Published: 30 September 2012
Consultations
Outcome of Consultation on the Proposed Business Rule for Publication of Datasheets
30 September 2012
To: Product sponsors
The purpose of this letter is to:
- Advise you of the outcome of Medsafe's proposed new business rule for the publication of data sheets on the Medsafe website.
- Inform you of Medsafe's decision to not require sponsors to maintain or publish data sheets on the Medsafe website for products that are not available.
- Provide further detail on the new requirements and processes.
Guideline on the Regulation of Therapeutic Products in New Zealand, Part 10.
Background
In April 2012, Medsafe published a proposed new business rule for the publication of data sheets on the Medsafe website, and sought feedback on the proposal by 25 May 2012.
Medsafe received four submissions on the proposed changes (two from industry associations and two from sponsors of medicines).
Outcome
From 1 November 2012, sponsors (and their authorised agents) will not be required to maintain or publish data sheets on the Medsafe website for medicines that are not available. Sponsors of prescription and restricted (pharmacist-only) medicines that are available will be required to maintain and publish data sheets on the Medsafe website.
A sponsor may still choose to maintain and/or publish a data sheet for any product unless consent has lapsed.
A summary of the feedback received, and Medsafe's decisions following consideration of the feedback, is provided below.
Feedback received
Only four submissions were received which implies most sponsors supported the proposed business rule for the publication of data sheets on the Medsafe website.
From the four submissions received, all submitters agreed that data sheets should not be required to be maintained or published on the Medsafe website for products that are not available.
Submitters requested that submission of CMNs should be sufficient to maintain consent even if a product is not available.
Issues raised in the consultation
The submissions raised the following issues for consideration by Medsafe:
- Sponsors should be informed before the registration situation
is changed from not available to consent lapsed.
Medsafe will notify sponsors approximately three months before consent will lapse for products that have a registration situation of not available and no regulatory activity. Sponsors will then have the opportunity to update the regulatory file to maintain consent. - The CMN forms should be updated to include a checkbox to identify
if a product is available or not available.
The CMN forms will be updated to include a checkbox to indicate whether a product is available or not available. If the product is not available the date the product was last supplied in New Zealand will be required to be provided. The Declaration to accompany a Data Sheet submitted for Publication (Form 10.3) will be updated to include a checkbox to indicate whether a product is available or not available.
- The terms available and not available should be used consistently
throughout the therapeutic products database and ideally flow through
to the NZULM/NZMT process.
The terms will be used consistently throughout the therapeutic products database. This feedback will be passed onto NZULM to take into consideration as part of the NZMT process. - Alternative definitions for available and not available were
suggested.
The proposed definition for available was:- It is marketed in New Zealand
- It is not actively marketed and not available through normal distribution channels, but is available from the sponsor on request
- The sponsor has not notified Medsafe that the product is not available
- It is currently marketed in New Zealand
- It can be sourced from the company on request, even where it is not actively marketed.
- The sponsor has not notified Medsafe that the product is not available
These alternative definitions have the same meaning as intended in the consultation document. Therefore the alternative wording is acceptable if this adds greater clarity for sponsors. - CMNs should continue to be able to be submitted for products
that have a registration situation of not available.
CMNs can continue to be submitted for products that have a registration situation of not available. However, prior to distribution a CMN must be submitted for evaluation to ensure regulatory details are current, e.g. updates required to data sheets or consequential changes arising from submission of updated drug master files have been addressed. CMNs should be submitted 90 days prior to commencing distribution.
Medsafe will not advise sponsors of unavailable medicines that innovator or market leader data sheets have been updated. Sponsors that do not wish to maintain data sheets will need to incorporate all updates prior to distribution and submit these changes for evaluation. Self-assessable change notifications will not be accepted to change the status of prescription or restricted medicines from not available to available.
Sponsors will be able to provide a justification for not submitting a CMN prior to distribution commencing. Justification can consist of proof that the regulatory file has been fully maintained. Justifications should be provided 90 days prior to commencing distribution.
Next steps
Medsafe will write to sponsors by 1 November providing them with a list of currently approved products for which a data sheet is required but is not published.
Sponsors will have until 1 December to notify Medsafe of any products that are not available and therefore do not require a data sheet to be published.
Sponsors must submit an approved data sheet for publication, or submit a CMN for approval of an updated data sheet, for available prescription or restricted medicines by 1 December.
Medsafe will replace the term "discontinued" with "approval lapsed" by 1 November.
From 1 February 2013 Medsafe will write to sponsors if approval is due to lapse. Sponsors can then lodge a CMN to maintain consent.
Please refer to Guideline on the Regulation of Therapeutic Products in New Zealand, Part 10 for further information on submission of data sheets.
Yours sincerely
Sarah Reader
Manager Product Regulation
Medsafe
