Published: 26 November 2025
Information for Industry
Requesting adverse reaction information – Guidance for industry
- Requesting information for a certain time period
- Requesting information on certain report numbers
- Timing
- Disclaimer
If you are a sponsor of a medicine in New Zealand and wish to request information about suspected adverse reactions to your medicine that have been reported to the New Zealand Pharmacovigilance Database, please follow the guidance below.
Medsafe and the Centre for Adverse Reactions Monitoring (CARM) run a pharmacovigilance system to monitor medicine safety in New Zealand. To support medicine sponsors with their pharmacovigilance obligations in New Zealand, Medsafe shares deidentified adverse event information with sponsors on request.
Requesting information for a certain time period
This is our preferred approach.
The sponsor's contact person for pharmacovigilance in New Zealand should make the request for adverse reaction information for the medicines they are responsible for.
Email the request to: carmreport@health.govt.nz.
Include the following information in the email:
- if you have not already notified Medsafe that you are the sponsor's contact person for pharmacovigilance, please confirm that you are the contact person for the suspect medicine(s) requested
- the time period requested (start and end dates)*
- a list of the medicines you are responsible for, including the TT50 numbers.
* To allow time for report processing and coding, please choose an end date that is at least one month in arrears. For example, for a request on 1 May, choose an end date of 31 March.
Requesting information on certain report numbers
Sponsors may have identified particular reports in Medsafe's Suspected Medicines Adverse Reactions Search (SMARS).
To request further information about these reports, the sponsor's contact person for pharmacovigilance in New Zealand should make the request.
Email the request to: carmreport@health.govt.nz.
Include the following information in the email:
- if you have not already notified Medsafe that you are the sponsor's contact person for pharmacovigilance, please confirm that you are the contact person for the suspect medicine(s) in the reports requested
- Medsafe report reference numbers (from the SMARS database) – up to a maximum of 5 report numbers.
Timing
Medsafe aims to respond to all data requests within two weeks. In general, requests will be provided with an excel spreadsheet.
Disclaimer
While reasonable care is taken to ensure that the information is an accurate record of the adverse events reported to Medsafe, we do not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.
The New Zealand Pharmacovigilance Database is constantly being updated. Information may change due to:
- follow up information being received
- duplicates being identified and combined into a single report
- reports being updated as part of data quality assurance activities.
