Numerous changes may impact you. As an importer, here is what you need to know and do.
Health Canada is the last government department to move to the Single Window Initiative (SWI). On August 17, 2020 all legacy Other Government Departments (OGD), including Health Canada, will be decommissioned by the Canada Border Services Agency (CBSA).
The immediate implication is that All Pre-Arrival Release (PARS) requests with regulated goods for Health Canada will have to be submitted by the SWI. (For more information on SWI refer to Single Window Initiative – Data Element Rationales (Health Canada) )
What is Health Canada responsible for?
Health Canada is responsible for overseeing and administering import requirements for the following programs:
Consumer Product Safety
Human Drugs
Natural Health Products
Importation of Controlled Substances and Precursors
Veterinary Drugs
Radiation Emitting Devices
Blood and Blood Components
Cells, Tissues and Organs
Active Pharmaceutical Ingredients
Donor Semen
Medical Devices
Pesticides
What do you, the importer, have to do?
The implications of recent changes must be evaluated case by case. Your tariff classification, intended end-use, product category and shipment details must be reviewed as a priority.
Correct tariff classification is an important factor in determining the appropriate Health Canada program and the required reporting requirements. It can be complex: each Health Canada program has its own reporting criteria. If the conditions for reporting are met there is a requirement to transmit and report those details to CBSA through SWI.
We require shipment specific details in order to determine if the goods to be imported are subject to any PGA reporting requirements. Due to the detailed nature and length of time to perform these reviews we require as much lead time as possible in order to prevent release delays.
Exactly which details are needed?
Complete and detailed descriptions can include, but are not be limited to, make (brand name of product), batch number if available, and date of manufacture. Product registration numbers such as Natural Product Number (NPN), Drug Identification Number (DIN) or other information that identifies your product such as Chemical Abstracts Service (CAS) Chemical Number should be provided where applicable.
This is complex: need help? Reach out to cdnregulatory@willsonintl.com
Links to Other Resources
The following links provide information that will assist importers in determining the information that will need to be provided at the time of release.
Single Window
Single Window Initiative – Data Element Rationales (Health Canada) – Provides details that must be included in the SWI submission
Regulated Commodities. Tables for: Data Element Matching Criteria, Product Category Reference Codes, and Intended use Codes.
Regulated Commodities — Data Element Matching Criteria Tables (Health Canada) – Provides list of subject HS tariff classification and related HC program including intended end-use and Canadian Product Category
Regulated Commodities – Reference Code Tables (Health Canada) (Product Category) – Identifies the product category for imported goods based on HS tariff classification
Regulated Commodities – Reference Code Tables (Health Canada) (Intended Use Code) – Identifies the intended use for imported goods based on HS tariff classification