CELEX: 62003CJ0039
Language: en
Date: 2003-07-24 00:00:00
Title: Judgment of the Court (Full Court) of 24 July 2003. # Commission of the European Communities v Artegodan GmbH and Others. # Appeal - Directives 65/65/EEC and 75/319/EEC - Medicinal products for human use - Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine - Withdrawal of a marketing authorisation - Competence of the Commission - Conditions for withdrawal. # Case C-39/03 P.

Case C-39/03 P Commission of the European CommunitiesvArtegodan GmbH and Others
            «(Appeal – Directives 65/65/EEC and 75/319/EEC – Medicinal products for human use – Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine – Withdrawal of a marketing authorisation – Competence of the Commission – Conditions for withdrawal)»
            
               
                  Judgment of the Court (Full Court), 24 July 2003  
                     
               I - 0000 
               
            
                   
               
               
            
            Summary of the Judgment
         
         
                  
                  Approximation of laws – Proprietary medicinal products – Marketing authorisation – Withdrawal of authorisation – Authorisations granted in accordance with the mutual recognition procedure, coupled with arbitration procedures – Competence of the Commission with regard to authorisation initially granted under national procedures – None   (Council Directive 75/319, Art. 15a)Article 15a of Directive 75/319 relating to proprietary medicinal products, as amended by Directive 93/39, applies to marketing
         authorisations which have been granted in accordance with the mutual recognition procedure, coupled with arbitration procedures,
         provided for in Chapter III of Directive 75/319. That provision cannot be used as a legal basis for Commission decisions ordering
         the Member States to withdraw marketing authorisations initially granted under purely national procedures.    see paras 45-46, 51
      

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            JUDGMENT OF THE COURT (Full Court)24 July 2003  (1)
         
         
            
         
               ((Appeal – Directives 65/65/EEC and 75/319/EEC – Medicinal products for human use – Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine – Withdrawal of a marketing authorisation – Competence of the Commission – Conditions for withdrawal))
               
            In Case C-39/03 P, 
            
            
             Commission of the European Communities,  represented by R.B. Wainwright and H. Støvlbæk, acting as Agents, and B. Wägenbaur, Rechtsanwalt, with an address for service
            in Luxembourg,
            
            
            appellant, 
            
            APPEAL against the judgment of the Court of First Instance of the European Communities (Second Chamber, Extended Composition)
            of 26 November 2002 in Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00, T-137/00 and T-141/00  
             Artegodan and Others  v  
             Commission  [2002] ECR II-4945, seeking to have that judgment set aside,
            
            the other parties to the proceedings being: 
             Artegodan GmbH,   established in Lüchow (Germany), represented by U. Doepner, Rechtsanwalt, with an address for service in Luxembourg, Bruno Farmaceutici SpA , established in Rome (Italy), Essential Nutrition Ltd,  established in Brough (United Kingdom), Hoechst Marion Roussel Ltd,  established in Denham (United Kingdom), Hoechst Marion Roussel SA,  established in Brussels (Belgium), Marion Merrell SA,  established in Puteaux (France), Marion Merrell SA,  established in Barcelona (Spain), Sanova Pharma GmbH,  established in Vienna (Austria), Temmler Pharma GmbH & Co. KG,  established in Marburg (Germany), Schuck GmbH,  established in Schwaig (Germany), Laboratórios Roussel L
                da ,  established in Mem Martins (Portugal), Laboratoires Roussel Diamant SARL,  established in Puteaux, Roussel Iberica SA,  established in Barcelona,represented by B. Sträter and M. Ambrosius, Rechtsanwälte, with an address for service in Luxembourg, Gerot Pharmazeutika GmbH,  established in Vienna, represented by K. Grigkar, Rechtsanwalt, with an address for service in Luxembourg, Cambridge Healthcare Supplies Ltd,  established in Rackheath (United Kingdom), represented by D. Vaughan QC, K. Bacon, Barrister, and S. Davis, Solicitor, with
            an address for service in Luxembourg,and Laboratoires pharmaceutiques Trenker SA,  established in Brussels, represented by L. Defalque and X. Leurquin, avocats, with an address for service in Luxembourg,applicants at first instance,
            
