Revised: 18 April 2017
Data Sheets and Consumer Medicine Information (CMI) are published here on behalf of pharmaceutical companies. If you cannot find the information you are looking for, or have any queries about this information, please contact the pharmaceutical company named as the sponsor in the data sheet or CMI.
In March 2016, Medsafe held a consultation on the format of the data sheets. As a result of this consultation, Medsafe has now confirmed that the data sheets should follow the European Summary of Product Characteristics (SmPC) format. This means that the information will be ordered in the same sequence in all data sheets with the clinical information near the beginning. In addition, there will be a summary table at the end of each data sheet outlining the changes from the previous version.
The change-over has already startged. Companies have until 28 February 2019 to reformat their existing data sheets.
Additional information can also be found on the Medsafe website at the following links
Data sheet template (Word 18 KB, 1 page)
Data sheet template explanatory guide (PDF 241 KB, 25 pages)
Tips for changing to the new data sheet format
Part 10: of the Guideline on the Regulation of Therapeutic Products in New Zealand (PDF 117 KB 13 pages)
Information on the outcome of the consultation including the Summary of Consultation Responses
Data sheets and CMIs are published on the Medsafe website in Portable Document Format (PDF).
To read a PDF you need Adobe Acrobat Reader installed on your computer.
Download the latest free version of Adobe Acrobat Reader from the Adobe website.
Commercial Use: Permission must be obtained from the sponsors (pharmaceutical companies) of the medicines concerned.
CMI is useful information about your medicine and is written especially for you. CMI contains advice such as what the medicine is used for, how it should be taken, what side effects can occur, whether you can drive or drink alcohol while taking the medicine, and what to do if you miss a dose. However, CMI do not contain all the available information about the medicine. Ask your doctor or pharmacist if you have any questions or concerns about taking the medicine.
Pharmaceutical companies are responsible for producing CMI. However, in New Zealand there are no legal requirements for them to do so. The CMIs that are on this website have been written by pharmaceutical companies, using Guidelines set by Medsafe. The companies self-assess what information goes in each CMI against the requirements of the Guidelines. Medsafe does not evaluate or approve CMIs, therefore Medsafe is not responsible for the information contained in a CMI.
Each month, more CMIs are added to this website. If you cannot find a CMI for your medicine, it is most likely because the pharmaceutical company that makes or distributes your medicine has not yet written the CMI. Your doctor or pharmacist should be able to provide you with the information you need.
Patients have the right to treatment that meets appropriate ethical and professional standards, including the right to be fully informed about the risks and benefits relating to efficacy and safety of medicines.