ddrg/super_eurlex huggingface dataset:
Keywords

Summary



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Approximation of laws – Medicinal products – Marketing authorisation – Hybrid abridged procedure – Reference medicinal product when considering application for authorisation – Right of competent authority to refer to the new pharmaceutical form of a product which has been authorised within the Community for at least 6 or 10 years

(European Parliament and Council Directive 2001/83, Art. 10(1)(a)(iii))

Summary

An application for marketing authorisation for a Product C may be made under the hybrid abridged procedure established under Article 10(1)(a)(iii) of Directive 2001/83/EC on the Community code relating to medicinal products for human use where the application seeks to demonstrate that Product C is essentially similar to a Product B, in circumstances where Product B is a new pharmaceutical form of Product A, and Product A, but not Product B, has been authorised for marketing in the Community for at least the 6 or 10 year period stipulated therein.

(see para. 30, operative part)
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Convention on Jurisdiction and the Enforcement of Judgments – Relationship with other conventions – Conventions relating to a particular field – Convention containing rules on jurisdiction – Jurisidiction of the court seised challenged by the defendant on the basis of such a convention – Compliance by the court seised, in accordance with Article 57 of the Brussels Convention, with the rules of jurisdiction of the specialised convention

(Brussels Convention of 27 September 1968, Arts 20 and 57(2)(a))

Summary

Article 57(2)(a) of the Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters, as amended by the Convention of 9 October 1978 on the Accession of the Kingdom of Denmark, Ireland and the United Kingdom of Great Britain and Northern Ireland, by the Convention of 25 October 1982 on the Accession of the Hellenic Republic, by the Convention of 26 May 1989 on the Accession of the Kingdom of Spain and the Portuguese Republic and by the Convention of 29 November 1996 on the Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden, should be interpreted as meaning that the court of a Contracting State in which a defendant domiciled in another Contracting State is sued may derive its jurisdiction from a specialised convention to which the first State is a party as well and which contains specific rules on jurisdiction, even where the defendant, in the course of the proceedings in question, submits no pleas on the merits and formally contests the jurisdiction of the court seised.

In that connection, although it is true that according to Article 20 of the Convention of 27 September 1968, applicable by virtue of the second sentence of Article 57(2)(a), the court in question is required to declare of its own motion that it has no jurisdiction unless its jurisdiction was derived from the terms of that convention, the jurisdiction of that court must, however, be regarded as derived from the Convention, because Article 57 thereof specifically states that the rules of jurisdiction laid down by specialised conventions are not affected by that convention.

In those circumstances, when verifying of its own motion whether it has jurisdiction with respect to that convention, the court of a Contracting State in which a defendant domiciled in another Contracting State is sued and fails to enter an appearance must take account of the rules of jurisdiction laid down by specialised conventions to which the first Contracting State is also a party.

(see paras 16-20, operative part)
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Summary



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1. Social policy – Approximation of laws – Collective redundancies – Directive 98/59 – Concept of collective redundancy – Event constituting redundancy

(Council Directive 98/59, Arts 2 to 4)

2. Social policy – Approximation of laws – Collective redundancies – Directive 98/59 – Consultation and notification procedures – Obligation on an employer not to carry out redundancies before the end of the consultation procedure and before the competent authorities have been notified

(Council Directive 98/59, Arts 2 to 4)

Summary

1. Articles 2 to 4 of Directive 98/59 on the approximation of the laws of the Member States relating to collective redundancies, which impose obligations on employers as to consultation and notification, must be construed as meaning that the event constituting redundancy consists in the declaration by an employer of his intention to terminate the contract of employment, the actual cessation of that relationship on the expiry of the period of notice being no more than the effect of the decision to carry out the redundancy.

(see paras 36, 39, operative part 1)

2. An employer is entitled to carry out collective redundancies after the conclusion of the consultation procedure provided for in Article 2 of Directive 98/59 on the approximation of the laws of the Member States relating to collective redundancies and after notification of the projected collective redundancies as provided for in Articles 3 and 4 of that directive.

