Brussels, 08/10/2012 (Agence Europe) - On 4 October, the Council of Ministers adopted without debate, new rules on pharmacovigilance (a regulation and a directive) as a means to improve patient safety. This adoption follows a first reading agreement with the European Parliament on 12 September last (EUROPE 10687). New rules will strengthen the provisions adopted by the Council on 29 November 2010, following the mediator scandal, which exposed shortcomings in the revised legislation in 2011. An important Council objective was to ensure that new provisions allowed for the rapid detection of potentially dangerous medicines and prevent undesirable effects going unnoticed due to there being too much information. The new regulation and directive will enter into force at the end of 2013. The European Commission explained that, “no product will fall through the net and escape meticulous examination when a safety concern has been identified”. The latter was extremely pleased that consensus had swiftly been reached between the European institutions. (IL/trans/fl)