Latest news MB treated plasma situation in France

Further to the last official communication from the French Drug and Medical Device Regulatory Agency (Afssaps) dated October 12th, 2011, Afssaps has decided to withdraw MB plasma from the list of approved blood products in France from March 1st, 2012.

Macopharma has instituted proceedings against Afssaps’ decision before the administrative French Supreme Court as following:

  • Summary proceedings aiming at the “suspension” of Afssaps’ decision which is an emergency procedure with a quick order (8 days time period) ;
  • Application for judicial review of administrative action for the cancellation of Afssaps’ decision to withdraw MB plasma from the French market because of a serious manifest error of evaluation : long procedure (around 12 month time period ).

Summary hearing has taken place before the Supreme Court on April 2, 2012 and the decision of the judge has been released on April 10, 2012 with the following conclusion:

The suspension of Afssaps’ decision has been rejected due to the following reasons:

  • Afssaps’ decision has been considered as legal,
  • The economical impact on Macopharma has not been considered as an important and urgent case,

Nevertheless, Macopharma will continue to dispute, claim and to bring more scientific evidences for the Application for judicial review of administrative action (cancellation of Afssaps’ decision) which is currently in progress.

In the meanwhile, Macopharma would like to inform you that new scientific literature, publications and oral presentations related to allergies and fibrinogen will be presented during the next IHN congress (International Haemovigilance Congress) in Montreal (Canada), the next IPFA/PEI congress in Budapest (Hungary) and the next ISBT congress in Cancun (Mexico).

We remain at your disposal for any questions you may have at this stage related to the content of this information.

The contact persons are:

 

 

FAQ-01

(October 2011)

 

 

FAQ-02

(January 2013)

 

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