Data Sheets
Consumer Medicine Information
Data Sheets
The requirements for medicine data sheets are contained in the Medicines Regulations 1984 and the New Zealand Regulatory Guidelines for Medicines Volume 1: Guidance notes for applicants to distribute new and changed medicines and related products.
Data Sheets submitted to Medsafe on diskette will be available on this web site.
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Consumer Medicine Information
New Zealand pharmaceutical companies are encouraged to produce Consumer Medicine Information (CMI), however, it is not a mandatory requirement. All CMI must be produced in accordance with the New Zealand Regulatory Guidelines for Medicines Volume 4: Consumer Medicine Information (Microsoft Word document 3,452KB). The guideline was developed by a working party that included industry representatives, consumers, doctors and pharmacists.
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Preparing CMI
Getting started
Firstly download and read the New Zealand Regulatory Guidelines for Medicines Volume 4: Consumer Medicine Information (Microsoft Word document 3,452KB). Also download the Vocabulary for CMI (Microsoft Word document 112KB). It was developed by a group of Australian physicians, industry representatives, CMI writers and a consumer representative to assist writers to translate medical terms into words suitable for use in CMI. However, careful thought and consideration for the best way to express terms in consumer-friendly language is still required.
Some handy hints when preparing CMI
- Ensure CMI is referred to as CMI, not CPI (Consumer Product Information) as it was formerly known in Australia. Note: it is Consumer Medicine Information, not Consumer Medicines Information
- Preferably only include the trade mark symbol "™" or registered trade mark symbol "®" the first time the medicine trade name is used (ie. in the title) rather than every time.
- For easy identification, consider including the strength(s) and dose form(s) of the medicine as the subtitle.
- Sometimes CMI includes the brand name of other medicines (e.g. interactions with certain medicines). If the CMI is going to be used in New Zealand and Australia, consider including all the brands and indicating in which country they are available.
- If it is unlikely that the medicine will be dispensed in the original pack, consider rewording or removing references to tampering or expiry dates.
- The National Poisons Centre has both urgent and non-urgent phone numbers. Please use the urgent 0800 numbers (i.e. 0800 POISON and 0800 764 766) in CMI.
- Many companies include in CMI a free phone number for consumers to call. If it is an Australian number, please arrange with the local phone company for calls to be free if lodged in New Zealand, as well as Australia. Australian free phone numbers are not automatically free if the call is lodged in New Zealand.
Producing a CMI suitable for use in New Zealand by adapting an Australian CMI
It is essential when producing a New Zealand CMI by adapting an Australian CMI, that all aspects of the New Zealand CMI are consistent with the approved New Zealand product and data sheet eg. indications, dosage, excipients etc.
If the CMI is intended for use only in New Zealand:
- ensure all side effects that are common (>1%), serious or prolonged (see the guideline for further information) are included
- delete the Australian R number
- if it is unlikely that the medicine will be dispensed here in the original pack, consider deleting the number of doses, weight or volume. It can be confusing if the CMI states the bottle contains 100 tablets and the patient is dispensed 20.
- if required, include New Zealand-specific safety information (as required by the MARC or MAAC, and listed in the New Zealand Regulatory Guidelines for Medicines Volume 1)
- change the company address to the full New Zealand company address
- change the Poisons Centre phone number to the New Zealand 0800 numbers (0800 POISON or 0800 764 766)
- change the date of preparation of the CMI
There may be other sections of the CMI that require alteration so check that the CMI is fully compliant with the CMI guidelines.
Companies are encouraged to consumer test the new CMI.
If a CMI is intended for use in both New Zealand and Australia:
- it is essential that the indications, dosage etc are identical in both countries. If they are not either submit a CMN in one country seeking an identical indication/dosage or market the product with separate CMIs.
- it is acceptable to include the phone number of the Poisons Centre in both countries, the full New Zealand and Australian company addresses etc.
Starting from scratch
The 'Content' section in volume 4 of the Regulatory Guidelines outlines what needs to be in CMI, and the 'Style' section gives guidance on the format. The Usability Guidelines has more detailed information on an appropriate format and how to express information.
A number of core CMI’s have been produced by Australian pharmaceutical companies (co-ordinated by the Medicines Australia) who have medicines in the particular therapeutic class. The core CMI is a good starting point for companies drafting CMI. The New Zealand approved indications, dosages, excipients etc must be included and the CMI must be carefully checked to ensure it is consistent with the approved New Zealand data sheet and conforms with volume 4 of the Regulatory Guidelines.
