Consultation on the Proposed Teat Antiseptic Product Monograph

From Health Canada

Why

Teat antiseptic products are widely used by dairy farmers to help reduce the spread of organisms which may cause mastitis in dairy cattle.

The proposed monograph will provide a tool for efficient regulatory review of teat antiseptic products with well-known safety and efficacy profiles under specific conditions of use. It will also allow a uniform regulatory approach to teat antiseptic products.

Who

We are looking for comments from:

• stakeholders, such as:
  • drug manufacturers
  • importers and distributors
  • veterinarians, food animal producers and their associations
• all others who have an interest, such as:
  • dairy farmers
  • consumers

What

Health Canada currently regulates teat antiseptic products under the Food and Drug Regulations including Division 1 (not new drugs) and Division 8 (new drugs).

The proposed Monograph outlines the specific conditions of use and labelling as well as regulatory requirements to receive market authorization for a teat antiseptic product.

With this proposal, a product and its labelling that is:

• consistent with the information in the monograph, may be considered as a not new drug under Division 1
• outside of the scope of the monograph, may be considered as a new drug under Division 8

When and where

The consultation will be available at canada.ca/health for 8 weeks, from March 6, 2017 to May 6, 2017.

How to participate

You are encouraged to read the Teat Antiseptic Product Monograph consultation document.

Email your comments to: consultationvdd-dmv@hc-sc.gc.ca.

Next Steps

Your comments will be reviewed and considered for inclusion in the Monograph.

Related information

• Food and Drugs Act
• Food and Drug Regulations

Contact us

Mailing address:
Veterinary Drugs Directorate
Health Canada, Health Products and Foods Branch
Holland Cross Complex
14-11 Holland Avenue
Ground Floor
Ottawa, ON K1A 0K9

Email: consultationvdd-dmv@hc-sc.gc.ca