Traduction de «Résumé médical de la mise à jour des RMAC » (Français → Anglais) :

Update of the contents of the summary of results and summary for laypersons

1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals, hospitals and patients, marketing authorisation holders and medication error reporting and prevention programmes, specifying whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics.

2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database, specifying whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics.

1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, specifying whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post-authorisation safety study.

In the case of an update concerning study summaries or robust study summaries, the Agency shall levy a fee for each study summary or robust study summary for which the update is made.

The Commission should be empowered to adopt the measures necessary for the implementation of Directive 2004/109/EC in order to clarify the technical aspects of some of the definitions provided under that Directive, notably the maximum length of the usual short settlement cycle, the calendar of trading days, the circumstances under which a person should have learnt of the acquisition or disposal of voting rights, the conditions of independence to be respected by market makers and management companies; take account of technical developments in financial markets; clarify the nature of the auditor’s review, to define the minimum content of ...[+++] the condensed set of solo financial statements; elaborate further the procedures for the notification and disclosure of major holdings as well as the procedures for filing regulated information with the competent authority of the issuer’s home Member State; and define minimum standards for the dissemination of regulated information and for the setting up of storage mechanisms.