CELEX: 62003CJ0122
Language: en
Date: 2003-12-11 00:00:00
Title: Judgment of the Court (Third Chamber) of 11 December 2003. # Commission of the European Communities v French Republic. # Failure of a Member State to fulfil its obligations - Measures having equivalent effect - Importers and distributors of medicinal products - Submission of a certified copy or a document attesting to the holding of a marketing authorisation. # Case C-122/03.

Case C-122/03 Commission of the European CommunitiesvFrench Republic
            «(Failure of a Member State to fulfil obligations – Measures having equivalent effect – Importers and distributors of medicinal products – Submission of a certified copy or a document attesting to the holding of a marketing authorisation)»
            
               
                  Judgment of the Court (Third Chamber), 11 December 2003  
                     
               I - 0000 
               
            
                   
               
               
            
            Summary of the Judgment
         
         
                  
                  Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Medicinal products covered by a marketing authorisation – Obligation to submit a certified copy or a certificate of attestation of that authorisation – Not permissibleThe imposition on traders importing or distributing in France medicinal products which are already covered by a marketing
         authorisation for the French or Community market a requirement that they submit, when first so requested by the monitoring
         authorities, either a certified copy issued by the national health safety agency of the national marketing authorisation or
         of the registration of the medicinal product, or a document issued by that Agency certifying that the imported medicinal product
         has obtained a marketing authorisation issued by the European Community, constitutes a failure by a Member Stare to fulfil
         its obligations under Article 28 EC.see operative part
      

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            JUDGMENT OF THE COURT (Third Chamber)11 December 2003 (1)
         
         
            
         
               ((Failure of a Member State to fulfil its obligations – Measures having equivalent effect – Importers and distributors of medicinal products – Submission of a certified copy or a document attesting to the holding of a marketing authorisation))
               
            In Case C-122/03, 
            
            
             Commission of the European Communities,  represented by H. Støvlbæk and B. Stromsky, acting as Agents, with an address for service in Luxembourg,
            
            
            applicant, 
            
            v
             French Republic,  represented by G. de Bergues and C. Bergeot-Nunes, acting as Agents,
            
            defendant, 
            
            APPLICATION for a declaration that, by imposing, pursuant to Article R. 5142-15 of the Code de la santé publique, on traders
            importing or distributing in France medicinal products which are already covered by a marketing authorisation for the French
            or Community market a requirement that they submit, when first so requested by the monitoring authorities, either a certified
            copy issued by the Agence française de securité sanitaire des produits de santé of the French marketing authorisation or of
            the registration of the medicinal product, or a document issued by that Agency attesting that the imported medicinal product
            has obtained a marketing authorisation issued by the European Community, the French Republic has failed to fulfil its obligations
            under Article 28 EC,
            
            
            THE COURT (Third Chamber),,
            
            composed of: C. Gulmann (Rapporteur), acting for the President of the Third Chamber, J.-P. Puissochet and F. Macken, Judges, 
            
            Advocate General: L.A. Geelhoed, Registrar: R. Grass, 
            
            
            having regard to the report of the Judge-Rapporteur,
            
                  having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,
         gives the following
         
         
         Judgment
         1
            
         By application lodged at the Court Registry on 19 March 2003, the Commission of the European Communities brought an action
         under Article 226 EC for a declaration that, by imposing, pursuant to Article R. 5142-15 of the Code de la santé publique
         (French Public Health Code), on traders importing or distributing in France medicinal products which are already covered by
         a marketing authorisation for the French or Community market a requirement that they submit, when first so requested by the
         monitoring authorities, either a certified copy issued by the Agence française de securité sanitaire des produits de santé
         (French Agency for Health Product Safety) of the French marketing authorisation or of the registration of the medicinal product,
         or a document issued by that Agency attesting that the imported medicinal product has obtained a marketing authorisation issued
         by the European Community, the French Republic has failed to fulfil its obligations under Article 28 EC. 
         