            THE COURT (Full Court),,
            
            composed of: G.C. Rodríguez Iglesias, President, J.-P. Puissochet, M. Wathelet, R. Schintgen, C.W.A. Timmermans (Presidents of Chambers), C. Gulmann, D.A.O. Edward, A. La Pergola, P. Jann (Rapporteur), V. Skouris, F. Macken, N. Colneric, S. von Bahr, J.N. Cunha Rodrigues and A. Rosas, Judges, 
            
            Advocate General: S. Alber, Registrar: M. Múgica Arzamendi, Principal Administrator, 
            
            
            having regard to the decision of the President of the Court that the appeal was to be determined pursuant to an expedited
               procedure in accordance with Article 62a of the Rules of Procedure,
            after hearing oral argument from the parties at the hearing on 10 June 2003,
            
            after hearing the Advocate General,
         gives the following
         
         
         Judgment
         1
            
         By application lodged at the Court Registry on 3 February 2003, the Commission of the European Communities, in accordance
         with Article 225 EC and the first paragraph of Article 56 of the Statute of the Court of Justice, brought an appeal against
         the judgment of the Court of First Instance of 26 November 2002 in Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00,
         T-137/00 and T-141/00  
          Artegodan and Others  v  
          Commission  [2002] ECR II-4945 (
         the judgment under appeal), by which the Court of First Instance annulled, in so far as they related to the medicinal products marketed by the applicants
         at first instance, Commission Decisions C(2000) 452, C(2000) 453 and C(2000) 608 of 9 March 2000 concerning the withdrawal
         of marketing authorisations of medicinal products for human use containing phentermine (Decision C(2000) 452), amfepramone
         (Decision C(2000) 453) and other  
         amphetamine-like anorectic substances,  
          inter alia  norpseudoephedrine, clobenzorex and fenproporex (Decision C(2000) 608) (
         the decisions at issue). 
         
            
               Legal background
            Directive 65/65/EEC
         
         
         2
            
         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) (
         Directive 65/65), lays down the principle that no medicinal product may be placed on the market of a Member State unless an authorisation
         has been issued by the competent authority of that Member State in accordance with the 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). 
         
         
         3
            
         The first paragraph of Article 4 of Directive 65/65 provides that, in order to obtain an authorisation to place a medicinal
         product on the market as provided for in Article 3, the person responsible for placing that product on the market is to make
         application to the competent authority of the Member State concerned.  The third paragraph of Article 4 lists the particulars
         and documents which are to accompany the application.  These include, in point 9, a summary of the product characteristics.
         
         
         
         4
            
         Article 4a of Directive 65/65 provides: The summary of the product characteristics referred to in point 9 of the [third] paragraph of Article 4 shall contain the
         following information:1. Name of the [medicinal] product.2. Qualitative and quantitative composition in terms of the active ingredients and constituents of the excipient, knowledge
         of which is essential for proper administration of the medicinal product; ...3. Pharmaceutical form.4. Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars.5. Clinical particulars:5.1. therapeutic indications,5.2. contra-indications,5.3. undesirable effects (frequency and seriousness),5.4. special precautions for use,5.5. use during pregnancy and lactation,5.6. interaction with other medicaments and other forms of interaction,5.7. posology and method of administration for adults and, where necessary, for children,5.8. overdose (symptoms, emergency procedures, antidotes),5.9. special warnings,5.10. effects on ability to drive and to use machines.6. Pharmaceutical particulars:6.1. incompatibilities (major),6.2. shelf life, when necessary after reconstitution of the product or when the container is opened for the first time,6.3. special precautions for storage,6.4. nature and contents of container,6.5. name or style and permanent address or registered place of business of the holder of the marketing authorisation,6.6. special precautions for disposal of unused products or waste materials derived from such products, if appropriate.
         
         
         5
            
         As regards the grant of a marketing authorisation, the first paragraph of Article 5 of Directive 65/65 states: The authorisation provided for in Article 3 shall be refused if, after verification of the particulars and documents listed
         in Article 4, it proves that the medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy
         is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not
         as declared.
         
         
         6
            
         As regards the suspension or withdrawal of a marketing authorisation, the first paragraph of Article 11 of Directive 65/65
         provides: The competent authorities of the Member States shall suspend or revoke an authorisation to place a medicinal product on the
         market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking,
         or where its qualitative and quantitative composition is not as declared. ...
         Second Directive 75/319/EEC
         
         
         7
            
         Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative
         action relating to proprietary medicinal products (OJ 1975 L 147, p. 13), as amended by Directive 93/39, (
         Directive 75/319) contains a Chapter III entitled  
         Committee for Proprietary Medicinal Products (
         the CPMP) and consisting of Articles 8 to 15c, which has been completely rewritten by Directive 93/39. 
         
