Deficiencies: Applications and service standards for drug establishment licences (GUI-0127)

Health Canada issues a “deficiency notice” when it cannot process an application for 1 of the following reasons:

• application does not meet the requirements of the Food and Drug Regulations
• intent or scope of the application is not clear or
• drug establishment licence application form (FRM-0033) is missing required information for Health Canada to determine the stream

Examples of deficiencies include the following:

• a version of FRM-0033 other than the most recent version was submitted
• FRM-0033 is incomplete and does not include all required sections and documents
  • for example, an application requests that activities be added to a foreign building for a category or dosage form of drug that the domestic building is not licensed to import and there has been no request made to add import for the category or dosage form 
• the required active pharmaceutical ingredient (API) information is not included in the application (Table A)
• the application lists a dosage form that is not currently on the approved list of dosage forms found in the Drug Product Database
• the application does not include good manufacturing practices (GMP) evidence that meets the requirements in How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080), such as:
  • lack of evidence (including when the foreign building is sending the evidence on the importer’s behalf)
  • missing dates, signatures or required documents
  • evidence is heavily redacted and Health Canada cannot make its own conclusions about GMP compliance
  • the foreign building inspection was not conducted using GMP standards outlined in Good manufacturing practices guide for drug products (GUI-0001)
  • more recent evidence is available for the foreign building than what was provided at the time of submission
  • supporting GMP evidence does not cover the requested activities, categories or dosage forms
  • the foreign building name or address listed on FRM-0033 does not match the address on the site master file (SMF) or certificate of compliance (CoC)
  • A CoC or extra-jurisdictional CoC that was selected as supporting evidence is not available or does not cover the requested activities, categories or dosage forms