Published: 11 November 2016
Revised: 24 March 2017

Consultations

Outcome of Consultation on proposed changes to the data sheet format and part 10 of the Guideline on the regulation of therapeutic products in New Zealand.

About the consultation

This project and consultation was initiated due to inconsistency in New Zealand data sheets. The most sought after information by healthcare professionals is often not near the beginning of the document, increasing the time it takes to locate desired information. In addition, the order of the sections is not consistent between sponsors, further adding to the time taken to locate information. The consultation ran between 12 February and 31 March 2016.

Through the consultation process, Medsafe sought comments from interested parties on:

  • adopting the SmPC format
  • the proposed changes to part 10 of the GRTPNZ
  • the explanatory guide
  • implementation time lines
  • the future name for data sheets
  • use of new technologies
  • publication of information for medical devices

Consultation documents

The consultation documents included:

Submissions received

Submissions received in response to the consultation paper are published below.

Note: Three organisations requested that their submission be kept confidential.
Personal information that can identify submitters has been removed (where requested).

Consultation feedback

All 28 submissions have been reviewed by Medsafe. Attached below is a summary of the consultation submissions received and an outline of Medsafe's responses.

Adoption of the SmPC format

Eighteen submissions indicated they were in favour of adopting the SmPC format, eight submissions disagreed with the proposal and in two submission responses the authors' opinion was unclear. Therefore Medsafe has decided to adopt the SmPC format for data sheets.

The feedback from this consultation has been used to update the guideline and associated documents.

Changes to the data sheet format and part 10 of the GRTPNZ: Summary of consultation responses (pdf 249 KB, 20 pages)

Part 10: Requirements for information for prescribers and consumers Edition 7.0 (pdf 117KB, 13 pages)

New Zealand data sheet Explanatory Guide 1.0 (pdf 241 KB, 25 pages)

New Zealand data sheet template (Word 17 KB, 2 pages)

Changed Medicine Notification - Form A (Word 151 KB, 20 pages)

Changed Medicine Notification - Form B (Word 124 KB, 17 pages)

Implementation

Timing

The implementation start date will be 1 March 2017 and the completion date will be 28 February 2019 (2 years for completion of the change). All NMAs in evaluation at the start date will need to have a data sheet in the new format for publication on completion of the NMA evaluation process. In the unlikely scenario of NMAs which have been gazetted but no data sheet published, the current format will be accepted.

For existing data sheets CMNs may be submitted to change to the new format as soon as the outcome of this consultation is published. Changed data sheets will not be accepted after 1 March 2017 unless they are in the new format.

Process

Sponsors may update their data sheets to the new format at no additional charge during routine CMNs (for any update) and SACNs. Please select the “reformat” option as well as the reason for the change on the form.

It is recommended that sponsors submit no more than 10 updated data sheets at one time.

Updating current approved data sheets

It was noted during the consultation that some data sheets require additional changes over and above a reshuffle of the information. The following changes may be included for no additional charge providing there are no changes to the approved information.

Indications

Indications should be updated to include the age (range) for which the product is indicated, in line with the approved information on dose.

Dose and administration

Paediatric doses are only required to be included in the data sheet if the product is indicated in children. This should be obvious from the indication.

The dose and administration information are contained in the same section of the SmPC format. It is not necessary to change this section unless it would improve the clarity of the information. It is necessary to clearly separate out the dose information for special populations and different indications. It is recommended that sponsors use sub-headings to improve clarity if there are a number of different indications/ special populations with different dose requirements.

Clinical trials information - efficacy data

For existing data sheets only, it is acceptable to relocate this information without rewriting to SmPC requirements. However, future updates to this section should be in the SmPC style.

Effects on ability to drive

Some data sheets do not currently contain any information about driving. This information will need to be added. The explanatory guide has been updated to include more information on how to do this.

Undesirable effects

This section may require considerable revision to meet SmPC requirements. Medsafe is cognisant of the fact that the frequency of undesirable effects may not be known, particularly for older and generic medicines. In these cases only, it is acceptable to leave this information out.

Shelf life

This should be the same as contained in the Therapeutic Product Database Record (TPDR). This information is already accessible in the product application search on the Medsafe website. For the convenience of healthcare professionals it should also be included in the data sheet.

Enquiries

Any questions relating to submissions should be directed to Medsafe via email to: medsafeadrquery@health.govt.nz

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