How does licensing and authorisation work?
Licences for medicines are granted only when a product meets high standards
of safety and quality and works for the purpose intended. The regulatory system
also imposes rigorous standards on medicines manufacturers and wholesale
dealers who trade in them.
The licensing system guarantees accountability
for all those involved and ensures that processes,
supplies, and quality can be thoroughly
monitored and swift corrective action taken
where necessary.
The authorisation process for devices differs
from that applied to medicines. However, once
marketed, safety and performance of medicines
and medical devices are monitored and
enforced in similar ways.