Judgment — ECLI:EU:T:2002:307
Date: 2002-12-10
Language of the case: English
Court formation: Fifth Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Measures having equivalent effect;Approximation of laws;Quantitative restrictions
Concepts: Statement of reasons;General
Procedure: Action for annulment - successful
Origin: Germany

summary of product characteristics, a single leaflet and a single label approved. It is advisable for applicants using the centralised procedure to identify at an early stage, and before lodging the application, one brand name which can be used throughout the Community while keeping fall-back options (brand name(s)) in reserve. However, in exceptional cases, in particular where the proposed brand name has been cancelled, opposed or objected to under trade mark law in a Member State, the Commission will address the issue in order not to disadvantage patients and their access to the concerned medicinal product in that Member State. If sufficient evidence is given by the marketing authorisation holder that, in spite of all its efforts, the chosen or foreseen trade mark cannot be used in a Member State, the Commission will - exceptionally - authorise the use of a different trade mark in that Member State. Should a derogation be granted, it will affect neither the legal obligations of the marketing authorisation holder, nor the validity of the marketing authorisation throughout the Community. 76. That exception, the basis for which is public health protection, is consonant with the interpretation of Regulation No 2309/93 set out above (see paragraphs 63 to 74 above). 77. The Court finds that in the contested decision the EMEA did not adopt the interpretation set out in the Communication of 22 July 1998 and did not consider whether the applicant could rely on exceptional circumstances such as to justify the addition of names in respect of the medicinal product Daquiran. By contrast, the EMEA relied on another interpretative publication from the Commission, namely the Guideline on dossier requirements for Type I variations (November 1999). That document is intended to provide applicants for minor variations to a Community MA with clarification of a practical nature. Following an introductory section, the document is presented as a table which sets out, for 34 kinds of variations, the conditions to be met and the documents which the applicant must provide. The name is one of the terms of the MA which may be varied only by substitution. By implication, the guideline rules out the possibility of variation of a Community MA consisting of the addition of a name. That interpretation is thus inconsistent with the Communication of 22 July 1998, although there was no suggestion that the guideline was intended to amend the communication. That inconsistency is regrettable from the point of view of legal certainty, since the Communication of 22 July 1998 and the guideline at issue both seek to interpret Regulations No 2309/93 and No 542/95. 78. Third, it is necessary to add that it is apparent from the Commission's practice in taking decisions that on at least two occasions the Commission authorised a variation of a Community MA consisting of the addition of a name (medicinal products Refludin and Refludan; Infergen and Inferax). 79. The Court must therefore conclude from the foregoing that the contested decision, in so far as it rejects an application to vary a Community MA by adding two names on the sole ground that a medicinal product may never have more than one name, is based on an incorrect interpretation of Regulations No 2309/93 and No 542/95. In the absence of any provision specifically prohibiting such a variation, the Commission may authorise the adding of a name to a Community MA where the holder of the Community MA shows that exceptional circumstances which may adversely affect public health so require and that the variation applied for satisfies the criteria of the quality, safety and efficacy of the medicinal product. 80. Finally, the Court must address the Commission's arguments. The Commission, having acknowledged in its pleadings that the requirement for a single name may be waived in exceptional circumstances, argued that the applicant had not shown that such circumstances existed in this instance (see paragraphs 58 and 59 above). That argument cannot be accepted. In the contested decision, the EMEA did not determine whether the circumstances mentioned by the applicant (opposition in respect of use of the trade mark DAQUIRAN and availability of the marks FIROL and SIPNOK) were exceptional so as to allow its application to be granted. The interpretation of the applicable legislation just examined by the Court was all that the EMEA gave the applicant by way of explanation for its refusal. 81. Since a decision must be self-sufficient, the reasons on which it is based may not be stated in written or oral explanations given subsequently when the decision is already the subject of proceedings brought before the Community judicature (Case T-16/91 Rendo and Others v Commission [1996] ECR II-1827, paragraph 45). In such a situation, the Commission cannot now argue that the circumstances cited by the applicant were not exceptional. If such reasons were capable of proving decisive, it was for the EMEA to explain them to the applicant in the contested decision, in accordance with the obligation to state reasons deriving from Article 5(4) of Regulation No 542/95 and Article 67 of Regulation No 2309/93, pursuant to which all decisions to grant, refuse, vary, suspend, withdraw or revoke a marketing authorisation which are taken in accordance with this Regulation shall state in detail the reasons on which they are based. 82. Furthermore, it is not for the Court to substitute itself for the Commission or the EMEA and consider of its own motion whether, in the present case, there are exceptional circumstances such as to enable the application for variation of the name of the medicinal product Daquiran to be granted. 83. Therefore, the contested decision must be annulled in so far as it rejects the application for a variation of a Community MA concerning the name of the medicinal product and it is not necessary to consider the other pleas in law which relate to that aspect of the contested decision. The requirement for a single package layout 84. The applicant claims that the requirement in the contested decision for a single package layout has no legal basis. 