L 189/112 Official Journal of the European Union 27.6.2014 REGULATION (EU) No 658/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (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 point (c) of Article 168(4) 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), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The revenue of the European Medicines Agency (the ‘Agency’) consists of a contribution from the Union and fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services as referred to in Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (%). (2)  The provisions on pharmacovigilance relating to medicinal products for human use (‘medicinal products’) laid down in Regulation (EC) No 726/2004 and in Directive 2001/83/EC of the European Parliament and of the Council (*) were amended by Directive 2010/84/EU of the European Parliament and of the Council (°), Regulation (EU) No 1235/2010 of the European Parliament and of the Council (°), Directive 2012/26/EU of the European Parliament and of the Council (7) and Regulation (EU) No 1027/2012 of the European Parliament and of the Council (%). Those amendments provide for new pharmacovigilance tasks for the Agency, including pharmaco- vigilance procedures carried out at Union level, the monitoring of literature cases and the improved use of information technology tools. Furthermore, those amendments provide that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders. New types of fees should therefore be created to cover the new and specific tasks of the Agency. () OJ C 67, 6.3.2014, p. 92. (?) Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and decision of the Council of 8 May 2014. (®) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (O] L 136, 30.4.2004, p. 1). () Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (O] L 311, 28.11.2001, p. 67). (°) Directive 2010/84[EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmaco- vigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (O] L 348, 31.12.2010, p. 74). (%) 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 (O] L 348, 31.12.2010, p. 1). () Directive 2012/26[EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (O] L 299, 27.10.2012, p. 1). (%) Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (O] L 316, 14.11.2012, p. 38).