            
               Legal background
            Community legislation
          
         
         2
            
          Article 28 EC provides that quantitative restrictions on imports and all measures having equivalent effect are to be prohibited
         between Member States. 
         
         
         3
            
         Article 30 EC states that the provisions of Article 28 EC are not to preclude prohibitions or restrictions on imports justified
          
          inter alia   on grounds of the protection of health and life of humans. Such prohibitions or restrictions are not, however, to constitute
         a means of arbitrary discrimination or a disguised restriction on trade between Member States. 
         
         
         4
            
         According to Article 3 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 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22), no medicinal product may be placed on the market in
         a Member State unless a marketing authorisation (hereinafter  
         MA) 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 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). 
         
         
         5
            
         Article 2(1) of 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) requires that particulars of  
          inter alia   the MA number appear on the outer packaging of medicinal products or, where there is no exterior packaging, on the immediate
         packaging. 
         National legislation
         
         
         6
            
         Article R. 5142-15 of the Code de la santé publique, as amended by Decree No 99-144 of 4 March 1999 (JORF of 5 March 1999,
         p. 3294, hereinafter  
         the contested provision) is worded as follows: On request by customs officers, where a medicinal product has a Community status within the meaning of Article 4 of Council
         Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code, and in other cases in support of the
         customs declaration, there shall be submitted:
         
         1.
          ... 
         
         
         2.
          either a certified copy issued by the Agence française de sécurité sanitaire des produits de santé of the [MA] or of the registration
         of the medicinal product, 
         
         
         3.
          or a document issued by the Agence française de securité sanitaire des produits de santé attesting that the imported medicinal
         product has obtained an [MA] issued by the European Community.
         
         Pre-litigation procedure
         
         7
            
         As it considered that the contested provision and its implementation by the French authorities were likely to constitute a
         measure having an effect equivalent to a quantitative restriction, prohibited by Article 28 EC, the Commission sent to the
         French Republic on 3 June 1999 a letter of formal notice in accordance with Article 226 EC. 
         
         
         8
            
         By letter of 13 September 1999 the French authorities replied to that letter of formal notice, announcing  
          inter alia  their intention to adopt a new decree repealing the contested provision and to replace it with a system for monitoring the
         MA number appearing on the packaging of medicinal products. 
         
         
         9
            
         On 31 March 2000, the French authorities notified the Commission of a draft decree amending  
          inter alia  the contested provision and stating that  
         for medicinal products bearing the [MA] referred to in Article L. 601, or the registration referred to in Article L. 603,
         customs officers shall check the [MA] number or the corresponding registration number which appears on the packaging. This
         will be done either in the course of random checks, where the medicinal product has a Community status, or when the customs
         declaration is lodged in other cases. 
         
         
         10
            
         In a letter of 10 July 2000 addressed to the French authorities, the Commission intimated that it considered that the contested
         provision as amended by the draft decree represented a satisfactory response to the objections raised in the letter of formal
         notice, and requested the French authorities to adopt the amended version as soon as possible. 
         
         
         11
            
         In a letter of 4 December 2000, the French authorities stated that they did not consider it necessary to adopt the new Article
         R. 5142-15 of the Code de la santé publique separately from other provisions that were under preparation relating to parallel
         importing of medicinal products. 
         
         
         12
            
         As it considered that the breach of Community law remained unremedied the Commission sent a reasoned opinion to the French
         Republic on 29 December 2000 requesting it to adopt the measures necessary to comply with the opinion within two months of
         its notification. 
         
         
         13
            
         By letter of 18 March 2001, the French authorities replied that the draft decree relating to imports of medicinal products
         for human use was practically finalised and would be considered by the French Conseil d'État as soon as the Conseil de la
         concurrence (Competition Council) had given its opinion. They stated again that they considered it pointless and technically
         problematic to adopt the new version of the contested provision separately from other provisions relating to parallel importing
         of medicinal products. 
         
         
         14
            
         At a meeting held on 23 January 2002, the French authorities informed the Commission that the draft decree relating to imports
         of medicinal products for human use had been sent to the relevant ministers for signature on 10 August 2001, but that it had
         still not been signed. 
         
