This bill proposes to amend the Medicines Act 1981 to clarify the appropriate use of provisional consents to sell and use medicines in New Zealand. The bill also validates existing consents. The bill will ensure that New Zealanders continue to have timely and safe access to effective medicines through this channel. Section 23 of the Act allows medicines and vaccines to be provisionally consented for early access if there is a significant clinical or public health need. Importantly, that clinical need must be weighed against the risks as prescribed in section 22(1) of the Medicines Act.