10.4.2014 Official Journal of the European Union L 107/1 II (Non-legislative acts) REGULATIONS COMMISSION DELEGATED REGULATION (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to 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 ('), and in particular Article 22b thereof, Having regard to 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 veter- inary use and establishing a European Medicines Agency (%), and in particular Article 10b thereof, Whereas: (1)  Authorisation decisions for medicinal products should be made on the basis of the objective criteria of quality, safety and efficacy of the medicinal product concerned, to ensure that only high quality medicinal products are placed on the market and administered to patients. As a consequence, new medicinal products have to undergo extensive studies, including clinical efficacy trials, before they are authorised. (2)  According to Article 21a(f) of Directive 2001/83/EC and to Article 9(4)(cc) of Regulation (EC) No 726/2004 it may be necessary in specific situations to complement the data available at the time of authorisation with addi- tional information concerning the efficacy of a medicinal product, to address concerns that could not be resolved prior to the granting of the marketing authorisation. Moreover, according to Article 22a(1)(b) of Directive 2001/83/EC and to Article 10a(1)(b) of Regulation (EC) No 726/2004 post-authorisation information may require significant revision of previous efficacy evaluations and call for additional, confirmatory efficacy data, while the marketing authorisation is maintained. In both situations, the national competent authorities, the Euro- pean Medicines Agency and the Commission (hereinafter ‘the competent authorities’) may oblige the marketing authorisation holder to conduct a post-authorisation efficacy study. (3)  The obligation to conduct a post-authorisation efficacy study should address certain well-reasoned scientific concerns, which could have a direct impact on the maintenance of the marketing authorisation. It should not be used as a justification for the premature granting of a marketing authorisation. According to Article 22a(1) of () OJL311,28.11.2001,p. 67. () OJL136,30.4.2004,p. 1.