Currently, such products are regulated under the Medicines Act 1981, which requires them to be approved before being allowed on to retail shelves, often translating into higher costs and a slower time-to-market.
Approval must be granted for both new products and changes to existing products, such as new flavors or colors, whereby suppliers are required to submit an application and pay a regulatory fee.
However, in most other countries, many fluoride toothpastes and anti-dandruff shampoos do not require pre-market approval as they are treated as cosmetics rather than medicinal products.
Regulatory changes would scrap pre-market approval
The Ministry of Health is proposing that oral care products with less that 0.15 percent fluoride content and anti-dandruff shampoos designed to treat only dandruff should be excluded from regulation under the Act.
“The changes would mean that the sorts of toothpastes and anti-dandruff products commonly sold in supermarkets would no longer be regulated under medicines legislation,” principal advisor of regulation, Susan Martindale said in a statement.
The planned amendments are intended to improve efficiency, remove barriers to innovation and achieve better alignment between the law and modern practice, according to Martindale.
In addition to reducing regulatory and compliance costs for suppliers, which may result in a wider range of products being marketed in New Zealand, the Ministry said in a statement, time-to-market for such products will also be reduced.
“[The changes] would bring New Zealand into line with many other countries including Australia,” saidMartindale.
Some products to remain regulated under Medicines Act
According to the Ministry of Health, although the proposed changes will affect most fluoride toothpastes and anti-dandruff shampoos sold via supermarket and general retail channels, not all products will be exempt from regulations.
Oral care products that will continue to be regulated under the Medicines Act will include toothpastes with high levels of fluoride, or other substances used to treat teeth sensitivity.
Hair care products still requiring pre-market approval will include anti-dandruff products that can only be sold through pharmacies, and those that are intended to treat conditions such as psoriasis of the scalp as well as dandruff.
The Ministry is accepting submissions on the proposal until March 25, and says the amended regulations could come into effect in late 2010.