Revised: 27 May 2013

Consultations

Review of the submission and publication processes for data sheets and Consumer Medicine Information on the Medsafe website

16 October 2009

To:
Product sponsors
Regulatory affairs consultants

The purpose of this letter is to:

• Advise you of planned changes to the submission and publication processes for data sheets and Consumer Medicine Information on the Medsafe website.
• Seek feedback, by 20 November 2009, on the planned changes and the timeline for implementation.

Background

Each data sheet and Consumer Medicine Information (CMI) is produced, maintained and owned by the sponsor responsible for the medicine. These documents are submitted for publication on the Medsafe website to provide healthcare professionals and consumers with ready access to medicine information.

Currently, sponsors are required to submit an electronic copy of each new or updated data sheet or CMI to Medsafe in Microcoft Word or Rich Text Format (RTF). Staff at Medsafe convert these documents into Hyper Text Markup Language (HTML) format for publication on the website.

This conversion process introduces the potential for text, symbol and formatting errors in the published document. For this reason, additional time is taken by Medsafe to check for such errors in the docments before publication on the Medsafe website. Checking the reformatted documents is time-consuming and errors can be difficult to detect. This is a cause of concern for both Medsafe and sponsors.

Review of submission and publication processes

Medsafe has undertaken a review of the submission and publication processes for data sheets and CMI on the Medsafe website.

The aim of this review was to identify ways of improving the efficiency of the publication process and the quality of the information published on the Medsafe website.

Two options for the submission of data sheets and CMI have been identified. Both options would improve efficiency and remove the potential for errors and unintended changes by Medsafe during the conversion process.

1. Option 1 - Sponsors submit data sheets and CMI in HTML format
   
   Under this option, sponsors would submit data sheets and CMI to Medsafe in HTML format. This would mean that the responsibility for converting documents to HTML and checking for errors would rest with the sponsor. Medsafe would publish the submitted documents without any further formatting or checking.
2. Option 2 - Sponsors submit data sheets and CMI in Portable Document Format
   
   Under this option, sponsors would submit data sheets and CMI to Medsafe in Portable Document Format (PDF). To maintain usability, the documents would need to be searchable. Therefore scanned documents would not be accepted. Medsafe would publish the submitted documents without any further formatting or checking.

Under either option the sponsors would be responsible for ensuring the content of the document is correct and the formatting of the document is appropriate. Medsafe would not check or make any changes to data sheets or CMI that have been submitted for publication. Should Medsafe or the sponsor note any required amendments, the changes would need to be made by the sponsor and the document resubmitted.

It is anticipated that new and updated data sheets and CMI would be published on the Medsafe website within one week of receipt.

Following the publication of a new or updated data sheet or CMI, it it proposed that Medsafe will notify the sponsors through the weekly 'Additions to Medsafe's website' e-mail. Individual letters and e-mails would no longer be issued as notification. Therefore individuals involved in the submission of data sheets and CMI are encouraged to subscribe to the weekly e-mail alert (www.medsafe.govt.nz/regulatory/subscribe.asp)

Medsafe is seeking comment from sponsors before making a final decision on the format for submission of data sheets and CMI.

Timeline for submitting data sheets and CMI in the new format

It is proposed that new and updated data sheets and CMI for publication on the Medsafe website after 1 January 2010 be submitted in the new format. From that date, any documents received in Microsoft Word or RTF will be returned to the sponsor for reformatting.

The information contained in a number of data sheets and CMI currently published on the Medsafe website is likely to be updated during the first six months of next year. These data sheets and CMI can be submitted and published in the new format as they are updated. However, remaining data sheets and CMI will need to be resubmitted in the new format (without any changes to the content) and re-published on the website.

It is proposed that sponsors would have until 31 August 2010 to resubmit all data sheets and CMI in the new format. The resubmission of a data sheet in the new format, without any changes to the content, would incur no fee. As with all CMI, the resubmission of these documents in the new format (with or without any changes to content) would incur no fee.

Medsafe welcomes your feedback on the proposed timeline for resubmitting data sheets and CMI in the new format.

Next steps

Feedback is sought on the proposed submission and publication processes and the timelines for publication of data sheets and CMI in a new format.

Please provide any feedback by 20 November 2009, by completing the attached form electronically and emailing it to Medsafe with 'Data sheet and CMI Consultation' in the subject line.

Consultation Comments Form (Microsoft Word document 30kb)

Medsafe will advise sponsors of its decision regarding the revised submission and publication processes via the Medsafe website, by the end of November 2009. Further detailed information on the processes will be provided at that time.

 

Yours sincerely

 

Abby Cutfield
CMI Co-ordinator
Advisor Science, Pharmacovigilance
Clinical Risk Management
Medsafe