31.12.2010 Official Journal of the European Union L 348/1 (Legislative acts) | REGULATIONS REGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (3), Having regard to the opinion of the European Data Protection Supervisor (%), Acting in accordance with the ordinary legislative procedure (), Whereas: (1) Regulation (EC) No 726/2004 (°) creates a Union-wide marketing authorisation procedure for certain categories of medicinal products (the ‘centralised procedure), lays down rules for the pharmacovigilance of those products and establishes the European Medicines Agency (the ‘Agency). (2)  Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess () OJ C 306, 16.12.2009, p. 22. () O] C 79, 27.3.2010, p. 50. () O] C 229, 23.9.2009, p. 19. (*) Position of the European Parliament of 22 September 2010 (not yet published in the Official Journal) and Council Decision of 29 November 2010. () OJ L 136, 30.4.2004, p. 1. adverse reactions to medicinal products for human use placed on the Union market, as the full safety profile of medicinal products for human use can be known only after they have been placed on the market. The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem. Member States should consider measures to monitor and evaluate the risk of environmental effects of such medicinal products for human use, including those which may have an impact on public health. The Commission should, based, inter alia, on data received from the Agency, the European Environment Agency, and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to Union legislation on medicinal products for human use or other relevant Union legis- lation are required. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. The main tasks of the Agency in the area of phar- macovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Union pharmacovigilance database and data-processing network (the ‘Eudravigilance database’), the coordination of safety announcements by the Member States and the provision to the public of information regarding safety issues.