(see para. 54, operative part 2)
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Social policy – Men and women – Equal treatment in occupational social security schemes – Directive 86/378 – Supplementary occupational pension scheme – Provisions having the effect of suspending the acquisition of pension rights during maternity leave – Not permissible

(Council Directive 86/378, as amended by Directive 96/97, Art. 6(1)(g))

Summary

Article 6(1)(g) of Directive 86/378 on the implementation of the principle of equal treatment for men and women in occupational social security schemes, as amended by Directive 96/97, must be interpreted as meaning that it precludes national rules under a woman acquires no rights to an insurance annuity which is part of a supplementary occupational pension scheme during statutory maternity leave paid in part by her employer because the acquisition of those rights is conditional upon the woman’s receiving taxable pay during the maternity leave.

(see para. 35, operative part)
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Summary



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Approximation of laws – Protection of consumers in respect of distance contracts – Directive 97/7 – Scope – Exemptions provided for under Article 3(2) – Contracts for the provision of transport services – Meaning – Contracts for the provision of car hire services – Included

(Parliament and Council Directive 97/7, Art. 3(2))

Summary

Article 3(2) of Directive 97/7 on the protection of consumers in respect of distance contracts is to be interpreted as meaning that ‘contracts for the provision of transport services’ can cover all contracts governing services in the field of transport, including those involving an activity which does not include, as such, the carriage of the customer or his goods, but which is aimed at enabling the customer to perform that carriage. That concept thus includes contracts for the provision of car hire services the essential nature of which is the making available to the consumer of a means of transport.

(see paras 23, 27, 31, operative part)
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1. Free movement of goods — Quantitative restrictions — Measures having equivalent effect — Medicinal products — Prior authorisation procedure on the importation of personal imports, not effected by personal transport, of medicinal products lawfully prescribed in the Member State into which they are imported and authorised both in that Member State and in the Member State of origin — Not permissible

(Art. 28 EC; Council Directive 65/65)

2. Free movement of goods — Quantitative restrictions — Measures having equivalent effect — Medicinal products — Prior authorisation procedure on personal imports, not effected by personal transport, of homeopathic medicinal products lawfully prescribed in the Member State into which they are imported and registered in another Member State — Not permissible

(Art. 28 EC; Council Directive 92/73)

3. Free movement of goods — Quantitative restrictions — Measures having equivalent effect — Medicinal products — Prior authorisation procedure on personal imports, not effected by personal transport, of medicinal products lawfully prescribed in the Member State into which they are imported and not authorised in that Member State but only in the Member State of origin, identical to the procedure applicable to medicinal products imported for commercial purposes — Not permissible

(Art. 28 EC)

Summary

1. A Member State fails to fulfil its obligations under Article 28 EC by applying a prior authorisation procedure to personal imports, not effected by personal transport, of medicinal products lawfully prescribed in that Member State and authorised both in the latter and in the Member State where they are purchased, under Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.

(see para. 49, operative part)

2. A Member State fails to fulfil its obligations under Article 28 EC by applying a prior authorisation procedure to personal imports, not effected by personal transport, of homeopathic medicinal products lawfully prescribed in that Member State and registered in another Member State pursuant to Directive 92/73 widening the scope of Directives 65/65 and 75/319 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products.

(see para. 49, operative part)

3. A Member State fails to fulfil its obligations under Article 28 EC by applying a disproportionate prior authorisation procedure to personal imports, not effected by personal transport, of medicinal products lawfully prescribed in that Member State and not authorised in the latter but only in the Member State where they are purchased, namely the same authorisation procedure to those imports as it does to medicinal products imported for commercial purposes.

(see paras 42, 49, operative part)
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Freedom of movement for persons — Workers — Equal treatment — Access to employment — Competition for the recruitment of the teaching staff in the State schools of a Member State — Failure to take account of or insufficient account taken of professional experience acquired in other Member States — Inadmissible

(Art. 39 EC; Council Regulation No 1612/68, Art. 3(1))

Summary

A Member State which does not take into account or, at least, does not take into account in the same way, for the purposes of participation of Community nationals in recruitment competitions for teaching staff in national State schools, professional teaching experience acquired by those nationals, depending on whether the teaching was carried out in that Member State or in other Member States, fails to fulfil its obligations under Article 39 EC and Article 3(1) of Regulation No 1612/68 on freedom of movement for workers within the Community.

