Last news 2013

Last update: 22nd July 2013

Archive

July 2013

Date Document title Publicado en:
22nd July 2013 Voluntary harmonisation procedure: pilot study to include the opinion of the Ethics Committee in the clinical trial assessment result
Information note MUH, 12_vi /2013
The AEMPS informs
Information notes
Medicines for
human use
Clinical research

May 2013

Date Document title Publicado en:
30th May 2013 Guideline for the nomenclature of cell therapy investigational medicinal products’ active substances Clinical
research

Clinical research
with medicines

March 2013

Date Document title Publicado en:
12th March 2013 The Spanish Agency of Medicines and Medical Devices sets up a new software application that allows marketing authorization holders the telematic management of Summary of Product Characteristics and Patient Information Leaflets
Information note MUH, 2_vi/2013
The AEMPS informs
Information notes
Industry

February 2013

Date Document title Publicado en:
22nd February 2013 Submission of the development safety update report (DSUR) to the AEMPS via the portal ECM and non acceptance of compressed files
Information note MUH, 01_vi /2013
The AEMPS informs
Information notes
The AEMPS

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