MHRA acts to define “fast-acting” and “24-hour relief” claims for advertisements
Concern over what is meant by “fast-acting” and “24-hour relief” have led the MHRA to issue guidance on what it considers to be acceptable claims and the supporting evidence needed to justify them.
Companies wishing to include the claims in their product advertising
or on medicine packs will need to produce clinical evidence for each
indication or symptom for which the claim is made, says the Medicines
and Healthcare products Regulatory Agency. Evidence of effective blood
levels alone is unlikely to be acceptable.
Claims for fast action should only be made for conditions where speed
of onset is relevant, such as acute pain relief or hay fever, and not
in relation to chronic conditions or those not requiring immediate relief.
Although the period within which clinical effectiveness must be achieved
can vary according to the indication, a rule of thumb suggested by the
MHRA is that onset of relief is expected within 30 minutes for hay fever
preparations.
Claims for 24-hour relief need to be supported by evidence of clinical
effectiveness over a full 24-hour period. Such claims are only acceptable
for products with once-daily dosing, the MHRA suggests, adding that a
once-daily dosing interval alone will be insufficient to justify 24-hour
relief claims.
In both cases, claims can only be included on labels when supported by
SPCs. |
The
Pharmaceutical Journal