Core CMIs are available from Medicines Australia or at this website - http://www.medicinesaustralia.com.au/pages/page38.asp
Companies producing CMIs, either from scratch or core CMIs, are encouraged to conduct diagnostic consumer testing of the CMI before it is finalised.
The regulatory process
Companies must complete the CMI regulatory process before they market a medicine with a CMI as a package insert, or distribute the CMI. The process is completed when the CMI is published on this web site. Note: no CMI will be published on the web site until the medicine has been given consent to distribute.
Companies are required to self-monitor their CMI against the requirements of the CMI guidelines. There is no assessment or approval of the CMI by Medsafe.
- The regulatory process involves sending Medsafe:
- a paper copy of the CMI
- a disk containing the electronically formated CMI (or e-mail the CMI). Do not use a code to name the CMI - use the medicines trade name
- a declaration that the CMI conforms with volume 4 of the Regulatory Guidelines (note: a CMI Declaration Form (Microsoft Word 21KB) (included in volume 4)
- Alternatively, Medsafe will accept fully electronic submission of CMI. This involves e-mailing these two documents:
- a Word document of the CMI
- a completed CMI Declaration Form (Microsoft Word 21KB) (can be a scanned copy or PDF version)
Ideally separate the CMI regulatory process from a changed medicine notification or a new medicine application.
CMI must be provided to Medsafe as a Microsoft Word for Windows document or in Rich Text Format (RTF). PDF format is unacceptable. Medsafe has developed a Macro to convert the Word or RTF document to html (the language used in web sites).
The CMI submitted to Medsafe must be identical to the CMI used by the company. If there are any differences, they must be declared.
Formatting the electronic copy
For efficient conversion to html and consistency in style, CMI must be formatted in a particular way, using specific styles for sections of text.
A Microsoft Word template (19KB) is available to assist users of Microsoft Word for Windows. It contains all the styles to be used when formatting CMI, and displays the CMI in Word as it will appear on the Internet.
To use the template (CMI.dot), firstly download it to your User templates folder - usually C:\MSOffice\Templates. To ascertain the location of your templates folder, select Tools/Options from the Menu bar then select the File Locations tab. Note: when the template is opened it looks like a blank word document.
To use the template, select File/New from the Menu bar and choose the CMI template. Then choose Insert/File from the Menu bar and select the CMI document in Word. By inserting the CMI from Word into the template, a new document is created with the same content as the original word CMI document, but with different formatting. Alternatively, type in the CMI directly.
Next highlight the text which needs to have its style changed, and choose
the appropriate style from the style box (the box on the far left of the
formatting toolbar).
Note: normal text does not require highlighting as it is the default style.
| Style | Where it should be used |
|---|---|
| Title | name of the medicine |
| Subtitle | strength, dose form and for the name of the active ingredient(s) |
| Heading 1 | major headings (eg. Side Effects) |
| Heading 2 | secondary headings (eg. Taking other medicines) |
| Heading 3 | sub-headings |
| List Bullet | dot points |
| List Number | numbered lists |
| Normal Indent | indented text |
| Normal | all other text |
Consult a Word user manual if you are unfamiliar with the use of styles, the style box etc.
To assist formatting CMI for the Internet:
- Where possible, do not use any other styles within a numbered list. If you need to use a different style within a numbered list, e.g. where sub-text contains dot points, highlight the whole of the numbered list text as List Number then select the text that is dot pointed and change its style to List Bullet in the style box.
- Symbols (e.g. ™, °, ®) can be inserted in 2 ways:
(a) from the Character Map in Accessories using Arial as the font. Do not use Insert/Symbol in Word. Accessories is located in Windows not Word.
or
(b) hold the "Alt" key down and insert the appropriate code - using the number pad with the number lock on.
Character Alt code µ 0181 ° 0176 ™ 0153 ® 0174 ½ 0189 ¼ 0188 - Ending a paragraph with Enter results in a one line gap between that paragraph and the next when the CMI is published on the Internet. To eliminate these gaps, end paragraphs with Shift-Enter. Note: there is no gap between bulleted lines of text.
- To superscript and subscript text, use the superscript and subscript tick boxes from Format/Font (on the Menu bar). Do not use Character Spacing (on the same Menu).
- Do not insert column breaks if using the 3 column format.
Diagrams can be included in CMI (but not pictograms). Companies need not format diagrams in any special way - Medsafe will convert them to "gifs" so that they can be viewed correctly on the web.
Finally, save the new CMI as a word document (or in rich text format) on a diskette and send it to Medsafe for lodging in the database and on this web site. Note: Medsafe will not accept CMI in a PDF format
See volume 4 of the Regulatory Guidelines for further information about CMI.