Interchangeable Status (IMM)
7 July 2006
Medsafe wish to advise that publication of the Interchangeable Multi-source Medicines (IMM) List on the Medsafe website is to be discontinued from 7 July 2006.
The reasons for this decision include:
- The interchangeability list was originally introduced in the early 1990's in response to concerns regarding efficacy and safety by health professionals over the introduction of generic medicines onto the NZ market. It was felt that since this time both patients and health professionals have become far more accepting of the use of generic medicines.
- An IMM list is unlikely to be a feature of the Australia New Zealand Therapeutic Products Agency.
- The clinical safety and efficacy of generic medicines is usually established by the use of a biostudy against the innovator product or current market leader. Consequently, for most generic medicines, interchangeability is a 'fait accompli'.
The clinical issue of interchangeability of medicines still remains a feature of the evaluation process for new generic prescription medicines. Where new generic medicines are not considered to be interchangeable, the non-interchangeability of a medicine will be required to be stated within a product's data sheet. Medsafe also intends to maintain a list of medicines determined not to be interchangeable and may post this on the Medsafe website if necessary.
Please note that Section 2 of Section 14.4.1 (Medicines considered to be non-interchangeable) of the NZRGM Volume 1, 5th Edition still remains valid.
A revised Section 14.4 "Interchangeability of multi-sourced medicines" that includes the above changes, will be published on the Medsafe web site shortly.