         
         8
            
         Article 9 of Directive 75/319 establishes a procedure for the mutual recognition of national marketing authorisations.  It
         states: 1. In order to obtain the recognition according to the procedures laid down in this chapter in one or more of the Member States
         of an authorisation issued by a Member State in accordance with Article 3 of Directive 65/65/EEC, the holder of the authorisation
         shall submit an application to the competent authorities of the Member State or Member States concerned, together with the
         information and particulars referred to in Articles 4, 4a and 4b of Directive 65/65/EEC. ......4. Save in the exceptional case provided for in Article 10(1), each Member State shall recognise the marketing authorisation
         granted by the first Member State within 90 days ....
         
         
         9
            
         Article 10(1) and (2) of Directive 75/319 provides: 1. Notwithstanding Article 9(4), where a Member State considers that there are grounds for supposing that the authorisation
         of the medicinal product concerned may present a risk to public health ... , it shall forthwith inform the applicant, the
         Member State which granted the initial authorisation, any other Member States concerned by the application and the [CPMP].
         ...2. All the Member States concerned shall use their best endeavours to reach agreement on the action to be taken in respect
         of the application. ... However, if the Member States have not reached agreement within the time-limit referred to in Article
         9(4) they shall forthwith refer the matter to the [CPMP] for the application of the procedure laid down in Article 13.
         
         
         10
            
         Article 11 of Directive 75/319 states that if several applications have been made for national marketing authorisations for
         a particular medicinal product, and Member States have adopted divergent decisions, a Member State, the Commission or the
         person responsible for placing the medicinal product on the market may refer the matter to the CPMP for application of the
         procedure laid down in Article 13 of that directive. 
         
         
         11
            
         The first paragraph of Article 12 of Directive 73/319 provides: The Member States or the Commission or the applicant or holder of the marketing authorisation may, in specific cases where
         the interests of the Community are involved, refer the matter to the [CPMP] for the application of the procedure laid down
         in Article 13 before reaching a decision on a request for a marketing authorisation or on the suspension or withdrawal of
         an authorisation, or on any other variation to the terms of a marketing authorisation which appears necessary, in particular
         to take account of the information collected [under the pharmacovigilance system provided for in] Chapter Va.
         
         
         12
            
         Article 15a of Directive 75/319 states: 1. Where a Member State considers that the variation of the terms of a marketing authorisation which has been granted in accordance
         with the provisions of this chapter or its suspension or withdrawal is necessary for the protection of public health, the
         Member State concerned shall forthwith refer the matter to the [CPMP] for the application of the [procedures] laid down in
         Articles 13 and 14.2. Without prejudice to the provisions of Article 12, in exceptional cases, where urgent action is essential to protect public
         health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the medicinal product
         concerned on its territory.  It shall inform the Commission and the other Member States no later than the following working
         day of the reasons for its action.
         
         
         13
            
         As regards procedural issues, Article 13 of Directive 75/319, which governs the procedure before the CPMP, provides that at
         the end of that procedure the CPMP is to issue a reasoned opinion.  Article 13(5) states that the European Agency for the
         Evaluation of Medicinal Products (
         the Agency) is to forward the final opinion of the CPMP to the Member States, the Commission and the person responsible for placing
         the medicinal product on the market, together with a report describing the assessment of the medicinal product and stating
         the reasons for its conclusions. 
         
         
         14
            
         Article 14 of Directive 75/319 lays down the procedure to be followed after the Commission receives the opinion of the CPMP.
          Pursuant to the first subparagraph of Article 14(1), within 30 days of the receipt of that opinion the Commission is to prepare
         a draft of the decision to be taken in respect of the application.  The third subparagraph of Article 14(1) states that  
         [w]here, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also
         annex a detailed explanation of the reasons for the differences. 
         Background to the dispute
         
