The
SPC contains the information about a product.
To
give a few examples, the SPC gives:
·
the name of
the product, what
medicine it contains (its active substance), what
animal species it can be administered to, what
diseases it can be used to treat (or, in the case of vaccines what diseases it
prevents), what
its shelf life is.
It
also gives safety warnings. These include:
· warnings
about the product's use, for both the person administering the product and for
the animal(s) the product is being administered to, information
about the safe disposal of the product and its packaging, to ensure safety to
protect the environment.
In
the case of food producing animals, the SPC also gives withdrawal periods, i.e.
how long after the product has been administered can the meat, milk, eggs etc.
from that animal be consumed.
The SPC is approved as part of the authorisation process for a
product and forms part of the Marketing Authorisation. It cannot be changed by
the Marketing Authorisation Holder without approval.