Te Puna Ora o Mataatua has just made its submission to the Therapeutic Products Bill.
The bill seeks to provide for the regulation of therapeutic products in a comprehensive way that balances the risks and benefits of the products.
Therapeutic Products are medicines, medical devices, natural health products, and pharmaceutical ingredients.
Currently, the Medicines Act 1981 is the main legislation enabling access to safe medicines and medical devices. Natural health products are regulated by the Dietary Supplements Regulations 1985 under the Food Act 2014.
The bill would repeal most provisions of the Medicines Act, except those relating to pharmacy ownership, and revoke the regulations made under the Act. It would also revoke the Dietary Supplements Regulations.
Changes that the bill proposes to include:
• requiring therapeutic products to receive a market authorisation before they could be imported into, exported from, or supplied in New Zealand
• providing for the regulation of a range of controlled activities
• establishing a Therapeutics Products Regulator
In its submission, Te Puna Ora o Mataatua has argued that the Bill fails to engage with Te Tiriti o Waitangi in any meaningful way, due to ineffective policy and consultation process and it has proposed a series of recommendations and amendments to the Bill.
Read the full submission here: https://bit.ly/3FhXakq