         15
            
         Artegodan GmbH, Bruno Farmaceutici SpA, Essential Nutrition Ltd, Hoechst Marion Roussel Ltd, Hoechst Marion Roussel SA, Marion
         Merrell SA (France), Marion Merrell SA (Spain), Sanova Pharma GmbH, Temmler Pharma GmbH & Co. KG, Schuck GmbH, Laboratórios
         Roussel L
          da , Laboratoires Roussel Diamant SARL, Roussel Iberica SA, Gerot Pharmazeutika GmbH, Cambridge Healthcare Supplies Ltd and Laboratoires
         pharmaceutiques Trenker SA are holders of marketing authorisations, initially issued by the competent national authorities,
         for medicinal products containing  
         amphetamine-like anorectic agents, namely, as the case may be, phentermine, amfepramone, clobenzorex, fenproporex or norpseudoephedrine. 
         Commission Decision C(96) 3608 final/1
         
         
         16
            
         After a referral had been made to it by the Federal Republic of Germany under Article 12 of Directive 75/319, the CPMP initiated
         the procedure provided for in Article 13 of that directive, in accordance with which, on 17 July 1996, it issued three final
         opinions on various  
         amphetamine-like anorectics. 
         
         
         17
            
         That procedure led to the adoption of Commission Decision C(96) 3608 final/1 of 9 December 1996 concerning the placing on
         the market of the medicinal products for human use which contain the following substances: clobenzorex, norpseudoephedrine,
         phentermine, fenproporex, mazindol, amfepramone, phendimetrazine, phenmetrazine, mefenorex (
         the 1996 decision). 
         
         
         18
            
         By that decision, which was expressly based on Article 14 of Directive 75/319, the Commission, in accordance with the CPMP
         opinions of 17 July 1996, instructed the Member States concerned to amend certain clinical particulars in the summaries of
         product characteristics approved when the marketing authorisations of the medicinal products in question were granted.  It
         stipulated that a series of clinical particulars be included, relating to the therapeutic indications, posology, method of
         administration, contraindications, special warnings and precautions for use, and undesirable effects of those medicinal products.
         
         The decisions at issue
         
         
         19
            
         In response to information submitted by the Belgian and Austrian Governments, the CPMP initiated the procedure provided for
         in Article 13 of Directive 75/319 in respect of phentermine, amfepramone and other  
         amphetamine-like anorectics,  
          inter alia  clobenzorex, fenproporex and norpseudoephedrine.  On 31 August 1999 it issued three final opinions. 
         
         
         20
            
         On 9 March 2000, on the basis of Article 15a of Directive 75/319, the Commission adopted the decisions at issue concerning
         the withdrawal of marketing authorisations of medicinal products for human use which contain phentermine (Decision C(2000)
         452), amfepramone (Decision C(2000) 453) and the following substances: clobenzorex, fenbutrazate, fenproporex, mazindol, mefenorex,
         norpseudoephedrine, phenmetrazine, phendimetrazine or propylhexedrine (Decision C(2000) 608). 
         
         
         21
            
         In Article 1 of the operative part of each of the decisions at issue, the Commission ordered the Member States to  
         withdraw the national marketing authorisations provided for in the first paragraph of Article 3 of Directive 65/65 ... concerning
         the medicinal products listed in Annex I [to the decision] which contain the [substance or substances assessed].  Article 2 of each of the decisions at issue justified that withdrawal by referring to the Agency's scientific conclusions
         on the substance or substances concerned, included as Annex II to the respective decision.  Article 3 of each of the decisions
         at issue required the Member States concerned to comply with the decision within 30 days of its notification. 
         The judgment under appeal
         
         22
            
         By the judgment under appeal, the Court of First Instance annulled the three decisions at issue in so far as they relate to
         the medicinal products marketed by the applicants at first instance. 
         
         
         23
            
         In the first place, the Court of First Instance upheld the plea put forward by the applicants at first instance alleging the
         Commission's lack of competence to take the decisions at issue. 
         
         
         24
            
         The Court of First Instance first of all found that it was common ground between the parties that the marketing authorisations
         of the medicinal products referred to by the decisions at issue had been granted, and in some cases renewed, in accordance
         with the national procedures applicable in the various Member States concerned, and not in accordance with the mutual recognition
         procedure, coupled with arbitration procedures, provided for in Chapter III of Directive 75/319 (paragraph 113 of the judgment
         under appeal). 
         
