New Zealand customer enforcing Medsafe Clinical Trial Authorisation (CTA) requirements

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, is a business unit of the Ministry of Health and the authority responsible for the regulation of therapeutic products in New Zealand. It is important to be aware that New Zealand customs is enforcing the requirement to provide a copy of the Medsafe Clinical Trial Authorization (CTA) letter to complete the import clearance for clinical trial supplies in New Zealand. The Medsafe CTA letter is an authorization to import specific medicinal products to authorized clinical sites; the authorization is valid for the duration of the study.

Here are some key points to remember:

• It is important that the customs invoice information show identical information as listed on the Medsafe authorization (protocol number, investigator site details, product description/name).
• The medicinal products listed on the Medsafe Authorization are imported with 0% GST rate under Regulation 65; other consumables relating to the clinical trial, including associated medicaments which are not listed on the Medsafe Letter, could be subject to 15% GST payment.
• In the absence of the Medsafe letter, consignments could be subject to 15% GST payment as well as potential customs delay.
• If material is subject to an additional import control/license from the Ministry of Primary Industries, e.g. animal product, please ensure that a copy of the import license is supplied for the transportation.

Avoid delays: Have a copy of the Medsafe Clinical Trial Authorization (CTA) letter

If you are not already doing so, please ensure that you are implementing the above requirements. Should you have any questions or need additional guidance, please contact your Quick representative.