How can Maxx Pharma assist you in New Zealand?
Maxx Pharma is a New Zealand registered company that can act as a third-party sponsor by:
- Sponsoring companies that do not have an established legal entity in New Zealand
- Submitting an application to add a medicine onto Medsafe’s Therapeutic Products Database
- Submitting a notification to the Web Assisted Notification of Devices (WAND) database to be able to supply a medical device
- Maintaining sponsorship of therapeutic products and paying annual charges to regulatory authority, as required in New Zealand
- Undertaking ongoing legal responsibilities of a sponsor and fulfilling the necessary obligations
Sponsors have ongoing legal responsibilities once a medicine is entered into the Therapeutic Products Database, and a medical device is notified to the WAND database, including:
Medicines
- Complying with the requirements of the Medicines Act 1981 and the Medicines Regulations 1984
- Being a manufacturer, importer, proprietor in New Zealand or their duly appointed agent by ensuring all relevant licenses and certificates are present and valid
- Producing on demand and understanding the significance of current specifications, certificates of analysis and batch documentation for each batch of the medicine distributed in New Zealand
- Complying with any conditions associated with consent or imposed on the supply of goods
- Providing technical data and advice, as well as notifying the regulatory authority of any changes to the medicine if required
- Accepting responsibility and maintaining required records for the distribution and supply of unapproved medicines
- Undertaking the reporting of adverse reactions for medicines
- Notifying Medsafe of an issue that requires corrective actions, such as recalls and withdrawals
- Accepting responsibility and complying with the requirements for advertising and promotion of medicine
Medical Devices:
- Ensuring up-to-date information regarding manufacturers, licenses, sponsor details or any changes to the device is notified to Medsafe
- Having procedures in place to ensure compliance with Medsafe vigilance and regulatory requirements
- Using the product in accordance with the approved device details