Labelling changes
November 13, 2015
The Therapeutic Goods
Administration is proposing to
register an updated edition of the
Medicines Advisory Statements
Specification in one month’s time.
The updated edition of the MASS
will be titled Medicines Advisory
Statements Specification 2016
(MASS 2016) which will commence
on 01 Jan 2016 (PD yesterday).
It will contain a new version of the
Required Advisory Statements for
Medicines Labels (RASML), titled
RASML No. 3.
The MASS 2016 will allow for an
18-month transition period for
adoption of the new and amended
advisory statements in RASML No.
3 onto medicine labels.
Changes will include new and
amended statements that were
the subject of either public
consultation or a new Condition of
Listing between Jan 2014 and Oct
2015, including the consultation
on NSAIDs which ruled that an
additional advisory statement be
included to the effect that excessive
or prolonged use can increase the
risk of heart attack, stroke or liver
damage.
Other items subject to
changes include cimetidine,
famotidine, nizatidine, ranitidine,
esomeprazole, metoclopramide,
chloramphenicol and propamidine
as well as OTC nasal decongestant
preparations for topical use and
OTC cough medicines for oral use -
for details see tga.gov.au.
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