Oversight on the quality of active pharmaceutical ingredients for veterinary use in Canada
We are increasing the oversight on the quality of active pharmaceutical ingredients for veterinary use in Canada. This work supports human and animal health and food safety.
On this page
- Active pharmaceutical ingredients for veterinary use
- Rules for active pharmaceutical ingredients for veterinary use
- When these rules come into effect
- Who these rules apply to
- How to meet the rules
- Contact us
Active pharmaceutical ingredients for veterinary use
The active ingredient in a pharmaceutical drug is called an active pharmaceutical ingredient (API). Examples of APIs for veterinary use are ingredients such as corticosteroids or antibiotics found in ear drops to treat infection. The quality of APIs in a drug has a direct effect on the safety and efficacy of that drug.
Having appropriate controls over APIs for veterinary use helps increase the quality and safety of drugs for:
- the safety of the food supply
- consumers and their animals
For this reason, most countries around the world are regulating active pharmaceutical ingredients.
Rules for Active Pharmaceutical Ingredients for veterinary use
To increase oversight on APIs for veterinary use, we are implementing these regulatory requirements:
- APIs for veterinary use must be manufactured in accordance with Good Manufacturing Practices (GMP).
- Those who fabricate, import, package, label or test an API for veterinary use must hold a Drug Establishment Licence (DEL).
- Others who must hold a DEL are pharmacists, veterinarians or those compounding a drug under the supervision of a licensed veterinarian who imports for the purpose of compounding a medically important antimicrobial that is on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients.
When these rules come into effect
Good Manufacturing Practices
GMP requirements for all veterinary APIs come into effect May 17, 2018.
Drug Establishment Licences
There is a 14-month transition period ending July 17, 2019, in which you must submit a DEL application for these activities:
Those who do not have a DEL may continue to conduct activities until a decision is made on their DEL application. You may only conduct activities without a DEL if you submit an application before July 17, 2019.
Who these rules apply to
These rules apply to:
- including pharmacists or veterinarians importing an API on List A
- distributors, wholesalers and people who compound APIs under supervision
- agents and brokers of APIs are considered to be wholesalers
How to follow the rules
Good Manufacturing Practices
The GMP requirements for APIs used in drugs that are for people and animals are the same. These requirements are outlined in Part C Division 2 of the Food and Drugs Regulations (FDR).
GMP requirements apply to:
- quality control
- sterile products
- raw material testing
- manufacturing control
- finished product testing
- packaging material testing
GMP rules are specific to the activities you perform.
If you are an importer of APIs you will need to ensure you have evidence available to demonstrate compliance with GMPs. This applies to drugs fabricated, packaged/labelled, or tested outside of Canada.
There is more information on this in Health Canada's guidance on demonstrating foreign building compliance with drug good manufacturing practices.
Importing Active Pharmaceutical Ingredients for compounding veterinary drugs on List A
Healthcare professionals (veterinarians and pharmacists) who import APIs on List A need to comply with the same establishment licensing and GMP requirements as any other API importer.
The GMP requirements that apply when you import an API include having:
- appropriate oversight of API stability
- premises that are appropriate for storage
- maintenance of required records and labelling
- procedures to properly recall, manage complaints and ensure transportation and storage
- processes to ensure sourcing of APIs from GMP compliant sources, including requirements for written agreements with suppliers
- proper quality control oversight to ensure evidence of testing, such as ensuring copies of certificates of analysis are available prior to release for use or sale
- appropriate personnel to support importation activities (for example, sufficient number of staff that are qualified, trained and knowledgeable on requirements)
Drug Establishment Licence application process
A DEL is a licence issued to a person in Canada allowing them to conduct licensable activities with drugs. These activities occur in buildings found to be in compliance with the requirements of Divisions 2 to 4 of Part C of the FDR.
An application needs to be submitted before July 17th, 2019 for activities related to veterinary APIs to be allowed to continue. Within the application you must also send a cover letter indicating details of the importer and/ or other relevant facts.
Importers are also required to submit an application requesting the addition of a foreign site to their DEL if the foreign site is performing the fabrication, packaging, labelling or testing of finished dosage form drugs (FDFs), sterile APIs or the testing of non-sterile APIs before use in the fabrication of FDFs (release testing).
Applications to add the foreign sites described above must include GMP evidence.
A DEL application form must be completed with every application and include:
- a completed Table A
- applicant information
- Canadian building information
- foreign building information (if applicable)
Table A is used to list all foreign buildings conducting licensable activities related to APIs:
- imported into Canada and/or
- used in the fabrication, packaging/labelling and/or testing of finished dosage forms in a foreign country and intended for import into Canada
You can find more information in Health Canada's Guidance on Drug Establishment Licences and licensing fees. It is designed to help companies facilitate understanding and compliance with:
- Part C, Division 1A of the Food and Drug Regulations and
- the Fees in Respect of Drugs and Medical Devices Regulations with regards to DEL requirements and associated fees
Contact the Health Product Inspection and Licensing Division of Health Canada for questions on:
- good manufacturing practices at GMP_Questions_BPF@hc-sc.gc.ca
- drug establishment licensing at firstname.lastname@example.org
For more information
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