End of DEL transition period for Hand Sanitizers

End of DEL transition period for Hand Sanitizers

In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested by the World Health Organization (WHO) to fight and stay safe from COVID-19. Adaptation of effective hand hygiene is vital, as advised by WHO to wash or sanitize your hands frequently with soap or >60% alcoholic hand sanitiser, respectively. The recommendation is based on fast, effective, and broad-spectrum antimicrobial activity combined with easy availability and considered safe. It is therefore not surprising to see the demand for hand sanitiser go threw the roof immediately after the preventive declaration was made. 

In Canada, Health Canada responded with an interim and expedited licencing approach for the production of and distribution of alcohol-based hand sanitisers to facilitate increased access to safe and effective hand sanitizers. The interim measure simplifies the application process and prioritizes the review process for both site licenses (Drug Establishment Licence, DEL) and product licenses. 

Given the interim nature of the DEL issued under this interim measure, certain GMP requirements for natural health products (NHPs) were waived during this period. Specifically, stability testing was not required; a quality assurance report or other forms of evidence required as part of the standard process was not required; and for products containing more than 50% alcohol, finished product testing for microbiological contaminants was not required. Many other stringent GMP requirements for safety and efficacy were however retained to ensure the production of safe and effective hand sanitizers.

Consolidating on the interim order and as the demand for alcohol-based hand sanitizers stabilized, Health Canada through the Natural and Non-Prescription Health Products Directorate (NNHPD) announced in March 2021 the intention to bring an end to the Covid-19 interim order. Specifically, Health Canada set forth to end the temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers on September 30, 2021. It therefore meant Health Canada was lifting flexibilities for drug establishment licences (DELs) under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Furthermore, a DEL will now be required to conduct licensable activities for designated hand sanitizers (fabricate, package/label, test, import, or distribute) and a six-month transition period was provided to allow interim SL holders to apply for a valid DEL to continue producing hand sanitizer. Otherwise, an interim SL holder is required to stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.

Considering that the Drug Establishment Licence (DEL) transition period for designated hand sanitizers ended on September 1, 2021, companies that failed to apply for a DEL (or to amend a DEL) must cease all licensable activities related to designated hand sanitizers that were authorized under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. However, if you would like to continue manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers, you need to apply for a new DEL and wait for approval to conduct these licensable activities. Contact Quality Smart Solutions for assistance!

References

Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html

World Health Organization, 2020. WHO guidelines on hand hygiene in health care: first global patient safety challenge clean care is safer care. Geneva: the Organization [cited 2020 Apr 08]

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