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Consultations

Revised: 27 May 2013

Proposed Business Rule for Publication of Data Sheets

23 April 2012

To:
Product sponsors

The purpose of this letter is to:

Background

In 2010 Medsafe initiated a project to convert all published data sheets from HTML to PDF to reduce formatting errors and to simplify the publication process. During the course of that project it was identified that there were no data sheets available for some prescription and restricted medicines.

In August 2011, amendments to the Medicines Regulations came into effect making it mandatory for approved data sheets for all prescription medicine and restricted medicine products to be submitted to Medsafe in electronic form for publication on its website (see regulations 52 & 53 of the Medicines Regulations 1984, as amended by the Medicines Amendment Regulations 2011).

The problem of the missing data sheets could have been overcome by simply requiring data sheets to be published and maintained for all prescription medicine and restricted medicine products regardless of whether the product was available in New Zealand. However, this could have imposed additional compliance costs on industry without significant benefit to patient safety.

In order to improve the coverage of published data sheets, while at the same time minimising compliance costs for industry, Medsafe proposes to make changes to the way it records the market status of products and has developed a new business rule for publishing data sheets.

Market status of approved products - Available or Not available

To facilitate appropriate handling of data sheet publishing, Medsafe intends to record the market status of a product in the SMARTI database as available or not available.

A product is available if:

or

or

Approved products will in future be recorded in the SMARTI database as "Consent granted - Available" or "Consent granted - Not available".

New business rule for publication of data sheets Under the proposed new business rule the following would apply:

  1. If a product that is a prescription or restricted medicine is available, the approved data sheet will be published on the Medsafe website and must be maintained by the sponsor.
  2. If a sponsor notifies Medsafe that a product is not available (i.e. will not be supplied even on request), the sponsor will not be required to submit the approved data sheet for publication on the Medsafe website, or to maintain the currency of the data sheet, during the period the product is not available.
  3. If a product has been notified to Medsafe as not available and the sponsor wishes within the ensuing 5 years to commence supply of the product, a changed medicine notification will be required if there have been any changes to the product or the data sheet. Within 10 days of approval of the CMN, the approved updated data sheet will need to be submitted to Medsafe for publication on its website.
  4. If a medicine remains not available and the regulatory file is not maintained for a period of 5 years, the consent to distribute that medicine will lapse. If the sponsor subsequently wishes to distribute the medicine, a new medicine application will be required. The data requirements and fee will depend on the nature of the differences between the previously approved product and the product the sponsor now wishes to distribute.
  5. If a medicine is distributed for a period of time and is then discontinued, the data sheet will remain on the Medsafe website until the sponsor notifies Medsafe that stock in the supply chain has been used up and the product is now not available. Recommencing supply of a discontinued product will require submission of a changed medicine notification or a new medicine application, depending on the period that has elapsed since the product became not available.

Implementation

It is proposed that implementation of the new business rule relating to publication of data sheets will proceed as follows:

During June 2012 Medsafe sends sponsor a list of currently approved products for which a data sheet is required but is not published.
By 27 July 2012 Sponsor notifies Medsafe of any products that are "Not available" and do not therefore require data sheets to be published.
By 5 October 2012 Sponsor submits the approved data sheet for publication, or submits a CMN for approval of the updated data sheet, as appropriate.

 

Providing feedback

The proposed business rule has been developed in consultation with Medicines New Zealand and the Self-Medication Industry Association. You are now invited to send any feedback, by 25 May 2012, to:

Sarah Reader
Manager Product Regulation
Medsafe
PO Box 5013
Wellington 6145

OR

sarah_reader@moh.govt.nz
with 'Data sheet consultation' in the subject line.

Yours sincerely

Sarah Reader
Manager Product Regulation

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