The Spanish Agency of Medicines and Medical Devices
has set up a new online software tool that allows marketing authorization holders the
telematic management of Summary of Product Characteristics (SmPCs) and Patient
Information Leaflets (PILs).
This new software tool involves the presentation of SmPC/PIL
texts separated into sections.
The separation of the product texts into sections will help speed up the
process of evaluation, both in new approvals and in variations, as it will
allow focusing on the content to be changed.
During the first phase started in 2013, it was mandatory to submit the
separated SmPC/PIL texts through this new software tool for all new
marketing authorization as well as variations requesting a new SmPC.
As of November 14th 2013, the second phase of the project has started
and this new procedure is now also mandatory for any kind
of variation that modifies these documents.
Companies are encouraged by the AEMPS to use this system via the RAEFAR portal in
order to speed up the process of approval of New Applications and Variations.
The system can only be accessed from the RAEFAR portal, which makes it necessary
for foreign companies to have a local contact in Spain.
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