85. It observes that the contested decision is founded solely on the Guideline on packaging information of medicinal products for human use authorised by the Community (April 1999). Since the reasoning on which a measure is based must be self-sufficient, the Commission cannot invoke in these proceedings reasons deriving from Directives 65/65 and 92/27 (Case T-77/95 Ufex and Others v Commission [2000] ECR II-2167, paragraph 54). 86. In its Notice to Applicants, the Commission itself stated that the Guideline has no legal force and does not necessarily represent its definitive view. It also added that, in case of doubt, reference should be made to the appropriate Community directives and regulations. 87. In case the Court should find that the Guideline does have legal force, the applicant raises a plea of illegality, challenging the legality of the condition relating to the requirement for a single package layout on the ground that it is not founded on any provision of the relevant legislation. Directive 92/27, in particular Article 2(2) thereof, does not require the use of a single package layout for a medicinal product marketed in several Member States. Before introduction of the centralised procedure, the objective of that directive was to approximate the legislation of the Member States on the labelling of medicinal products and on package leaflets. In such circumstances, there are no grounds for concluding from Directive 92/27 that Community MAs are restricted to medicinal products whose package layout is the same in all Member States. 88. Finally, the applicant asserts that the requirement is at variance with the EMEA's practice with regard to parallel distributors. The EMEA has already allowed the medicinal product Zyprexa to be marketed under a Community MA with different package layouts, following the repackaging of the product by Eurim Pharm. 89. The applicant repeats the argument that a Community MA cannot be refused or withdrawn unless there are overriding requirements relating to the protection of public health. The requirement for a single package layout cannot be justified on grounds relating to the free movement of goods (Articles 3 EC and 28 EC). Thus, the Commission could withdraw or refuse to grant an MA where, owing to specific circumstances, the use of different package layouts entailed a risk for public health because of, for example, language differences or a risk of confusion between several medicinal products. The Commission cannot plead protection of public health as a ground for systematically requiring use of a single package layout. Many products are currently marketed under different package layouts in the various Member States without any particular risk of confusion. 90. In this instance, the Commission has not claimed that there are any specific circumstances such as to put public health at risk. The applicant concludes that the requirement for a single package infringes the principle of proportionality. 91. The Commission refutes those arguments. It contends that Article 9(1) of Regulation No 2309/93 refers to the provisions of Directive 92/27. Those provisions form the basis for the reasoning in the Guideline to which the contested decision refers. According to the Guideline, the logo, format, layout, style, colour scheme and pack dimensions must be identical for all the versions of the packs of that medicinal product throughout the Community. 92. Therefore the text of the label and the package leaflet form part of the Community MA and must be identical throughout the Community. The only exceptions to that rule concern the language used on the label (Article 4 of Directive 92/27) and the requirements which Member States may continue to make concerning indications of price or of reimbursement conditions by social security organisations (Article 5(2) of Directive 92/27). 93. The Commission points out that the applicant gave no reasons for its application for a different trade dress in Germany. In its correspondence with the EMEA, the applicant confined itself to putting forward commercial reasons. 94. As regards the applicant's criticisms based on the situation of parallel importers (see paragraph 88 above), the Commission denies that its practice has been inconsistent. It refers to its Communication of 22 July 1998 and states that a Community MA encompasses all language versions of the labelling and package leaflet and all available authorised pack sizes. The original condition of the product inside the packaging must never be directly or indirectly altered. Any changes in the size of the package must be duly justified. It is incumbent on parallel importers to prove that it is strictly necessary to make such changes. The Commission's practice is logical, consistent and founded in law. 95. Finally, the Commission contends that the plea of illegality raised in relation to the Guideline is inadmissible. The plea of illegality, provided for in Article 241 EC, is available only in respect of acts of general scope which produce similar effects to those of a regulation (Case 92/78 Simmenthal v Commission [1979] ECR 777, paragraph 40). Since the Guideline is not a legally binding measure, Article 241 EC does not apply to it. The Commission adds, in the alternative, that the plea of illegality is unfounded, for the reasons set out above. 96. The applicant's reply to the Commission's acknowledgement that the Guideline is not legally binding is that the Commission has thereby confirmed that the Guideline cannot constitute a legal basis for the requirement relating to the use of a single package layout. The applicant declares that in those circumstances there is no longer a need for a plea of illegality against the Guideline. Findings of the Court 97. First, the Court must reject the applicant's argument that the contested decision has no legal basis because the Guideline on which it is founded is not legally binding. Admittedly, the EMEA decided the application relating to the package layout exclusively by reference to the Guideline. Not being binding, the Guideline explains, by way of guidance, the construction which the Commission intends to put on the applicable legislation. However, that fact is not such as to render the contested decision devoid of any legal basis or to provide grounds for its annulment. The EMEA gave direct application to the provisions of the Guideline concerning the interpretation of Directive 92/27, and the legality of that interpretation can thus be reviewed in an action brought against the contested decision (see, by analogy, Joined Cases 32/58 and 33/58 Snupat v High Authority [1959] ECR 127, at 141). 98. Second, it is appropriate to consider whether the contested decision is based on a correct interpretation of the applicable legislation. Referring solely to the Guideline, the contested decision confined itself to stating the presentations of a medicinal product (logo, format, layout, style, colour scheme and pack dimensions) must be identical throughout the Community and that the proposed specific package layout for the German market only could therefore not be accepted. 