Translation of "rapport signal direct signal réfléchi " (French → English) :

In accordance with Article 12, this report should consider any amendment to the Directive that would appear to be appropriate.

(1a) facilitate direct patient reporting through the provision of alternative reporting formats in addition to web-based formats;

(1b) facilitate direct patient reporting, in addition to web-based formats, through the provision on the patient information leaflet of a detachable portion that can be reported to the doctors, pharmacists or the national competent authority;

As a result of the submission of all suspected adverse reaction data directly to the Eudravigilance database, it is appropriate to amend the scope of periodic safety update reports so that they present an analysis of the risk-benefit balance of a medicinal product rather than a detailed listing of individual case reports already submitted to the Eudravigilance database.

Member States reported that shipments and exports are supervised and controlled in accordance with the procedures and provisions laid down in the Shipments Directive.

According to Directive 1999/30/EC, provisions on reporting under Council Directive 80/779/EEC on air quality limit values and guide values for sulphur dioxide and suspended particulates ,Council Directive 82/884/EEC of 3 December 1982 on a limit value for lead in the air and Council Directive 85/203/EEC of 7 March 1982 on air quality standards for nitrogen dioxide are repealed with effect from 19 July 2001, although the limit values under these Directives remain in force until 2005 for Directives 80/779/EEC and 82/884/EEC, and 2010 for Directive 85/203/EEC and reporting on exceedences of these limit values continues according to Article ...[+++]9(6) of Directive 1999/30/EC.