Spanish Medicines Agency updates national electronic submission guidance

The Spanish Medicines Agency "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" has released an updated version 2.2 of their national electronic submission guidance "ENVÍO POR PARTE DE LOS LABORATORIOS DE INFORMACIÓN EN FORMATO ELECTRÓNICO A LA AEMPS".

The new version puts more emphasize on the possibility to switch dossier formats. The general schedule only allows to switch from paper -> NeeS -> eCTD  or directly from paper -> eCTD but not backwards. Exceptions may be allowed in very rare cases that need to be duly justified (e.g. change of ownership etc.).

Furthermore the possibility to provide information outside the eCTD lifecycle or outside the NeeS format for MRP/DCP applications in justified cases has been included (e.g. national translations of Product Information).

The new version 2.2 of the electronic submission guidance is available for PDF download from the AEMPS website.

[Source: AEMPS]

<- Back to: News