1 By order of 10 November 2000, received at the Court on 23 November 2000, the Landgericht Köln (Regional Court, Cologne) referred to the Court for a preliminary ruling under Article 234 EC two questions on the interpretation of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1) and of the rules of Community law on the free movement of medicinal products.
2 Those questions were raised in proceedings between Aventis Pharma Deutschland GmbH (`Aventis'), on the one hand, and Kohlpharma GmbH (`Kohlpharma') and MTK Pharma Vetriebs-GmbH (`MTK'), on the other, concerning the repackaging of medicinal products at the time of their parallel importation into Germany from other Member States. Legal context
3 With effect from 1 January 1995, Regulation No 2309/93 established a procedure for obtaining central marketing authorisations for medicinal products.
4 Article 6(1) of Regulation No 2309/93 provides: `An application for authorisation for a medicinal product for human use must be accompanied by the particulars and documents referred to in Articles 4 and 4a of Directive 65/65/EEC'.
5 Point 9 of the second paragraph of Article 4 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council Directive 83/570/EEC of 26 October 1983 (OJ 1983 L 332, p. 1) and Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11), requires that the application for authorisation be accompanied by `[a] summary, in accordance with Article 4a, of the product characteristics, one or more specimens or mock-ups of the sales presentation of the medicinal product, together with a package leaflet where one is to be enclosed'.
6 Under Article 9(3)(c) of Regulation No 2309/93, in the event of an opinion in favour of granting the relevant authorisation to place the medicinal product concerned on the market, the draft text of the labelling and package leaflet proposed by the applicant is to be annexed to the opinion. In addition, Article 10(1) of that regulation provides that that document is to be annexed to the draft decision, prepared by the Commission, in favour of granting the application for a marketing authorisation.
7 Pursuant to the second paragraph of Article 11 of Regulation No 2309/93, a central marketing authorisation is to be refused if the particulars and documents provided by the applicant in accordance with Article 6 of that regulation are incorrect or if the labelling and package leaflets proposed by the applicant are not in accordance with Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets (OJ 1992 L 113, p. 8).
8 Article 12(1) of Regulation No 2309/93 provides: `... a marketing authorisation which has been granted in accordance with the procedure laid down in this regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member State in accordance with Article 3 of Directive 65/65/EEC. The authorised medicinal products shall be entered in the Community Register of Medicinal Products and shall be given a number which must appear on the packaging.' The main proceedings and the questions referred
9 Aventis manufactures the medicinal product `Insuman Comb 25, 100 UI/ml, suspension injectable' (`Insuman') and holds, pursuant to Regulation No 2309/93, central marketing authorisations for packs containing 10 cartridges of 3 ml, under number EU 1/97/030/062, and for packs containing five cartridges of 3 ml, under number EU 1/97/030/045. It markets Insuman in Germany in packs of 10 cartridges.
10 Kohlpharma and MTK are parallel importers of medicinal products into Germany from other Member States. They import, inter alia, Insuman marketed in France by Aventis in packs of five cartridges. They repackage it into packs containing 10 cartridges and present these packs in the same way as those manufactured by Aventis for the marketing of Insuman in Germany.
11 Aventis considers that, for the purposes of marketing Insuman in Germany, Kohlpharma and MTK could produce multiple packages, that is to say, retail packs consisting of two imported five-cartridge packs, over-stickered as appropriate (`bundling'). The creation of new external packaging is therefore not `necessary' within the meaning of the case-law of the Court, in particular Case C-232/94 MPA Pharma [1996] ECR I-3671. In addition, according to Aventis, the repackaging in new 10-cartridge packs which is carried out by Kohlpharma and MTK infringes its trade mark rights.
12 Aventis applied to the Landgericht Köln for an order prohibiting Kohlpharma and MTK from importing and marketing Insuman in Germany for as long as they market it in new external packaging containing 10 cartridges.
13 Kohlpharma and MTK submitted that that application should be dismissed. They consider that, on a correct interpretation of the case-law of the Court, the creation of new external packaging is legally `necessary' in cases such as that at issue, since there is no requirement to give preference to bundling over repackaging in new external packaging. While it is admittedly true that, according to the case-law of the Court, relabelling is preferable to repackaging, since the effect of bundling is in any event to create new external packaging, the choice is not, in the main proceedings, between mere relabelling and repackaging. In addition, the central authorisation, which the defendants cannot influence, refers to very specific packages, as is apparent from the different authorisation numbers and as is confirmed by the opinion of the European Agency for the Evaluation of Medicinal Products (`the EMEA') which, in a letter of 30 May 2000 to Kohlpharma, stated that a multiple package of two sets of five cartridges is not covered by the central marketing authorisation for Insuman. In those circumstances, the creation of such a package is in any event not permissible.
14 The national court states that: - theoretically, if it were not for the exhaustion of the rights conferred by Community law and, in that connection, the need to establish and maintain the free movement of goods within the Community, Aventis, as owner of the Insuman trade mark, would be entitled, pursuant to the Markengesetz (German law on trade marks), to prohibit Kohlpharma and MTK from affixing that mark to the new external packaging of the Insuman imported by them from France; - on that basis, the parties are correctly in agreement that Kohlpharma and MTK are permitted, on grounds related to the free movement of goods as set out in the case-law of the Court, to overcome the obstacles to importation resulting from the difference in size of the packs sold in Germany and in France and that they are entitled to create packages of 10 cartridges out of imported packs of five cartridges; - the only matter in dispute is the manner in which those packages, which are larger than the original packs, may be created and, in particular, whether Kohlpharma and MTK are entitled to use new external packaging bearing the Insuman trade mark.