99. It is appropriate to bear in mind that Section D of the Guideline, which deals with presentation of the medicinal product, contains the following comments: 2. Pack design For practical and linguistic reasons holders of Community Marketing authorisations are likely to present medicinal product packaging in several linguistic and/or national versions ... In such cases, the logo, format, layout, style, colour scheme and pack dimensions must be identical for all the versions of packs of that medicinal product throughout the Community. In accordance with Article 10 of Directive 92/27/EEC, all proposed changes to any aspect of the presentation shall be submitted to the EMEA, who will inform the Commission. 100. In order to ascertain whether that interpretation is well founded, it is necessary, first, to point out that Regulation No 2309/93 does not specifically require use of a single package layout for a medicinal product with a Community MA. Under Articles 9 and 11 of Regulation No 2309/93, the package layout of a medicinal product in respect of which an application has been made for a Community MA must comply with the requirements of Directive 92/27. Article 2(1) of Directive 92/27 provides that the outer packaging of a medicinal product must contain certain compulsory particulars. Article 2(2) further provides that the outer packaging may include symbols or pictograms designed to clarify certain information mentioned in paragraph 1 and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature. Those provisions do not expressly deal with aspects of the package layout such as colour, logo, format and general layout. 101. However, considerations deriving from the unitary nature of the Community MA and the fundamental principle of the free movement of goods suggest that a medicinal product which is the subject of an application for a Community MA must, as a general rule, have a single package layout. That interpretation is consonant with the general scheme and purpose of the applicable legislation. In that regard, the Court must point out that it is not disputed that, as regards a national MA, a single package layout is authorised. In the present dispute, it is not for the Court to adjudicate on the circumstances in which third parties who, although they do not hold a Community MA for a medicinal product, are responsible for parallel distribution of the product may vary its package layout. 102. Finally, as regards the question whether that interpretation also precludes any application for variation of a Community MA, it is appropriate to point out that Regulation No 542/95, which specifically contemplates the possibility of a change of name, does not contain any comparable provision concerning the package layout. In the absence of any express provision, it is not possible to read into the silence of the legislature an intention on its part to prohibit any variation of that kind. 103. The package layout, like the name, is one of the formal aspects of a Community MA and has no direct bearing on the scientific properties of the medicinal product. Whilst the choice of name may have repercussions for public health owing to a risk of confusion with other medicinal products, it is unlikely - although not impossible - that such a risk may arise as a result of a variation of some of the aspects of the package layout of a medicinal product, such as the logo, colour, format and general layout. By contrast, rejecting any application for a variation of a Community MA consisting of the addition of a package layout may entail risks for public health. It is conceivable that, after a Community MA has been obtained, the holder of the authorisation may find that use of the package layout in the Community MA is prohibited in a Member State, for example on conclusion of an infringement action. In such a situation, to refuse an application to vary a Community MA would risk, at least until the grant of a new Community MA for another package layout, jeopardising patients' access in that Member State to the medicinal product concerned. 104. In rejecting the application for a variation of a Community MA consisting of the addition of a specific package layout for the German market without considering whether there were exceptional circumstances, the contested decision is based on an incorrect interpretation of the applicable legislation. In those circumstances, the Court must declare well founded the applicant's claim challenging the interpretation that the package layout of a medicinal product must, without exception, be the same throughout the Community. 105. It is not the Court's place to substitute itself for the Commission or the EMEA and to consider whether, in this instance, there are exceptional circumstances such as to enable the application for a variation of the package layout of the medicinal product Daquiran to be granted. 106. Therefore, the contested decision must be annulled in so far as it rejects the application for a variation of a Community MA concerning the package layout of the medicinal product concerned and it is not necessary to consider the other pleas in law which relate to that aspect of the contested decision. 107. Therefore the decision must be annulled in its entirety. Costs 108. Under Article 87(2) of the Rules of Procedure of the Court of First Instance, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. In this instance, since the Commission has been unsuccessful in its pleadings and the applicant and the EFPIA, intervener, have applied for costs, the Commission must be ordered to bear its own costs and to pay the costs of both the applicant and the EFPIA. 109. Under the first subparagraph of Article 87(4) of the Rules of Procedure of the Court of First Instance, the Council, intervener, is to bear its own costs. On those grounds, THE COURT OF FIRST INSTANCE (Fifth Chamber) hereby: 1. Annuls the decision of 1 March 2000 of the European Agency for the Evaluation of Medicinal Products, rejecting an application for variation of certain terms of the marketing authorisation for the medicinal product Daquiran; 2. Orders the Commission to bear its own costs and to pay the costs incurred by the applicant and the EFPIA, intervener; 3. Orders the Council to bear its own costs. Cooke García-Valdecasas Lindh Delivered in open court in Luxembourg on 10 December 2002. H. Jung R. García-Valdecasas Registrar President 1: Language of the case: English.