is New Zealand’s Medicines and Medical Devices Safety Authority. It is a
government run business unit in the Ministry of Health. Medsafe regulates medicines
and medical devices in New Zealand and administers the Medicines Act 1981 and
Medicines Regulations 1984.
ensure medicines are at a satisfactory standard of safety, quality and efficacy
for New Zealander’s. They ensure that the requirements and standards are met by
companies in the process of manufacturing, storing and distribution of
medicines. As well, they provide information and keep consumers and health
professionals up to date on the safety of medicines and any changes made.
regulate medicines through a process of pre-market approval and post-market
surveillance. Pre-market approval assesses new medicines and medicines with
changes are at satisfactory standard for quality, safety and efficacy for their
therapeutic purpose. New medicines must be approved by the Minister of Health prior
to them being sold in New Zealand’s market. Medicines already on New Zealand’s
market that are altered must be approved by the Director General of Health.
Post-market surveillance monitors medicines on the market to ensure that they remain
safe to use. This is done through monitoring adverse reactions reported in New
Zealand and internationally, investigating complaints, and auditing and
licensing medicine manufacturers.
is the secretariat for three committees, the Medicines Classification Committee
(MCC), the Medicines Assessment Advisory Committee and the Medicines Adverse
Reactions Committee. The committees are appointed by the Minister of Health
under section 8 of the Medicines Act 1981. The MCC’s purpose is to recommend the
classification of, and any other matters relating to access to medicines to the
Minister of Health. Medicines can be classified as one of three categories.
These are prescription medicines, restricted medicines or pharmacy only
twice a year. It is made up of six members who are appointed for a three-year
term. The New Zealand Medical Association, the Pharmaceutical Society of New
Zealand and the Ministry of Health each nominate two members. One of the
Ministry of Health’s nominees is appointed as chairman. Members can only be appointed
for a maximum of two terms.
agendas are published on Medsafe’s website. There is a public consultation
period of about six weeks to allow for comments on the agenda items. The
publics comments are also published on the Medsafe website and sent to the
committee members three to four weeks before the meeting. The public can
request that part or all their comments not be published. The meeting minutes
are published on Medsafe’s website and the public again are given 10 days to
object to a recommendation.