How to Monitor new medicines and vaccines- MHRA
New
chemicals and vaccines are effectively put on probation for up to two
years and labelled with a black triangle to ensure prescribers are aware
of the need to monitor them carefully. The black triangle symbol
accompanies new medicines and vaccines in prescribing manuals, product
information, and advertising material. It prompts healthcare
professionals to report any potential side effects to the MHRA. This
information helps to build up a broader picture of how the treatment
works in the general population and enables the MHRA to act promptly,
should a previously unrecognised and serious side effect come to light.
The black triangle may also be assigned to a medicine that has already
been licensed if it contains a new combination of active chemicals or if
it is being used in a new way or for a different condition. The black
triangle is not removed until the MHRA is satisfied that the medicine
works safely in large numbers of people. Additionally, the MHRA also
asks manufacturers to keep a close watch on side effects that may be
associated with newly marketed products.
Source: MHRA Guidelines
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