15 The national court takes the view that that question must receive an affirmative response in favour of Kohlpharma and MTK if the creation of a multiple package is to be regarded as no longer covered by the central marketing authorisation for Insuman. That interpretation of Community law can a fortiori not be dismissed since it is that propounded by the EMEA, even though its opinion is not legally binding.
16 In those circumstances, the Landgericht Köln decided to stay proceedings and to refer the following questions to the Court for a preliminary ruling: `(1) Do the provisions governing the central authorisation of medicinal products in the European Union - in particular those of Regulation (EEC) No 2309/93 - preclude the legal possibility of "bundling" (that is to say, the joining together of several packages, each bearing the necessary labelling, in order to form a new retail unit) of packages of medicinal products following importation into one Member State from another Member State, in such a way that "repackaging" of medicinal products (that is to say, the production of new external packaging to which the importer affixes the foreign trademark without the authorisation of the trademark holder) is "necessary" within the meaning of the decision of the European Court of Justice in Case C-232/94 MPA Pharma [1996] ECR I-3671 and the trademark holder for that reason cannot prohibit such repackaging? (2) In the event that Question 1 should be answered in the negative: Do the rules on the free movement of goods within the Common Market or other rules of Community law stand in the way of a prohibition which, in cases of the kind referred to in Question 1, is directed against "repackaging" on the ground, derived from national trademark law, that the possibility of creating a bundle package, which, moreover, exists de facto and de jure, constitutes a less intrusive interference with the rights of the trademark holder?' The first question
17 By its first question, the national court is essentially asking whether Regulation No 2309/93 precludes a medicinal product which is the subject of two separate central marketing authorisations, one for packs of five items and the other for packs of 10 items, from being marketed in a package consisting of two packs of five items which have been joined together and relabelled. Observations submitted to the Court
18 According to Aventis, Regulation No 2309/93 does not contain any provision capable of acting as the legal basis for a prohibition on bundling in circumstances such as those in question in the main proceedings. More generally, there is no reason for such a prohibition. The parallel importers should therefore use bundling, which is a less intrusive interference with the trade mark, rather than produce new external packaging.
19 Kohlpharma and MTK, the Norwegian Government and the Commission consider that Regulation No 2309/93 must be interpreted as meaning that a central authorisation issued in accordance with that regulation does not cover multiple packages.
20 The defendants in the main proceedings argue that the only way for them to gain effective access to the German market is therefore to produce new external packaging. By contrast, the Commission submits that, as a consequence of the grant of the central authorisations, a parallel importer is allowed to place on the market in Germany packs of five cartridges of Insuman which it has obtained in France - after affixing labels in German to ensure that they are comprehensible to German consumers - without altering the size and the form of their packaging, since the central authorisations issued for that medicinal product apply to all the Member States. It wonders, however, whether there are not other reasons for which relabelled packs of five cartridges may not be placed on the German market, so that effective access to that market should be regarded as hindered. Findings of the Court
21 In accordance with the second paragraph of Article 12(1) of Regulation No 2309/93, authorised medicinal products are to be entered in the Community Register of Medicinal Products and are to be given a number which must appear on the packaging. As pointed out by the Norwegian Government, that number is used for purposes of identification and supervision.
22 As the Commission correctly observed, every marketing authorisation issued in accordance with Regulation No 2309/93 relates to the specific presentation concerned, that is to say, to the size and form of the packaging prescribed for the medicinal product in the application for authorisation.
23 It should be recalled that Article 6(1) of Regulation No 2309/93 provides that an application for a marketing authorisation for a medicinal product must be accompanied by the particulars and documents listed in Articles 4 and 4a of Directive 65/65. Point 9 of the second paragraph of Article 4 of that directive states that the applicant must attach to his application `one or more specimens or mock-ups of the sales presentation of the medicinal product, together with a package leaflet where one is to be enclosed'.
24 Pursuant to Articles 9(3) and 10(1) and the second paragraph of Article 11 of Regulation No 2309/93, the authorisation issued by the Commission is to determine the dimensions, presentation and form of the packaging to be used for the medicinal product. Accordingly, the particulars and information to be printed on the product packaging are specific to that packaging, since they are based on the format and/or dimensions of that packaging, as specified in the application pursuant to Article 6(1) of that regulation.
25 In those circumstances, it must be concluded, as have the Norwegian Government and the Commission, that the detailed and specific requirements regarding the packaging of the medicinal products which are the subject of a central marketing authorisation, which are intended to prevent consumers from being misled and thereby to protect public health, preclude the bundling of the packages of those medicinal products.
26 In the light of that conclusion, it is for the national court, having regard to the case-law of the Court and, in particular, the judgment in Case C-443/99 Merck, Sharp & Dohme [2002] ECR I-0000, paragraph 25, to examine whether the circumstances prevailing at the time of marketing in the Member State of importation make the creation of new packaging objectively necessary in order that the imported product can gain effective access to the market of that State.
27 In the light of the foregoing, the answer to the first question must be that Regulation No 2309/93 precludes a medicinal product which is the subject of two separate central marketing authorisations, one for packs of five items and the other for packs of 10 items, from being marketed in a package consisting of two packs of five items which have been joined together and relabelled. The second question
28 In the light of the answer given to the first question, there is no need to examine the second question.