The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its guideline on pharmacovigilance after receiving support for changes it proposed late last year.
Summary
About the consultation
Medsafe consulted on proposed updates to GRTPNZ: Pharmacovigilance.
The consultation was aimed at sponsors* of medicines that are approved for use in New Zealand and organisations involved in pharmacovigilance activities (ie, on behalf of sponsors).
The Guideline was last updated in 2020, with edition 2.2.
The consultation opened on 2 November 2023 and closed on 14 December 2023.
More information about the consultation.
Submissions received
We received 15 submissions. All submissions were from sponsors or organisations involved in pharmacovigilance activities.
You can view the submissions that we have permission to publish.
Medsafe would like to thank all those who took the time to respond to the consultation and provided comments.
Outcome
Most respondents agreed with the proposed updates to GRTPNZ: Pharmacovigilance.
Several respondents suggested changes to wording, layout and/or formatting to improve clarity. There were also requests to add examples or further detail to some sections to improve understanding and interpretation. Where appropriate, we have incorporated these suggestions into the revised Guideline.
Revised Guideline
We have published the revised Guideline.
• GRTPNZ: Pharmacovigilance (Edition 3.0) (PDF, 521 KB, 36 pages)
Implementation date
GRTPNZ: Pharmacovigilance (Edition 3.0) comes into effect on 1 July 2024, and must be used from this date.
However, sponsors may use the revised Guideline from the day of publication (20 March 2024).
Enquiries
For any questions about this consultation, please email: [email protected]
*A sponsor is defined as an individual, company, institution or organisation that is responsible for the medicinal product in New Zealand.
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