2019-2020 Compliance Monitoring Project: Advance notice of importation process
Health Canada actively monitors the compliance of regulated parties and health products in Canada.
We looked at how importers who submitted an advance notice of importation (ANI) are complying with the labelling requirements. Learn about our compliance monitoring project, what we found and what actions we took.
On this page
- Why this project was done
- What we reviewed
- What we found
- What enforcement actions we took
- What will we do with the results
- For more information
Why this project was done
Non-compliant cosmetics and non-compliant drugs, including natural health products (drugs) may not be imported for sale. This is outlined in section 5 of the Cosmetic Regulations (CR) and section A.01.040 of the Food and Drug Regulations (FDR).
However, section 9 of the CR and section A.01.044 of the FDR set out 2 conditions under which non-compliant cosmetics and drugs may be imported:
- the importer gives advance notice to a Health Canada inspector of the proposed importation
- the product is re-labelled or modified as required, within 3 months of being imported, for its lawful sale in Canada
In 2015, we implemented an ANI process pilot to promote compliance with the regulatory provisions. Through this compliance monitoring project, we wanted to verify how importers are complying with the ANI process pilot and the Regulations after they submit an advance notice of importation.
What we reviewed
We visited the facilities of 8 importers that have previously submitted ANI notifications to Health Canada between October 2019 and January 2020. At each visit, we reviewed the labels and advertising materials of products imported through the ANI process. We also verified that companies made the modifications and/or re-labelled the products within the 3-month deadline set out in section A.01.044(2) of the FDR, for its lawful sale in Canada.
We focused on 2 types of products:
- drugs requiring modification/re-labelling before being sold as cosmetics in Canada
- drugs with a valid Canadian market authorization DIN (drug identification number), DIN-HM (drug identification homeopathic medicine number) or NPN (natural product number) and require modification/re-labelling before being sold as drugs in Canada
We used several risk-based criteria to select the importers we visited. For example, we considered the number and type of products they imported. We also chose companies across Canada to ensure a proportional representation of importers.
We conducted visits in British Columbia, Ontario and Quebec. Inspectors provided a summary of findings to the company after each visit.
What we found
We found some areas where importers needed to improve their practices to meet the requirements of the ANI process and the Regulations. For example, we found instances where products had not been modified or re-labelled as per the notice of importation. We also found that importers did not always make the changes within the 3-month timeline after importation.
What enforcement actions we took
When we found compliance issues, we took action to protect the health and safety of the people in Canada (see Table 1). This included asking that certain products not be sold until they were brought into compliance.
All the companies have addressed the issues to our satisfaction.
| Establishment name | Province | Issues identified | Actions |
|---|---|---|---|
Blue Charmmy Trading Co Ltd |
BC |
|
This product had labelling issues that posed a risk to health. Upon our request, the importer stopped selling the product until it was modified/re-labelled appropriately. All issues have been resolved and no other actions were deemed necessary at the time. |
Cosmetica-Bio |
QC |
|
We informed the company of the issues we noted. We reviewed their response and found it to be adequate. No other actions were deemed necessary at the time based on the low level of risk to health. |
Esthetique Electrolyse Canada |
QC |
|
These products had labelling issues that posed a risk to health. Upon our request, the importer stopped selling 4 products until they were modified/re-labelled appropriately. All issues have been resolved and no other actions were deemed necessary at the time. |
EXOD International |
ON |
|
We informed the company of the issues we noted. We reviewed their response and found it to be adequate. No other actions were deemed necessary at the time based on the low level of risk to health. |
Naos Canada Inc. |
QC |
|
These products had labelling issues that posed a risk to health. Upon our request, the importer stopped selling 2 products until they were modified/relabelled appropriately. All issues have been resolved and no other actions were deemed necessary at the time. |
Pierre Fabre Dermo Cosmétique Canada |
QC |
|
These products had labelling issues that posed a risk to health. Upon our request, the importer stopped selling 4 products until they were modified/relabelled appropriately. All issues have been resolved and no other actions were deemed necessary at the time. |
Sopar International |
QC |
|
We informed the company of the issues we noted. We reviewed their response and found it to be adequate. No other actions were deemed necessary at the time based on the low level of risk to health. |
VDI Healthcare |
ON |
No findings |
Not applicable |
What will we do with the results
The compliance monitoring project allowed us to collect information on how importers complied with the ANI process pilot. Although we only visited a small number of importers, we used the results to provide additional guidance to industry on how to meet regulatory requirements.
We also used the results to evaluate the ANI process pilot and identify next steps. Moving forward, we will continue to inform the people of Canada on our proactive monitoring activities.
For more information
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