(Reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen)

(Free movement of goods – Medicinal products – Importation – Application for marketing authorisation under a simplified procedure – Common origin)

Summary of the Judgment

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Medicinal products – Application for a marketing authorisation with reference to a medicinal product that has already been authorised – Possibility of transposing the safety and efficacy assessment carried out for that medicinal product without any risk to public health – Rejection of the application because the medicinal products do not have a common origin – Not permissible – Justification – None

(Arts 28 EC and 30 EC)

In the case where

– an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised,

– the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation,

– the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health,

Articles 28 EC and 30 EC preclude the application being rejected solely on the ground that the two medicinal products do not have a common origin, that is, that their manufacturers are not part of the same group of undertakings and they do not produce those medicinal products under agreement with the same licensor.

In such circumstances, the restriction on the free movement of goods between Member States which results from the refusal to issue a marketing authorisation to the second medicinal product cannot be justified on grounds of protecting public health if that refusal is based solely on the fact that the two medicinal products do not have the same origin. A common origin may indeed constitute an important element in establishing that the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health. The absence of a common origin for the two medicinal products does not, however, in itself constitute a ground for refusing a marketing authorisation to the second medicinal product.

(see paras 15-18, 21, operative part)

1 April 2004*

(Free movement of goods – Medicinal products – Importation – Application for marketing authorisation under a simplified procedure – Common origin)

In Case C-112/02,

REFERENCE to the Court under Article 234 EC by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (Germany) for a preliminary ruling in the proceedings pending before that court between

Bundesrepublik Deutschland,

on the interpretation of Community law, in particular Articles 28 EC and 30 EC,

THE COURT (Sixth Chamber),

composed of: C. Gulmann (Rapporteur), acting for the President of the Sixth Chamber, J.N. Cunha Rodrigues, J.-P. Puissochet, R. Schintgen and F. Macken, Judges,

Advocate General: A. Tizzano, Registrar: H.A. Rühl, Principal Administrator,

after considering the written observations submitted on behalf of:

– Kohlpharma GmbH, by W.A. Rehmann, Rechtsanwalt,

– the Commission of the European Communities, by H. Støvlbæk and S. Fries, acting as Agents,

after hearing the oral observations of Kohlpharma GmbH, represented by W.A. Rehmann; of the Bundesinstitut für Arzneimittel und Medizinprodukte, represented by M. Wagner and A. von Hagen, acting as Agents; and of the Commission, represented by H. Støvlbæk and S. Fries, at the hearing on 13 March 2003,

after hearing the Opinion of the Advocate General at the sitting on 11 September 2003,

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

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.

(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.’

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.

3. A description of any likely significant effects, to the extent of the information available on such effects, of the project on the environment resulting from:

(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

The refusal to issue a marketing authorisation for a medicinal product imported from another Member State, in which that product was issued a marketing authorisation, constitutes a restriction on the free movement of goods between Member States. Such a restriction is contrary to Article 28 EC unless it is warranted by imperative needs, in particular the protection of public health.

14It is for the competent national authorities, before they issue a marketing authorisation, to ensure that the primary objective of the Community legislation, namely the safeguarding of public health, is fully complied with. Nevertheless, the principle of proportionality requires that, in order to protect the free movement of goods, the legislation in question be applied within the limit of what is necessary in order to achieve the aim of protecting health that is legitimately being pursued (see, to that effect, Case C-172/00 Ferring [2002] ECR I-6891, paragraph 34).

15Once it has been established that the safety and efficacy assessment carried out for the medicinal product which is already authorised can, without any risk to the protection of public health, be used in respect of the medicinal product for which marketing authorisation is sought, the restriction on the free movement of goods between Member States which results from the refusal to issue a marketing authorisation to the second medicinal product cannot be justified on grounds of protecting public health if that refusal is based solely on the fact that the two medicinal products do not have the same origin.

16In a situation such as that in the main proceedings, the problem confronting the competent authorities as regards marketing authorisations for medicinal products is whether, as is claimed by the applicant for a marketing authorisation, the safety and efficacy assessment carried out for the medicinal product which has already been authorised can indeed be applied to the application for a marketing authorisation for the second medicinal product without any risk to the protection of public health.

17In that regard, a common origin of the two medicinal products may constitute an important element in establishing that such is the case.

18Nevertheless, the absence of a common origin for the two medicinal products does not in itself constitute a ground for refusing a marketing authorisation to the second medicinal product.

19In circumstances such as those in the main proceedings, which are characterised by the fact that an active ingredient is sold to two different manufacturers established in two Member States, the applicant for marketing authorisation for the second medicinal product may, for the purpose of assessing its safety and efficacy, demonstrate by means of available or accessible information that the medicinal product to be imported does not differ significantly from the medicinal product which is already authorised.

20When, in particular in the case of an importer, the applicant does not have access to all the necessary information but provides data that make it at least plausible that the two medicinal products do not differ significantly for the purpose of assessing their safety and efficacy, the competent authorities must act in such a way that their decision as to whether to extend to the second medicinal product the marketing authorisation granted to the first one is taken on the basis of the fullest information possible, including information which is available to them or which they could have obtained through cooperation with the health authorities in other Member States.

The answer to the question must therefore be that, in the case where

an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised,

the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation,

the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health,

Articles 28 EC et 30 EC preclude the application being rejected solely on the ground that the two medicinal products do not have a common origin.

Costs

22The costs incurred by the Commission, which has submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings pending before the national court, the decision on costs is a matter for that court.

On those grounds,

THE COURT (Sixth Chamber),

in answer to the question referred to it by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of 14 March 2002, hereby rules:

In the case where

an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised,

the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation,

the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health,

the application being rejected solely on the ground that the two medicinal products do not have a common origin.

Delivered in open court in Luxembourg on 1 April 2004.

Gulmann

Cunha Rodrigues

Puissochet

Schintgen

Macken

Registrar

President

Language of the case: German.