Exceptional importation and sale of drugs in relation to COVID-19:  For industry

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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

To add a drug in a Tier 3 shortage to the List of Drugs for Exceptional Importation and Sale, please fill out proposal form and email it to hc.ds-iopropau-pm.sc@canada.ca.

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:

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:

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:

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 hc.ds-ionotifau-pm.sc@canada.ca. The email must contain the following information:

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 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:

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.

Keeping records

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:

However, this information must be made available to Health Canada upon request.

Written agreements

Canadian importers should ensure they have access to written agreements when importing designated drugs.

Release process

Canadian importers can base the release of a designated drug on:

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.

Biocides

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 hc.covid19healthproducts-produitsdesante.sc@canada.ca.

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.

Contact us

To add a drug to the List, submit proposals to hc.ds-iopropau-pm.sc@canada.ca.

To import designated drugs, submit notifications to hc.ds-ionotifau-pm.sc@canada.ca.

To import biocides, contact hc.covid19healthproducts-produitsdesante.sc@canada.ca.

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