         
         15
            
         In those circumstances, the Commission decided to bring the present action. 
         Substance
         
         16
            
         The Commission claims that the contested provision is capable of hindering, directly or indirectly, actually or potentially,
         intra-Community trade and that it therefore constitutes a measure having an effect equivalent to a quantitative restriction,
         prohibited by Article 28 EC. 
         
         
         17
            
         The Commmission observes first of all that, as regards the period before the products are imported, the requirement under
         the contested provision to submit documents necessitates an administrative involvement with the French authorities, thereby
         hindering the import of medicinal products in France. 
         
         
         18
            
         In relation, next, to the actual importation of the products, the Commission claims, first, that the requirement to submit
          
         on request by customs officers either a certified copy of the MA or of the registration of the medicinal product, or a document attesting that the imported
         medicinal product has obtained an MA issued by the European Community, imposes an obligation on importers and distributors
         permanently to retain the necessary documents. Secondly, the number and volume of the necessary documents could give rise
         to transport difficulties at all statges of import and distribution. 
         
         
         19
            
         The Commission argues lastly that the French authorities have put forward no justification in support of the contested provision.
         Even supposing that the contested provision could have been prompted by the objective of protecting health and life of humans,
         it would not comply with the requirements of Article 30 EC. If the objective of the contested provision were to enable the
         competent authorities to verify that a French or Community MA has been obtained, it could be attained as effectively by a
         system which is less of an obstacle to intra-Community trade, for example by checking the number on the external packaging
         of the medicinal product, as the draft decree amending the provision in issue stipulated. 
         
         
         20
            
         The French Government states in response that the draft decree amending the provision in issue was ultimately not adopted.
         It explains that on the change in government, the draft was the subject of new discussions with the trade. Following those
         discussions, a fresh draft decree was prepared. While it differs in some ways from the previous draft, the substance of the
         provision amending the provision in issue nevertheless remains unchanged.  
         
         
         21
            
         Before being signed and publicised, the new draft decree will require to be considered again by the Conseil d'État, and the
         matter will be brought before it in June 2003. The French Government has given assurances that it will strive to ensure that
         this decree is adopted as swiftly as possible. 
         
         
         22
            
         The French Government does not dispute the failure to fulfil its obligations and the Commission's action must therefore be
         held to be well founded. 
         
         Costs
         23
            
         Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been
         applied for in the successful party's pleadings. Since the Commission has applied for costs and the French Republic has been
         unsuccessful, the latter must be ordered to pay the costs. 
         
         On those grounds, 
         
         
         
            
            THE COURT (Third Chamber),
         
         
         hereby: 
         
            
            1.
             Declares that by imposing, pursuant to Article R. 5142-15 of the Code de la santé publique, on traders importing or distributing
            in France medicinal products which are already covered by a marketing authorisation for the French or Community market a requirement
            that they submit, when first so requested by the monitoring authorities, either a certified copy issued by the Agence française
            de securité sanitaire des produits de santé of the French marketing authorisation or of the registration of the medicinal
            product, or a document issued by that Agency certifying that the imported medicinal product has obtained a marketing authorisation
            issued by the European Community, the French Republic has failed to fulfil its obligations under Article 28 EC; 
            
            
            2.
              Orders the French Republic to pay the costs. 
            
            
                  Gulmann
               
               
                  Puissochet 
               
               
                  Macken 
               
            
                  
               
               
                  
               
               
                  
               
            
                  
               
               
                  
               
               
                  
               
            
                  
               
               
                  
               
               
                  
               
            
                  
               
               
                  
               
               
                  
               
            
            
            
            
            
            
            
            
         
         
         Delivered in open court in Luxembourg on 11 December 2003. 
         
         
         
         
                  R. Grass 
               
               
                  V. Skouris  
               
            
         
         
         
                  Registrar
               
               
                   President
               
            
      
      
          1 –
            
             Language of the case: French.