(see para. 22, operative part)
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Approximation of laws — Telecommunications sector –– Common framework for general authorisations and individual licences –– Directive 97/13 –– Fees and charges applicable to undertakings holding individual licences –– Optimal use of scarce resources –– Imposition of a charge on new operators in respect of the allocation of telephone numbers –– Not permissible

(Directive of the European Parliament and of the Council 97/13, Art. 11(2))

Summary

Article 11(2) of Directive 97/13 on a common framework for general authorisations and individual licences in the field of telecommunications services allows the application of a charge on undertakings to manage a ‘scarce resource’ in an optimal manner, in so far as that charge is non-discriminatory and takes into account the need to foster the development of innovative services and competition.

That provision must be interpreted as precluding national legislation which provides that a new operator on the telecommunications market is required to pay a charge in respect of the allocation of telephone numbers taking account of their economic value, where a telecommunications undertaking having a dominant position on the same market took over free of charge the very large stock of numbers which were available to its predecessor, the former monopoly, and national law precludes retrospective payment of such a charge in respect of that stock.

(see paras 21, 23, 46, operative part)
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Free movement of capital – Restrictions

(EC Treaty, Art. 73b (now Art. 56 EC))

Summary

Article 73b of the Treaty (now Article 56 EC) is to be interpreted as meaning that it does not preclude legislation of a Member State by which the estate of a national of that Member State who dies within 10 years of ceasing to reside in that Member State is to be taxed as if that national had continued to reside in that State, while enjoying relief in respect of inheritance taxes levied by other States.

By enacting identical taxation provisions for the estates of nationals who have transferred their residence abroad and of those who have remained in the Member State concerned, such legislation cannot discourage the former from making investments in that Member State from another State nor the latter from doing so in another Member State from the Member State concerned, and, regardless of the place where the assets in question are situated, nor can it diminish the value of the estate of a national who has transferred his residence abroad.

The differences in treatment between residents who are nationals of the Member State concerned and those who are nationals of other Member States resulting from such legislation flow, in the absence of any unifying or harmonising measures adopted in the Community context, from the Member States’ power to define, by treaty or unilaterally, the criteria for allocating their powers of taxation.

Moreover, national legislation which would discourage a national who wishes to transfer his residence to another State, and thus hinder his freedom of movement, cannot for that reason alone constitute a restriction on the movement of capital within the meaning of Article 73b of the Treaty.

(see paras 46-47, 50-51, operative part)
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Competition – Community rules – Undertaking – Definition

(Arts 81 EC and 82 EC)

Summary

In Community competition law, the definition of an ‘undertaking’ covers any entity engaged in an economic activity, regardless of its legal status and the way in which it is financed.

In that connection, it is the activity consisting in offering goods and services on a given market that is the characteristic feature of an economic activity so that there is no need to dissociate the activity, of purchasing goods from the subsequent use to which they are put in order to determine the nature of that purchasing activity.

(see paras 25-26)
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1. Environment – Assessment of the effects of certain projects on the environment – Directive 85/337

(Council Directive 85/337, Art. 1(2))

2. Environment – Assessment of the effects of certain projects on the environment – Directive 85/337

(Council Directive 85/337, Arts 1(2), 2(1), and 4(2))

Summary

1. Article 1(2) of Directive 85/337 on the assessment of the effects of certain public and private projects on the environment defines ‘development consent’ for the purposes of the directive as the decision of the competent authority or authorities which entitles the developer to proceed with the project.

That term, which is a Community concept, refers to the decision which allows the developer to commence the works for carrying out his project.

(see paras 39-41, 45, operative part 1)

2. According to Article 2(1) of Directive 85/337 on the assessment of the effects of certain public and private projects on the environment, projects likely to have significant effects on the environment, as referred to in Article 4 of the directive read in conjunction with Annexes I and II thereto, must be made subject to an assessment with regard to their effects before development consent is given.

Where national law provides for a consent procedure comprising more than one stage, one involving a principal decision and the other involving an implementing decision which cannot extend beyond the parameters set by the principal decision, the effects which a project may have on the environment must, as a rule, be identified and assessed at the time of the procedure relating to the principal decision. If those effects are not, however, identifiable until the time of the procedure relating to the implementing decision, the assessment is to be carried out in the course of that procedure.

