New COVID-19 hold feature for certain drug establishment licence applications
Drug Establishment Licensing Bulletin 99, November 23, 2020
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About the COVID hold feature
The COVID-19 pandemic continues to have a significant impact on business operations. For example, the pandemic has impacted the ability of certain drug establishment licence (DEL) applicants to host a good manufacturing practices (GMP) inspection. This can affect timelines set under the 2019 fee regime.
The fees for drugs and medical devices were revised on April 1, 2020. Since then, Health Canada has been monitoring the 250-day service standard "clock" for issuing DELs.
If a GMP inspection that's required as part of a DEL application cannot take place as planned, there are limited options under the regime to accommodate delays. To account for the unforeseen delays brought on by the pandemic, Health Canada is implementing an interim "COVID hold". This feature will provide flexibility and offer the following benefits:
- give establishments impacted by the pandemic a chance to have their DEL application put on hold, securing their place in the application queue until a GMP inspection can be conducted
- avoid the need to withdraw DEL applications while resolving issues caused by the pandemic (for example, no need for affected applicants to re-apply for a DEL)
During this interim measure, the health and safety of DEL employees and Health Canada inspectors continues to be a priority. Public health guidelines and restrictions will continue to be in place to limit the spread of COVID-19.
The COVID hold feature will be applied when GMP inspections cannot be conducted due to either of the following reasons:
- pandemic's impact on a drug establishment's readiness for a GMP inspection (for example, reduced staff, closure, inability to receive or set up necessary equipment) or
- inability of inspectors to conduct a GMP inspection while respecting public health guidelines and restrictions in place due to the fluctuating COVID-19 situation in each region of the country
Foreign sites
Given the current public health guidelines and travel restrictions, Health Canada has postponed foreign on-site GMP inspections until further notice. Thus, this interim COVID hold feature will not apply for foreign sites.
However, DEL bulletins 75 and 84 outline flexibilities to the requirements for GMP evidence for DEL holders/applicants. The flexibilities include:
- extending the New Evidence Required BY (NERBY) dates for foreign building evidence
- extending the "age" of inspection reports to demonstrate GMP compliance of foreign buildings (from 3 years to 5 years)
- considering corporate or consultant audits
Time limit
The interim COVID hold feature applies to new DEL applications and amendments to existing DELs. Health Canada will notify applicants whose applications have been put on COVID hold.
There is no time limit for COVID holds placed on a DEL application while the pandemic lasts.
Contact us
You may provide your feedback by sending an email to us at hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca.