Speaker Interview >
Spanish Agency of Medical &
Health Products (AEMPS)
Head of Pharmaceutical Dept.
How have the latest GDP
Guidelines impacted the efforts to
prevent falsified medicines?
The new EU GDP guidelines came
into force in September 2013, so
the impact is still unknown but they aim to reinforce the
supply chain and avoid the entry of falsified medicinal
products in the legal supply chain
What type of changes were made with respect to “risk
assessment”?
Risk assessment (ICH Q9) is introduced as a tool to be used in
many of the activities to be performed.
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What are the biggest challenges that wholesalers will face
due to the new GDP?
The adequate implementation of risk management, the
qualification of suppliers and customers and the transport
aspects, specially ‘last mille transportation’
In your opinion, what type of changes are still needed to
improve the EU GDP?
Training of the wholesalers personnel is a key issue, the
adequate evaluation of companies with whom activities are
contracted and the qualification of suppliers and customers
In general, do you think more effort should be made to unify
US, EU and other Internal GDP Guidelines?
Absolutely, there is a global supply chain for medicinal
products and the GDP requirements should be very similar all
over the world.