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As regards the question of whether the infringement by the Commission of the conditions for withdrawal of a marketing authorisation set out in Article 11 of Directive 65/65 constitutes a sufficiently serious breach of a rule of law intended to confer rights on individuals, the General Court held in paragraphs 104 to 112 of the contested judgment that: ‘104 It follows that, in the present case, the Commission did not, in any event, in that specific context, have any discretion in the application of the substantive criteria for the suspension or withdrawal of a marketing authorisation laid down by Article 11 of Directive 65/65. 105 However, contrary to the applicant’s assertions, that fact alone is not sufficient for a finding that the infringement of Article 11 of Directive 65/65 is sufficiently serious to cause the Community to incur liability. As already stated …, the Community judicature must also take into consideration, inter alia, the legal and factual complexity of the situation to be regulated. 106 In this case, it must be observed that the general principle that precedence must be given to the protection of public health, given concrete expression in the substantive provisions of Directive 65/65, gives rise to specific constraints for the competent authority in the context of the grant and management of marketing authorisations for medicinal products. It requires, first, that the competent authority take account exclusively of considerations relating to the protection of public health, second, the re-evaluation of the benefit/risk balance of a medicinal product where new data give[s] rise to doubts as to its efficacy or safety and, third, the application of rules of evidence in accordance with the precautionary principle (Artegodan v Commission paragraph 174). 107 In this case, it is therefore for the General Court to examine the legal and factual complexity of the situation, taking account, in particular, of the pre-eminence of the public health objectives pursued, in order to establish whether the error of law made by the Commission is an irregularity which would not have been made by an administration exercising ordinary care and diligence in similar circumstances … 108 In that context, although the infringement of Article 11 of Directive 65/65 is clearly established and justified the annulment of the [contested decision], it is necessary to take into account the particular difficulties to which the interpretation and application of that article give rise in this case. Having regard to the lack of precision of Article 11 of Directive 65/65, the difficulties related to the systematic interpretation of the conditions for withdrawal or suspension of a marketing authorisation laid down by that article in the light of the whole Community system for the prior authorisation of medicinal products (Artegodan v Commission paragraphs 187 to 195) could reasonably explain, in the absence of any similar precedent, the error of law committed by the Commission in accepting the legal relevance of the new scientific criterion applied by the CPMP, even though it was not supported by any new scientific data or information. 109 Furthermore, in any event, account must also be taken of the complexity in this case of the examination of the reasoning of the final opinion on which the [contested decision] is based, which the Commission must undertake in order to be able to ascertain the existence of a connection between the application of the new scientific criterion and the guidelines on which the CPMP based its decision to justify that application. 110 The findings relating to the absence of proof in the CPMP’s Note for Guidance and the national guidelines of the alleged change in the abovementioned scientific criterion … could be made by the Commission only on the basis of a complex examination of successive draft scientific reports prepared in the course of the examination procedure which led to the final opinion on amfepramone, and the guidelines mentioned in that final opinion … 111 In that connection, it must be held that, having regard, first, to the complexity of the legal and factual assessments required for the application of Article 11 of Directive 65/65 in the circumstances of the case, and in the absence of any similar precedent, and, second, to the principle that precedence must be given to the requirements related to the protection of public health, the infringement by the Commission of Article 11 of Directive 65/65 was explained by the particular constraints to which that institution was subject in the pursuit of the fundamental objective of protecting public health, referred to by Directive 65/65. 112 In those circumstances, the infringement, in the present case, of Article 11 of Directive 65/65 cannot be regarded as a sufficiently serious breach of Community law of such a kind as to cause the Community to incur non-contractual liability.’