By: Teri Jenner, Manager, Regulatory Affairs Group, email
Product Monographs are documents containing pre-cleared information that describe the properties, claims, indications and conditions of use of a product. They also contain other information that may be necessary for the optimal, safe and effective use of the product.
When filing to receive market authorization (Natural Product Number (NPN) or Drug Identification Number (DIN)) following a product monograph allows for a simpler submission and an expedited review time.
Health Canada has updated its monograph for Antiseptic Skin Cleansers (Personal Domestic Use) and there are a couple changes which should be noted:
- Required label wording has changed;
- The former cosmetic claim “antibacterial cleanser” will now require registration
A complete list of Pre-Cleared Information and Products monographs can be found here.