Review planned for warnings on medicines
Warnings used on medicines labels are likely to be overhauled, according to the latest report
from the Better Regulation of Medicines Initiative (BROMI).
The third report from BROMI (a group set up to look at ways of simplifying
and speeding up the system of medicines regulation and which includes
health professionals and representatives from the pharmaceutical industry
and the Medicines and Healthcare products Regulatory Agency) reveals
that it wants to review, update and improve statutory label warnings.
“These warnings have been required since the late 1970s and there
is an increasing body of evidence that some revisions to the warnings
may be
beneficial for patient understanding,” the report says.
The report also highlights some of BROMI’s successes since it was
set up in 2005. These include a new self-certification system for minor
changes to patient information (such as changes to the shape of labels
on medicine bottles), which BROMI says has not had a serious impact on
public health.
A new code of practice around the re-design of non-statutory packaging
information means that the time taken by the MHRA to approve minor changes
has been reduced from 90 to 30 days.
|
The
Pharmaceutical Journal
Acrobat
Reader