         
         25
            
         The Court of First Instance accordingly inferred that,  
         [l]eaving aside the [1996] decision ..., those authorisations were thus purely national and that  
         the suspension, variation or withdrawal of those authorisations therefore came, at the time when the [decisions at issue]
         were adopted, within the exclusive competence of the Member States concerned, a competence which, following the introduction
         of the mutual recognition procedure by Directive 93/39, is essentially residual (paragraph 114 of the judgment under appeal).  According to the Court of First Instance's interpretation of the Community
         legislation,  
         [s]ince 1 January 1995 that exclusive competence [of the Member States] has been restricted to, first, the grant and management
         of marketing authorisations for medicinal products marketed solely in a single Member State and, second, the management of
         purely national marketing authorisations granted before that date or during the transitional period from 1 January 1995 to
         31 December 1997 (paragraph 116 of the judgment under appeal). 
         
         
         26
            
         The Court of First Instance then examined whether, following their amendment pursuant to the 1996 decision, the marketing
         authorisations of the medicinal products in question fell within the scope of Article 15a(1) of Directive 75/319, which is
         the legal basis on which the Commission adopted the decisions at issue. Finding that that provision refers to marketing authorisations
         granted in accordance with the provisions of Chapter III of that directive, the Court of First Instance interpreted it to
         mean that  
         the variation, suspension or withdrawal of such authorisations, on the initiative of a Member State with a view to the protection
         of public health, fall within the exclusive competence of the Commission, when adopting a decision following a CPMP opinion
         in accordance with the procedures laid down in Articles 13 and 14 of Directive 75/319 while,  
         [c]onversely, the variation, suspension and withdrawal of marketing authorisations which do not fall within the ambit of Article
         15a remain, in principle, subject to the exclusive competence of the Member States (paragraph 121 of the judgment under appeal). 
         
         
         27
            
         The Court of First Instance held that since the wording of Articles 12 and 15a of Directive 75/319 provided no clear guidance
         it was necessary to consider whether, in the scheme of Chapter III of that directive, and in the light of the directive's
         aims, Article 15a(1), in conjunction with Article 12, could be construed as also applying to national marketing authorisations
         which have been harmonised under Article 12 (paragraph 125 of the judgment under appeal). 
         
         
         28
            
         To that end, the Court of First Instance considered the question of which authority is competent to adopt a decision following
         a CPMP opinion under Article 12 of Directive 75/319, an article which does no more than expressly provide for the application
         of the consultative procedure set out in Article 13 of that directive.  It held in that respect that Article 12 of Directive
         75/319  
         is intended to apply in the residual field of exclusive competence of the Member States, or when the initial marketing authorisation
         of a medicinal product is granted by the reference Member State (paragraph 142 of the judgment under appeal) and that it  
         cannot be interpreted as implicitly empowering the Commission to adopt a binding decision under the procedure set out in Article
         14 of that directive (paragraph 147 of the judgment under appeal), unlike Article 10(2) which, although it also refers to the
         consultative procedure set out in Article 13, is none the less part of a different framework, that of the mutual recognition
         procedure (paragraphs 130 to 133 of the judgment under appeal).  The Court of First Instance reached these conclusions by
         means of an interpretative approach based in particular on the scheme of Chapter III of Directive 75/319 and its objectives.
         
         
         
         29
            
         The Court of First Instance noted that the 1996 decision had been complied with by the Member States and found, finally, that
         it was none the less necessary to consider whether, in the scheme of Chapter III of Directive 75/319, marketing authorisations
         harmonised by the Member States following consultation of the CPMP under Article 12 of that directive could nevertheless be
         placed on the same footing as marketing authorisations granted in accordance with the provisions of Chapter III (paragraph
         148 of the judgment under appeal). 
         
         
         30
            
         In that connection, the Court of First Instance found that  
         in the absence of an express provision, the principle, set out in the first paragraph of Article 5 EC, that the Community
         is to act within the limits of the powers conferred upon it, precludes an interpretation of Article 15a(1) of Directive 75/319
         to the effect that the harmonisation of certain marketing authorisations, in accordance with a non-binding opinion of the
         CPMP under Article 12 of that directive, can have the effect of depriving the Member States concerned of their powers, by
         triggering the application of the arbitration procedure provided for in Article 15a in respect of the adoption of any subsequent
         decision regarding the suspension or withdrawal of such authorisations (paragraph 150 of the judgment under appeal).  It thus held that,  
         in the scheme of Directive 75/319, the concept of a marketing authorisation granted in accordance with the provisions of Chapter
         III of that directive, referred to in Article 15a(1), cannot be interpreted as also including authorisations harmonised following
         consultation of the CPMP under Article 12 (paragraph 155 of the judgment under appeal). 
         
