27.10.2012 Official Journal of the European Union L 299/1 | (Legislative acts) DIRECTIVES DIRECTIVE 2012/26/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE (2)  In addition, voluntary action by the marketing authori- EUROPEAN UNION, sation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly Having regard to the Treaty on the Functioning of the European address-ed in 31.1 .Member States. Therefor.e, the Union, and in particular Article 114 and Article 168(4)(c) marketing authorisation holder should be obliged to thereof, inform the relevant competent authorities and the European Medicines Agency of the reasons for with- drawing or interrupting the placing on the market of a Having regard to the proposal from the European Commission, mf-:dlc.lnal product, for requesting that .market1ng aut h- orisation be revoked, or for not renewing a marketing authorisation. After transmission of the draft legislative act to the national parliaments, (3) It is appropriate to further clarify and strengthen the Normal Procedure and the Urgent Union Procedure in Having regard to the opinion of the European Economic and order to ensure coordination, swift assessment in case of Social Committee (1), urgency and the possibility to take immediate action, where necessary to protect public health, before a decision is taken at Union level. The Normal Procedure After consulting the Committee of the Regions, shoulq be initiated.f(.)r matters concerning qufﬂity, safety or efficacy of medicinal products where the interests of the Union are involved. The Urgent Union Procedure o ) ) o s should be initiated when there is a need to swiftly Acting in accordance with the ordinary legislative procedure (3), assess concerns resulting from the evaluation of data from  pharmacovigilance activities. Regardless of whether the Urgent Union Procedure or the Normal Whereas: Procedure is applied, and regardless of the procedure by means of which the medicinal product was auth- orised, be it centralised or otherwise, the Pharmaco- (1) Recent pharmacovigilance incidents in the Union have vigilance Risk Assessment Committee should always shown the need for an automatic procedure at Union give its recommendation when the reason for taking level in cases of specific safety issues to ensure that a action is based on pharmacovigilance data. It is appro- matter is assessed and addressed in all Member States priate that the coordination group and the Committee where the medicinal product is authorised. The scope for Medicinal Products for Human Use rely on that of different Union procedures concerning products auth- recommendation when carrying out the assessment of orised at national level, as laid down in Directive the issue. 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 (*), should . . . be clarified. 4) It is appropriate that Member States bring cases () OJ C 181, 21.6.2012, p. 201. (3) Position of the European Parliament of 11 September 2012 (not yet published in the Official Journal) and decision of the Council of 4 October 2012. () OJ L 311, 28.11.2001, p. 67. concerning new contraindications, reductions in the recommended dose or restrictions to the indication for medicinal products authorised in accordance with the decentralised procedure and the mutual recognition procedure to the attention of the coordination group when the Urgent Union Procedure is not initiated. In