What We Heard - proposed Teat Antiseptic Product Monograph
Overview of engagement process
In response to the consultation on the proposed Teat Antiseptic Product Monograph from March 6, 2017 to May 6, 2017, Health Canada received almost 50 responses from stakeholders. The monograph describes the requirements necessary to receive market authorization for antiseptic teat solution products. Comments were received from stakeholders in various sectors, including veterinary drug manufacturers, importers, distributors, dairy farmers and their associations. The purpose of this report is to provide a summary of the comments received. The final monograph is posted here.
Summary of feedback received
What did the stakeholders say?
There was overall support for the proposed monograph. However, some suggestions to improve clarity and flexibility were provided, for example:
- provide more description of data requirements
- include definitions of terms
- add flexibility with respect to ingredient strengths, ranges and combinations
- provide more clarification on the scope of the monograph, i.e. applicable to teat solution products only
- add flexibility for product labelling, i.e. allow label reference to product compatibility with certain Automated Milking Systems (AMS) and/or other methods of application.
How was the feedback taken into consideration?
- The scope of the monograph was clarified by changing the title to "Antiseptic Teat Solutions Monograph". Udder wash solutions and teat/udder wipes are excluded.
- For greater clarification on data requirements and terminology, the following additions were made to the monograph:
- a list of pharmaceutical quality requirements that manufacturers are expected to have available upon request
- a glossary.
- Alternative label terminology may be considered provided that the terms and/or statements used are consistent with those listed in the monograph.
- The monograph is not intended to evaluate the compatibility of AMS (or other methods of application) with various teat solution products and thus no such label reference is permitted. Label statements regarding product application should only refer to the complete coverage of all teats with the solution.
- Some ingredient strengths, ranges and/or combinations were revised where permitted (i.e. as long as formulations remain consistent with those of currently approved products with well-known safety and efficacy profiles).
Next steps – how to file a submission or product classification request
We have addressed the feedback and incorporated suggestions to inform the final Antiseptic Teat Solutions Monograph.
Please follow the instructions in the foreword of the monograph if you wish to file a submission, and send to hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca.
To confirm whether a product falls within the scope of the monograph, please contact hc.classification.vet.sc@canada.ca for a product classification request.