42It is apparent from the preamble to Regulation No 726/2004 (see in particular recital 19) that the centralised procedure for the authorisation of medicinal products provided for in that regulation is based on a scientific evaluation procedure being conducted by the EMA, which is to apply the highest possible standards, to address the quality, safety and efficacy of medicinal products. One of the main objectives of the authorisation regime provided for in that legislation is to ensure that patients are not administered medicinal products with a negative risk-benefit balance. In that respect, in accordance with Article 6(1) of 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 (OJ 2001 L 311, p. 67), as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ 2012 L 299, p. 1) ‘no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with [that] Directive or an authorisation has been granted in accordance with Regulation … No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [(OJ 2006 L 378, p. 1)]’.