Text tabled : A7-0165/2012

  Françoise Castex (S&D), in writing. – (FR) We must detect, assess and prevent the undesirable effects of medicines that are put on the market in the European Union, and we must do so at European level. Following the Mediator affair, the Commission implemented a ‘stress test’ which allowed us to identify weaknesses in current legislation. The present revisions are the result of this process. The improvements made today are numerous: most notably, the introduction of an automatic urgent procedure, the creation of a new trigger mechanism for the urgent procedure and the clarification of the transparency obligation of companies. The European regulation marks a significant step towards increased health security for Europeans, and we welcome that.