         
         31
            
         The Court of First Instance accordingly concluded that the decisions at issue had no legal basis and that the plea in law
         alleging the Commission's lack of competence was well founded. 
         
         
         32
            
         In the second place, the Court of First Instance held that, even assuming that the Commission had been competent to adopt
         the decisions at issue, they would nevertheless be flawed on the ground of infringement of Article 11 of Directive 65/65 (paragraphs
         156 and 170 to 221 of the judgment under appeal). 
         Procedure before the Court and the forms of order sought
         
         33
            
         By separate document lodged at the Court Registry on 3 February 2003, the Commission requested the Court to order that the
         case be determined pursuant to an expedited procedure, in accordance with Article 62a of the Rules of Procedure. 
         
         
         34
            
         By separate document lodged at the Court Registry on the same day, the Commission applied to the Court under Article 242 EC
         for suspension of operation of the judgment under appeal. 
         
         
         35
            
         On the basis of a recommendation by the Judge-Rapporteur and after hearing the respondents and the Advocate General, the President
         of the Court decided, on 26 February 2003, that the case should be determined pursuant to an expedited procedure. 
         
         
         36
            
         By order of 8 May 2003 in Case C-39/03 P-R  
          Commission   v  
          Artegodan and Others  [2003] ECR I-4485 the President of the Court dismissed the application for suspension of operation of the judgment under
         appeal. 
         
         
         37
            
         The Commission claims that the Court should set aside the judgment under appeal and order the respondents to pay the costs.
         
         
         
         38
            
         The respondents contend that the Court should dismiss the appeal and order the Commission to pay the costs. 
         The appeal
         
         39
            
         In support of its appeal, the Commission raises pleas in law relating, first, to the reasoning of the Court of First Instance
         on the Commission's lack of competence to adopt the decisions at issue and, second, to the interpretation adopted by the Court
         of First Instance of the conditions for withdrawal of the marketing authorisations, such as those conditions are defined by
         the first paragraph of Article 11 of Directive 65/65. 
         
         
         40
            
         As to its competence to adopt the decisions at issue, the Commission principally claims that the Court of First Instance misinterpreted
         Articles 15a and 12 of Directive 75/319 in holding that those articles did not confer on the Commission the competence to
         adopt the decisions at issue.  In the alternative, it claims that the Court of First Instance misinterpreted those articles
         by failing to take into consideration the effects of the harmonisation of the marketing authorisations of the medicinal products
         in question, which had been effected by the 1996 decision. 
         
         
         41
            
         By the first part of its principal plea in law, the Commission submits that the Court of First Instance misinterpreted both
         the wording and the purpose of Article 15a of Directive 75/319.  In its reference to a marketing authorisation  
         which has been granted in accordance with the provisions of [Chapter III of Directive 75/319], that provision refers to the whole of that chapter, and in particular to Articles 10, 11 and 12 thereof.  Like those three
         articles, Article 15a of Directive 75/319 is intended to prevent Member States from taking divergent unilateral measures with
         respect to the marketing authorisation for a given medicinal product, in order to ensure a high degree of protection of public
         health in all Member States.  On the basis of an historical approach to the interpretation of Chapter III of Directive 75/319,
         the Commission asserts that Article 15a must be regarded as a  
         follow-up procedure and must apply to all the procedures set out in Chapter III.
         
         
         42
            
         According to the Commission, the Court of First Instance also misinterpreted the division of powers between the Community
         and the Member States, laid down in Directive 75/319.  In contrast to what the Court of First Instance held, in particular
         in paragraphs 116 and 121 of the judgment under appeal, that directive does not delimit the respective  
         exclusive competences of the Member States and the Commission.  In actual fact, the provisions of Chapter III of Directive 75/319 form
         part of an approach based on shared and complementary powers, whereby the Member States are responsible for national marketing
         authorisations for medicinal products for human use and the Community is responsible for protecting public health and the
         single market for medicinal products whenever this is required in the various situations referred to in Articles 10, 11, 12
         and 15a of that directive.  In those situations, the Member States are responsible for launching an arbitration procedure
         by referring the matter to the CPMP for the application of the procedures laid down in Articles 13 and 14 of the directive.
          The Commission is then empowered to adopt a decision, the implementation of which is incumbent on the Member States. 
         
