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REGULATORY INFORMATION

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Guidelines & Codes

Update to Section 10.1B New and Changed Related Products - Dentifrices
[NZRGM, Volume 1, 5th edition]

Added to web site: September 2003

Fluoride Classification change

As a result of recent classification changes, most fluoride containing mouthwashes have been reclassified from Related Product to Pharmacy Only Medicine. This change means that these products no longer meet the criteria to be evaluated as Related Products.

Medsafe will work with those companies whose applications are currently in process as New Related Product Applications.
All new applications for these products will be required to be submitted as New Medicine Applications and will need to provide the appropriate supporting documentation.