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Health Canada Notice - Revisions of DEL Guidance Documents and Forms as a Result of Amendments to the FDR

May 22, 2018

DEL Bulletin #25: Important Notice to Stakeholders Regarding Revisions of Drug Establishment Licensing Guidance Documents and Forms as a Result of Amendments to the Food and Drug Regulations

Pursuant to several amendments to the Food and Drug Regulations (FDR) which impact Drug Establishment Licensing, GUI-0002: Guidance on Drug Establishment Licences and Drug Establishment Fees has been revised to reflect the changes. The revised guidance document is attached to this bulletin; the new Guide will be posted on line in the coming weeks.

Additionally, the revised GUI-0002 will replace the Frequently Asked Questions – Drug Establishment Licensing and Fees as this information is now more accurately reflected in the guide. Information regarding changes to Drug Establishment Licensing requirements and documents can be found below:

1. Vanessa’s Law

Vanessa’s Law received royal assent on November 6, 2014, and amended the Act to enable Health Canada to regulate a drug more efficiently and effectively throughout its life cycle, beginning with the pre-market application for an authorization to sell the drug, to post-market follow-up when the drug is made available to Canadians. The Food and Drug Regulations related to the suspension of DELs were also amended (C.01A.016-C.01A.018 of the FDR). For more information on the DEL Compliance and Enforcement strategy, including the Suspension Authority as a result of Vanessa’s Law, please consult the revised GUI-0002.

2. DINs for Schedule C Drugs

As per the amended regulations posted in the Canada Gazette II which will come into force on June 13, 2018, drugs listed on Schedule C to the Food and Drugs Act (FDA) will require a DIN to be sold in Canada. Amendments have been made to Division 1A of the Food and Drug Regulations (FDR). Namely, revisions were made to align the Drug Establishment Licence (DEL) distribution requirements with the new Schedule C DIN requirements. A DEL with the activity of distribution continues to be required to distribute finished dosage form Schedule C drugs in Canada. Additional amendments were made to clarify regulations surrounding the active ingredients used in the fabrication of drugs of non-biological origin that are listed in Schedule C to the FDA. These active ingredients are subject to the same DEL requirements as active pharmaceutical ingredients. For more information on the DEL requirements for radiopharmaceuticals, please consult GUI-0002.

Veterinary Drugs – Antimicrobial Resistance

1. Drug Establishment Licensing and Good Manufacturing Practices Requirements

Regulatory changes to the FDR were published in the Canada Gazette, Part II and have come into force on May 17, 2018. There is a 14-month transition period ending July 17, 2019 to submit a Drug Establishment Licence (DEL) application for those who fabricate, package/label, test or import active pharmaceutical ingredients (APIs) for veterinary use.  These will be required to comply with Good Manufacturing Practices (GMP) for human APIs (GUI-0104) is to be applied to veterinary APIs. It is important to note that pharmacists, veterinarians or those compounding a drug under the supervision of a licensed veterinarian are also expected to hold a DEL when importing medically important antimicrobials that are on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients. In order to facilitate the implementation of the amended regulations, updates have been made to the forms that are used to submit Drug Establishment Licence applications: 

In order to facilitate the processing of applications related to AMR, please ensure that application packages include the following:

  • A cover letter which clearly indicates whether or not you have been conducting licensable activities related to active ingredients for veterinary use on or before May 17, 2018
  • A completed Section 3.1: Domestic Active Pharmaceutical Ingredient (API) Information of FRM-0033
  • A completed Section 5.1: Active Pharmaceutical Ingredient Foreign Building Information
  • A completed Table A: Foreign Buildings Conducting API-Related Licensable Activities
  • If you have already submitted an application related to AMR and have not provided the information mentioned above, please send an email to hc.el.applications-le.sc@canada.ca indicating your application number and any missing information

2. Atypical active pharmaceutical ingredients

  • Health Canada is notifying stakeholders of an interim approach concerning the implementation of Establishment Licensing requirements for certain APIs for veterinary use that are of lower risk and widely used outside of the pharmaceutical industry.
  • These APIs, considered as atypical APIs for the purpose of this notice, are currently used as pharmaceutical excipients, or as ingredients in natural health products (NHPs), veterinary health products (VHPs), as well as foods and meet recognised standards other than GMPs. They are as follows:
    • The atypical API list for human use is being expanded to include veterinary use.
    • The following additional APIs for veterinary use only:
      • Biotin (Vitamin B7)
      • Calcium iodate
      • Calcium Propionate
      • Chlorhexidine acetate
      • Choline bitartrate
      • Cobalt carbonate
      • Cobalt gluconate
      • Copper gluconate 
      • Copper oxide
      • Dexpanthenol (panthotenic acid, B family)
      • Dipiperazine sulfate/piperazine
      • Hydrogen peroxide
      • Inositol
      • Iodine (topical)
      • Linear dodecyl benzene sulfonic acid
      • Manganese sulphate
      • Menadione sodium bisulfite
      • Niacinamide (Vit B3)
      • Poloxalene
      • Potassium iodide
      • Pyrridoxine HCl (Vitamin B6)
      • Riboflavin (as 5-sodiumphosphate) Vit B2
      • Salicylic acid (topical products for vet use)
      • Sodium chlorite
      • Sodium iodide
      • Sodium linear alkylate sulfonate
      • Sodium propionate
      • Sodium selenite
      • Thiamine HCl
  • Importers of the above listed atypical APIs and finished dosage form importers of products formulated using these atypical APIs, who are not able to obtain appropriate GMP evidence, can complete the Table A and FRM-0033 in accordance with the following instructions:
  1. Column L - Indicate 'Exception' and include the standard that the API is manufactured against (e.g. 'Exception - ISO' or 'Exception - HACCP').
  2. Columns M, N, O and P can be indicated as "Exception".
  3. All other columns should be filled out as per regular Table A instructions.
  • It is important to note that each lot or batch of the atypical API shall, prior to its availability for sale, be tested against and comply with the specifications for that API.  In cases where there is a pharmacopoeial standard (Schedule B to the Food and Drugs Act) for the atypical API, the API should be manufactured and tested against that standard.
  • Importers continue to be responsible for having written agreements with foreign buildings and evidence of the foreign building’s compliance to the quality standard indicated. Furthermore, the dosage form fabricator, the DIN-holder and the dosage form importer are responsible to assure the acceptable quality and safety by meeting all applicable requirements of Part C, Division 2 of the Food and Drug Regulations, including Raw Material Testing sections C.02.009 and C.02.010.  Should a risk to health be identified, Health Canada will take appropriate compliance and enforcement action proportional to the risk.
  • This approach will remain in place until Health Canada notifies stakeholders otherwise. A formal consultation process will be launched shortly for the atypical API list for veterinary use.