Exceptional importation and sale of drugs in relation to COVID-19: For industry
On this page
- How to propose an addition to the list of designated drugs
- How to import and sell designated drugs
- Regulatory requirements for selling designated drugs
- Interim Order changes to GMP requirements for Canadian importers
- Contact us
How to propose an addition to the list of designated drugs
The following actions must be taken to propose an addition to the list of designated drugs.
Step 1: Submit proposal
Health Canada will assess the proposal and may contact you to clarify information or to ask for product-specific information. Our review depends on a number of factors, including but not limited to product type and availability of supply.
Of note, Canadian importers are expected to provide a risk communications plan in their proposal that outlines how they intend to ensure accessibility of information that supports safe use of the drug. Importers are expected to take steps to ensure information is accessible in both official languages.
Note: We may also add a product to the list without receiving a proposal.
Step 2: Ensure compliance
Health Canada must have evidence that foreign buildings which fabricate, package/label and test designated drugs and their active pharmaceutical ingredients (API) are GMP compliant for the applicable activity, category of drugs and dosage form.
Health Canada expects that, in many cases, designated drugs will be sourced from foreign buildings that are already listed on the:
- Foreign Building Annex of the Canadian importer’s DEL (with the applicable activity, category of drugs and dosage form), and
- the API annex.
For these cases, there will be no need for additional foreign building compliance information, unless requested by Health Canada.
In cases where the foreign buildings are not currently listed on the Foreign Building Annexe of the Canadian importer’s DEL, Health Canada will clearly communicate foreign building compliance evidence and documentation requirements.
A foreign building will be considered compliant if:
- It is currently determined to be compliant by Health Canada
- It is currently determined to be compliant by a trusted regulatory partner for the applicable activity, category of drugs and dosage form.
Other examples of foreign building compliance may be accepted on a case-by-case basis. Health Canada will expedite the approval process to amend the DEL.
How to import and sell designated drugs
Step 1: Approval to import and sell designated drugs
Canadian importers will be permitted to import and sell designated drugs once:
- the drug is on the List of Drugs for Exceptional Importation and Sale
- their DEL Foreign Building Annex and API building annex have been amended as required
Although the Canadian importer is permitted to sell designated drugs once included on the list of designated drugs, they must still notify Health Canada when designated drugs are imported.
Step 2: Pre-importation notification requirements
Importers must notify Health Canada at least 5 calendar days before the day they import a designated drug. They must do so by sending an email to email@example.com. The email must contain the following information:
- importer’s name and contact information
- name, address and contact information of each fabricator, packager/labeller and tester involved with the drug
- brand name of the drug to be imported
- medicinal ingredient(s)
- dosage form
- route of administration
- identifying code
- detailed description of the conditions of use of the drug
- intended port of entry into Canada
- intended date of arrival into Canada
- customs identification number for the shipment
- total quantity of drug to be imported
Step 3: Information to Support Safe Use Requirements
Under section 10 of the Interim Order, Canadian importers are required to ensure information is available in a manner that supports safe use of the drug, which includes taking steps to ensure information is accessible in both official languages. Canadian importers are expected to work closely with Health Canada on the review and implementation of a risk communications plan to ensure compliance with this requirement.
Regulatory requirements for selling designated drugs
During the application of the interim order, Canadian importers may bring designated drugs into the country without meeting all the requirements of the Food and Drug Regulations (FDR). However, Health Canada wishes to highlight the following:
- Importers are still obligated to report all adverse drug reactions (C.01.016 to C.01.019).
- Hospitals/Medical Professionals must continue to report serious adverse drug reactions (C.01.020.1).
- Existing requirements and controls for prescription drugs will remain in effect (C.01.040.3 to C.01.049).
- Importers must report all recalls (C.01.051).
- Importers must adhere to all DEL requirements in Division 1A of the FDR, including listing foreign buildings on their licence (this includes considerations applicable for the active pharmaceutical ingredient (API), intermediates, and finished dosage forms).
- Importers must fulfill most good manufacturing practices (GMP) requirements, as outlined in Division 2 of the FDR, with some exceptions (see the next section).
Importers should note the exemptions to certain sections in Part A of the FDR, as indicated in the interim order, along with the requirements that remain in effect including:
- Obligations for security packaging when the drug is intended for sale to the general public (A.01.065)
- Provisions relating to advertising (A.01.067) and sale (A.01.068)
Interim Order changes to GMP requirements for Canadian importers
Canadian importers of designated drugs must follow the same GMP requirements that apply to all imported drugs. The interim order (IO) provides some exceptions.
Importers do not need to maintain records specified in Section C.02.020 (1) parts a, b and d of the Food and Drug Regulations at the importer’s building address in Canada, such as:
- master production documents
- validation reports
- executed batch records
- stability documentation
However, this information must be made available to Health Canada upon request.
Canadian importers should ensure they have access to written agreements when importing designated drugs.
Canadian importers can base the release of a designated drug on:
- Certificates of Analysis and Certificates of Manufacture (or equivalent) from buildings listed on the DEL foreign building annex. All release testing must be completed prior to release of product.
- Confirmation that the drug has been transported and stored properly.
- Visual inspection of the drug to confirm its identity. Visual inspection should include:
- product labelling
- dosage form
- physical measurements (for example, dimensions, volume), if applicable
Release documentation should clearly indicate that the drug was released under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19.
For DIN applications and new drug submissions for eligible biocides under the IO, we do not require mock-ups of labels or package inserts. However, we do require the full text of labels and inserts. These are modifications of sections C.01.014(2)(m) and (m.1), C.08.002(2)(j) and (j.1) of the Regulations under the IO.
No DEL is required to import or sell DIN hand sanitizers or hard surface disinfectants. To import and sell a biocide or natural health product hand sanitizer under the interim measure implemented on March 18th, 2020, email firstname.lastname@example.org.
Note: Importers are responsible for ensuring they meet all applicable GMP requirements. All importations and sales must also meet Division 2 requirements under the Regulations.
To add a drug to the List, submit proposals to email@example.com.
To import designated drugs, submit notifications to firstname.lastname@example.org.
To import biocides, contact email@example.com.
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