         
         43
            
         The respondents dispute the Commission's analysis.  They essentially submit that the clear wording of Article 15a(1) of Directive
         75/319 makes a detailed examination of that provision redundant.  Its sole purpose is to ensure that marketing authorisations
         are not treated differently in different Member States once they have been issued under the mutual recognition procedure.
          The 1996 decision did not result in harmonisation for the simple reason that that decision related only to the summaries
         of product characteristics of the medicinal products in question.  It was a question of supplementing the national marketing
         authorisations in respect of the active substances of those medicinal products.  An amendment of that kind cannot be placed
         on the same footing as a decision under a mutual recognition procedure and consequently the competence to amend, suspend or
         withdraw the marketing authorisations of the medicinal products in question remains with the Member States.  No other construction
         of Article 15a of Directive 75/319 can be based on an historical interpretation of Chapter III of that directive or, moreover,
         reconciled with the subsidiarity principle enshrined in Article 5 EC. 
         
         
         44
            
         In that regard, it should be noted that the decisions at issue were adopted solely on the basis of Article 15a of Directive
         75/319. 
         
         
         45
            
         According to its wording, Article 15a of Directive 75/319 applies to marketing authorisations which have been granted in accordance
         with the provisions of Chapter III of that directive. 
         
         
         46
            
         The Court of First Instance found, and this was not contested by the Commission, that the marketing authorisations whose withdrawal
         was ordered by the decisions at issue were initially granted under purely national procedures. 
         
         
         47
            
         Assuming that the purpose of Article 15a of Directive 75/319 is to be interpreted broadly and the provision can thus be held
         to apply to marketing authorisations which have not been granted under Chapter III but which have been the subject of another
         harmonisation procedure, it becomes necessary in the present case to determine whether the 1996 decision can be regarded as
         having brought about such harmonisation. 
         
         
         48
            
         It is common ground that the 1996 decision merely ordered the amendment of certain terms of the initial marketing authorisations,
         namely the clinical particulars which, along with other data, must be included in the summary of product characteristics in
         accordance with point 5 of Article 4a of Directive 65/65. 
         
         
         49
            
         A partial amendment of that kind cannot amount to an authorisation granted in accordance with the provisions of Chapter III
         of Directive 75/319. 
         
         
         50
            
         It is therefore of no importance whether that partial amendment of the marketing authorisations of the medicinal products
         in question was the result of compliance with a binding decision or of voluntary harmonisation by the Member States. 
         
         
         51
            
         It follows that Article 15a of Directive 75/319 could not be used as a legal basis for the decisions at issue. 
         
         
         52
            
         In those circumstances, and without it being necessary to rule on the other pleas and arguments put forward by the Commission,
         the Court finds that the Court of First Instance was right to hold that the Commission lacked the competence to adopt the
         decisions at issue and that, accordingly, those decisions had to be annulled. 
         
         
         53
            
         It follows from all the foregoing considerations that the appeal must be dismissed. 
         
         Costs
         54
            
         Under Article 69(2) of the Rules of Procedure, applicable to the procedure on appeal by virtue of Article 118 of the Rules,
         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 respondents have applied for costs and the Commission has been unsuccessful, the latter must be ordered to pay the
         costs of these proceedings and of those relating to the application for interim relief. 
         
         On those grounds, 
         
         
         
            
            THE COURT (Full Court),
         
         
         hereby: 
         
            
            1.
              Dismisses the appeal;  
            
            
            2.
              Orders the Commission of the European Communities to pay the costs of these proceedings and those relating to the application
               for interim relief.  
            
            
                  Rodríguez Iglesias
               
               
                  Puissochet 
               
               
                  Wathelet 
               
            
                  Schintgen
               
               
                  Timmermans 
               
               
                  Gulman 
               
            
                  Edward
               
               
                  La Pergola 
               
               
                  Jann 
               
            
                  Skouris
               
               
                  Macken 
               
               
                  Colneric 
               
            
                  von Bahr
               
               
                  Cunha Rodrigues 
               
               
                  Rosas 
               
            
            
            
            
            
            
            
            
         
         
         Delivered in open court in Luxembourg on 24 July 2003. 
         
         
         
         
                  R. Grass 
               
               
                  G.C. Rodríguez Iglesias  
               
            
         
         
         
                  Registrar
               
               
                  President
               
            
      
      
          1 –
            
             Languages of the case: German,Englishand French.