ARCHIVED - Measures to reduce the impact of COVID-19 on your business and operations

Drug Establishment Licensing Bulletin 84, April 16, 2020

On this page

• New measures to help DEL holders
• How to reduce the impact on your business
• Additional measures to provide relief
• Contact us

New measures to help DEL holders

Health Canada recognizes that the COVID-19 pandemic has had a significant impact on your business operations.

We have introduced measures that provide regulatory and operational flexibilities to regulated parties. These measures place a focus on critical services for medically necessary drugs and those drugs that are important in mitigating the risks of COVID-19. (Our DEL bulletins issued in March 2020 contain information on these measures. To access all of our bulletins, you may ask to access our blog on the GC Collab platform by sending an email to DEL.Questions-LEPPP@hc-sc.gc.ca.)

As the situation evolves, we will continue to identify and communicate additional regulatory and operational flexibilities. Our goals are to:

• mitigate impacts to your business
• assure there's appropriate product quality oversight
• ensure people in Canada can access the drug products they need quickly

How to reduce the impact on your business

Many patients in Canada and around the world rely on continued access to the drugs produced and supplied through Canadian drug establishment licence (DEL) holders.

In this unprecedented time, you may encounter a number of challenges, such as:

• limited availability of staff, which restricts the work that can be performed
• disruptions in material supplies, drug supplies and distribution chains
• limited availability of contract service providers (for example, external calibration services, specialized equipment maintenance providers)

You may need to make interim adjustments in the way you operate. When doing so, make sure that you continue to comply with good manufacturing practices (GMP). Be sure also to follow good quality risk management (QRM) principles that consider the best interests of patients.

Examples of changes that you may consider:

• adjusting equipment calibration, requalification or maintenance frequencies
• revising approaches to vendor audits or requalification (for example, deferring on-site audits with interim desktop approaches)
• deferring periodic confirmatory testing for raw materials or imported drugs
• deferring ongoing periodic training
• deferring annual product quality reviews

These are just some examples. They may not be appropriate for every situation. For example, deferring equipment calibration or maintenance may not be appropriate if these increase the risk of failure based on your equipment history.

Use your judgment.

For more information about QRM, please consult Health Canada's:

• Good manufacturing practices guide for drug products (GUI-0001)
• Good manufacturing practices (GMP) guidelines for active pharmaceutical ingredients (API)

You may also wish to consult the International Council for Harmonisation's guidance document on Q9: Quality Risk Management .

Risk mitigation options are also available within GMP. For example, drug fabricators may decide to validate a process concurrently (release batches on their own merit before completing the full study). Our Guide to validation for drugs and supporting activities (GUI-0029) indicates when concurrent validation is allowed. Fabricators may decide to use this approach based on appropriate assessment and justification under QRM.

Also consider any impacts on a product's market authorization when determining what adjustments to make to your pharmaceutical quality system. Unless otherwise indicated in a notice or interim order, the requirements of the Food and Drugs Act, Food and Drug Regulations and applicable guidance remain in effect.

You can find more information in the following guidance document:

• Post-notice of compliance (NOC) changes: Quality document

Also ensure you are reporting drug shortages . This helps us build a more open and secure drug supply system for people living in Canada.

Additional measures to provide relief

Foreign building evidence

To provide operational relief during this pandemic, effective immediately and until further notice, Health Canada is offering the following measures to regulated parties for foreign building requests:

• extending the new evidence required by (NERBY) date for all foreign buildings until further notice
  • note that if you have full evidence as per GUI-0080, you may still submit the evidence to us at any time before the existing NERBY on your DEL
• allowing applicants to submit an inspection report that was issued in the last 5 years to demonstrate compliance of a foreign building
• allowing applicants to submit a corporate/consultant audit report to demonstrate GMP compliance of foreign buildings for all activities/ product types
  • use the Good manufacturing practices - audit report form (FRM-0211) to ensure that all applicable Canadian GMP requirements are assessed
• allowing GMP evidence that's older than 3 years
  • the inspection must be conducted against Canadian GMP standards, or ICHQ7, with no risks to health and safety identified

DEL applications

When submitting your DEL applications for medically necessary drugs or drugs that are important for mitigating COVID-19 risks, remember to include the term "COVID-19" or "medically necessary" in the subject line of your email. Please limit the scope of your application to those products only.

To help us prioritize your application, include the following information in your DEL application cover letter:

• drug's brand name
• drug identification number (DIN)
• drug's active ingredient(s)

If you already have a DEL application for a medically necessary drug or a drug that's important to mitigate COVID-19 risks, and you have not identified it as such, please send an email to hc.del.alr-eal.lepp.sc@canada.ca with the following information:

• application number
• drug's brand name
• DIN
• drug's active ingredient(s)

In the email, confirm whether the application is exclusively for that drug. If it isn't, specify what portion of the application relates to that drug (for example, which foreign building, activities).

Contact us

• drug establishment licensing: hc.del.questions-leppp.sc@canada.ca
• domestic GMP inspections: hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca
• foreign GMP inspections: hc.foreign.site-etranger.sc@canada.ca