French Health Products Safety Agency

Main english documents available on Afssaps  web site

Documents
   
  Reports


2001Annual Report - Haemovigilance Unit 904 ko (april/2003)
Because of its weight the document is divided in 5 parts
  chapter 1 256ko chapter 2 211ko chapter 3 224ko chapter 5-6 117ko


Serious adverse events encountered in the gene transfer clinical trial for X-linked severe combined immunodeficiency disease X-SCID (feb/2003)
Temporary Authorisations for Use (ATU)   97ko (feb/2002)


Report on the evaluation of endovascular protheses used for the repair of infrarenal abdominal aortic aneurysms .   107ko (july/2001)


Risk analysis of new variant Creutzfeldt-Jakob disease transmission by blood and blood products 116ko (dec/2000)

Revision of measures to minimising the risk of TSE transmission via blood products  86ko (feb/2000)
Prasterone-DHEA - monograph : french pharmacopoeia 
 
Biologist information
Revaluation of the analytical sensitivity of the free beta subunit of hCG reagents
 
Forms
Free sale certificate pdf format rich text format
Medicinal product certificate 60ko (april/2003)


Medical devices with a high potential of risks for human health -directions for use
(april/2003)


Notice to applicants for marketing authorisations of medicinal products for human use 113ko (jan/2003) (rich text format)
Export Statement 28k (march/2003)
Certificate of good manufacturing practice 28k (sept/2001)
   

The Agency

   
 
   

Press releases

   
  Severe Combinated immuni-Deficiency
(jan/15/2003)
 
Severe Combined Immuno-Deficiency.  Clinical trial put on hold
 (oct/03/2002)
   

Database (in french)