods to be imported.
Manufacturer Contact Name
Manufacturer Name and Address required as it will improve communication in case of a referral.
Manufacturer Contact Telephone Number
Manufacturer Name and Address required as it will improve communication in case of a referral.
Manufacturer Contact Email
Manufacturer Email required as it will improve communication in case of a referral.
Product Name
Data element that allows identification of the commodity and helps to identify the regulated pesticide. Enables PMRA make a decision on goods admissibility.
Brand Name
Enables PMRA to accurately identify end use products in order to validate registration status and make a decision on goods admissibility.
Manufacture Date
Manufacture date is needed to make the pre-border admissibility determinations given that inspectors cannot visually inspect the product label in SWI
Batch/Lot Number
Batch/lot number is required to be on the product label. This information will allow for timely recall postings by having knowledge of the batches/lots imported into Canada.
Intended Use
The Intended Use, declared by the broker/importer, will impact the LPCO Type and LPCO Reference Number.
CAS Number
Optional
UNDG
Optional
Commodity Type
Refines and help to identify the responsible PGA that regulates the commodity being imported. Enables to identify goods regulated by the PMRA.
Manufacturer Name and Address
Manufacturer Name and Address required as it will improve communication in case of a referral.
Manufacture Contact Name
Manufacturer Name and Address required as it will improve communication in case of a referral.
Manufacturer Contact Telephone Number
Manufacturer Phone Number required as it will improve communication in case of a referral.
Manufacturer Contact Email Address
Manufacturer Email required as it will improve communication in case of a referral.
LPCO Type / Authorization Type
Importer must ensure that the product meets the appropriate licensing type to be imported.
LPCO Number
Enables PMRA to verify and validate LPCO in order to make decision on goods admissibility.
File
Optional
Active Ingredient
Additional data element allowing PMRA to cross-reference and validate information in order to assess goods admissibility.
Ingredient Quantity
Allows verifying that it is conform to the conditions of registration respecting its composition.
Ingredient Quality
Allows identification of the concentration of the active component and total amount imported to help identify the regulated pesticide.
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