«(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

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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

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

(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 Lda, 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

1 This request for a preliminary ruling concerns the interpretation of Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ 2012 L 26, p. 1), as amended by Directive 2014/52/EU of the European Parliament and of the Council of 16 April 2014 (OJ 2014 L 124, p. 1) (‘Directive 2011/92’).

2 The request has been made in proceedings between, on the one hand, Waltham Abbey Residents Association and, on the other hand, An Bord Pleanála (Planning Board, Ireland; ‘the Board’), Ireland and the Attorney General (Ireland), concerning authorisation granted by the Board for a strategic residential housing development.

Legal context

European Union law

Directive 2011/92

3 Recitals 7 to 9 of Directive 2011/92 state:

‘(7) Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

(8) Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

ECLI:EU:C:2025:140

(9) Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

4 Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

…

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

Article 4 of Directive 2011/92 provides:

‘1. Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]

…

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

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.

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.

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.

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.

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.

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

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

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.

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).

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

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.

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).

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

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.

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.

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).

The Court of First Instance accordingly inferred that, leaving 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, since 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).

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, conversely, 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).

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).

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.

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).

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).

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.

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

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.