Interim drug product testing measures for licensed importers

Drug Establishment Licensing Bulletin 76, March 23, 2020

On this page

• About the new interim drug testing measures
• The details

About the new interim drug testing measures

Health Canada continues to work closely with the Public Health Agency of Canada, which is leading the COVID-19 public health response and pandemic planning. We are also working with provincial, territorial and international partners to monitor and respond to this evolving situation.

It’s critical that we take additional steps at this time to ensure Canadians have continued access to the medications they need. As such, we are introducing new interim approaches to prevent delays in the release of drug products being imported into Canada from countries that do not have mutual recognition agreements (MRA).

The measures will also ensure that medications sold in Canada meet safety, quality and efficacy requirements.

The details

Effective immediately and until further notice, all importers of drugs licensed under Division 1A of the Food and Drug Regulations (FDR) may:

• apply expanded use of unique identifiers in order to confirm identity based on physical verification
• ship a product from the fabricator to Canada in quarantine
• defer confirmatory testing when required

Apply expanded use of unique identifiers to allow for confirmation of identity based on physical verification

When laboratory testing is required for identification purposes but is not readily available, companies may modify their approach to confirm the identity of the drugs being imported. Companies may, for example:

• visually inspect the labelling on samples of a product taken from each batch received against approved product labelling
• visually compare the drug in dosage form against that of previously retained samples or other comparative information
• physically measure (for example, dimensions, volume) a sample of the drug in dosage form

Canadian importers will still be required to meet all product release requirements, which are in section C.02.014 (quality control department) of the FDR. For the applicable interpretations, please consult the guidance document Good manufacturing practices guide for drug products (GUI-0001).

Canadian importers must be able to trace the entire supply and transportation chain right from the drug manufacturer. Thus, all companies conducting licensable activities for a product being released must have a drug establishment licence (DEL) or be listed on the foreign site annex of the importer’s DEL.

Receive allowance for shipping a product from the fabricator to Canada in quarantine

Health Canada is aware of the challenges associated with transporting drugs from other jurisdictions into Canada. Thus, we will not object to a product being shipped to Canada before testing is completed and the product is shipped in quarantine.

However, Canadian importers are still expected to:

• have appropriate systems to quarantine all such incoming shipments until they are released
  • the quarantine system must effectively prevent the accidental shipment or release of the product
• ensure all required testing is completed before the product is released to the Canadian market
• assess the product per all release requirements, including reviewing all testing certificates of analysis

Defer confirmatory testing when required

Importers have expressed concerns about being able to meet confirmatory testing requirements. If companies are not able to conduct such tests, confirmatory testing requirements may be deferred.

Note: As per the requirements in the GUI-0001 guidance document, a product may be released for sale before confirmatory testing is completed, provided all other product release requirements are met.

All products must comply with Canadian regulations and marketing authorizations. Thus, Canadian importers are expected to apply the appropriate oversight of their supplier and manage any identified risks. This includes reviewing the supplier’s history to demonstrate they can consistently supply a product that meets Health Canada’s requirements.

Health Canada recognizes that companies may experience challenges due to the COVID-19 pandemic. Responses to these challenges should be based on documented quality risk assessments and/or in accordance with your company’s pharmaceutical quality system requirements.

For further clarification on this interim approach, please email us at hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca.