Notice: Submission Filing Recommendations for Veterinary Drugs - Good Manufacturing Practices and Drug Establishment Licences

2021-02-16

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

This Notice applies to:

• New Drug Submissions
• Abbreviated New Drug Submissions
• Submissions for Post-Notice of Compliance (NOC) changes

Before veterinary drugs are authorized for sale in Canada, the VDD reviews them to assess their safety, efficacy and quality. If a drug submission is found to be satisfactory following this review, a Notice of Compliance (NOC) is issued by the VDD. Furthermore, before a drug can be sold in Canada, any person conducting licensable activities must also hold a valid Drug Establishment Licence (DEL), which includes having demonstrated compliance with the GMP requirements outlined in the Food and Drug Regulations. GMP compliance ensures that veterinary drugs meet the quality standards appropriate to their intended use before they are sold.

Information about GMP compliance status at the time of submission filing can help demonstrate a manufacturer’s commitment to product quality. It also provides a higher level of assurance during the review process about the reliability and integrity of the data provided in the submission.

For these reasons, it is requested that sponsors submit to VDD certain information at the time of filing a drug submission. This approach resembles other regulatory jurisdictions that require confirmation of GMP compliance status at the time of filing a drug submission. Various types of information may be submitted depending on the type of activity, as listed below.

For all licensable activities related to:

• Drug product manufacturing (final dosage form)
• Drug substance (active pharmaceutical ingredient - API) sterilization, lyophilization for sterile drug substances, and
• Drug substance release testing where the test results are used to release the API for use in the fabrication of the drug product

Option 1:

• Verification of existing Canadian GMP compliance status for all buildings performing any licensable activities, via:
  • Reference to a valid applicable DEL, or
  • Reference number(s) for the applicable site(s) found in Health Canada's Drug and Health Products Inspections Database

OR

Option 2:

• A GMP screening acceptance notice (i.e. at “Day 90”) from the Regulatory Operations and Enforcement Branch (ROEB), providing confirmation that a new DEL application or a DEL amendment (i.e. for new buildings and activities not currently listed on the applicable DEL) has been filed and accepted for review.

For all activities related to a drug substance (API) not captured above:

Option 1:

• Verification of existing Canadian GMP compliance status for all buildings performing any licensable activities for the drug substance, via:
  • Reference to a valid applicable DEL, or
  • Reference number(s) for the applicable site(s) found in Health Canada's Drug and Health Products Inspections Database

OR

Option 2:

• A GMP acknowledgement of receipt notice from ROEB, providing confirmation that a new application or a Table A DEL amendment has been filed. Table A is used to list all foreign buildings conducting licensable activities with regards to APIs and must be submitted with any DEL amendment application as part of the Drug Establishment Licence Form (FRM-0033).

OR

Option 3:

• In the case where a new application or a Table A DEL amendment cannot yet be filed, a summary of the status of the API site’s GMP information and plans for filing applicable information to ROEB.

Unavailable Information

If a foreign sponsor of a drug submission has buildings not yet listed in Health Canada's Drug and Health Products Inspections Database, and a Canadian importer has not yet been identified or filed a DEL application, then this scenario, along with plans for pursuing GMP compliance, should be clearly detailed in the submission.

Implementation Period

This Notice will come into effect for drug submissions filed after the date of this Notice.

Contact Information:

Health Products and Food Branch
Veterinary Drugs Directorate
Submission and Knowledge Management Division
Health Canada
Email: hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca

Regulatory Operations and Enforcement Branch
Health Product Compliance Directorate
Health Product Inspection and Licensing Division
Health Canada
E-mail: hc.del.questions-leppp.sc@canada.ca