Safety of medicines is a core responsibility of the
manufacturers and distributors of medicines. The
responsibility is shared with the Pharmacy and Poisons
Recognizing that information obtained prior to first
marketing is often inadequate to cover all aspects of drug
safety and that tests in animals are at times insufficiently
predictive of human safety; and taking into consideration
that clinical trials may not completely replicate what
happens in clinical practice, it is prudently expected that
more information about rare but serious adverse reactions,
chronic toxicity, use in special groups (such as children, the
elderly or pregnant women) or drug interactions may
emerge regarding drugs which are already authorized for
use. These, combined with the fact that defects may emerge
during manufacture or storage of the products make it
necessary for stakeholders to be prepared to conduct
product recall or withdrawal if and whenever need arises.
These guidelines have been prepared to assist stakeholders
in dealing with such issues and define how the Pharmacy
and Poisons Board would manage such eventualities as
well as the role of the affected companies.
I trust that the cooperation and timely action by
stakeholders, in this regard, will go a long way in
upholding safety of medicines at all times.