It follows that Articles 2(1) and 4(2) of Directive 85/337, which impose the obligation on the Member States to carry out environmental impact assessments, are to be interpreted as requiring such an assessment to be carried out if, in the case of grant of consent comprising more than one stage, it becomes apparent, in the course of the second stage, that the project is likely to have significant effects on the environment by virtue inter alia of its nature, size or location.

(see paras 43, 47, 49, operative part 2)
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Actions for failure to fulfil obligations – Proof of failure – Burden of proof on the Commission

(Art. 226 EC)

Summary

Without prejudice to the obligation of the Member States, under Article 10 EC, to facilitate the achievement of the Commission’s tasks, which consist in particular, pursuant to Article 211 EC, in ensuring that the provisions of the Treaty and the measures taken by the institutions pursuant thereto are applied, in an action for failure to fulfil obligations it is incumbent upon the Commission to prove the allegation that the obligation has not been fulfilled. It is the Commission’s responsibility to place before the Court the information needed to enable the Court to establish that the obligation has not been fulfilled, and in so doing the Commission may not rely on any presumption.

Thus, in an action for a declaration that for one public body, without prior advertising, to provide another with emergency ambulance services is contrary to freedom of establishment and the freedom to provide services, it is for the Commission to place before the Court the information needed to enable the Court to establish that a public contract has been awarded, given that the possibility that the public body concerned provides the services in question in the exercise of its own powers cannot be excluded. In that regard, the mere fact that, as between two public bodies, funding arrangements exist in respect of emergency ambulance services does not imply that the provision of the services concerned constitutes an award of a public contract which would need to be assessed in the light of the fundamental rules of the Treaty.

(see paras 28-29, 36-37)
Keywords

Subject of the case

Operative part



Keywords

Agriculture – EAGGF – Clearance of accounts (see para. 47)

2. Agriculture – Common agricultural policy – Integrated administration and control system for certain aid schemes (Commission Regulation No 3887/92, amended by Regulation No 2801/1999, Art. 6(5) (see paras 60-61)

3. Agriculture – Common agricultural policy – Integrated administration and control system for certain aid schemes (Commission Regulation No 3887/92, amended by Regulation No 2801/1999, Art. 9) (see paras 84-89)

Subject of the case

Re:

Partial annulment of Commission Decision 2003/102/EC of 14 February 2003 excluding from Community financing certain expenditure incurred by the Member States under the Guarantee Section of the European Agricultural Guidance and Guarantee Fund (EAGGF) (notified under document number C(2003) 500) (OJ 2003 L 42, p. 47) – Checks in the arable crops sector – Case of the Land of Brandenburg

Operative part

Operative part:

The Court:

1) Dismisses the action;

2) Orders the Federal Republic of Germany to pay the costs.
Case C-213/03

Syndicat professionnel coordination des pêcheurs de l’étang de Berre and de la région

v

Électricité de France (EDF)

(Reference for a preliminary ruling from the Cour de cassation (France))

(Convention for the Protection of the Mediterranean Sea against Pollution (Barcelona Convention) – Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources – Article 6(3) – Authorisation to discharge – Direct effect)

Summary of the Judgment

1. International agreements – Community Agreements – Direct effect – Conditions – Article 6(3) of the Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources and Article 6(1) of the amended Protocol – Obligation on Member States to subject the discharge of certain substances to a system of authorisation

(Art. 6(3) of the Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources, and Art. 6(1) of the amended Protocol)

2. International agreements – Community Agreements – Article 6(3) of the Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources and Article 6(1) of the amended Protocol – Discharge of non-toxic substances – Prohibition without prior authorisation

(Art. 6(3) of the Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources, and Art. 6(1) of the amended Protocol)

1. A provision in an agreement concluded by the Community with a non‑member country must be regarded as being directly applicable when, regard being had to its wording and to the purpose and nature of the agreement, the provision contains a clear and precise obligation which is not subject, in its implementation or effects, to the adoption of any subsequent measure.

Such is the case with Article 6(3) of the Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources and Article 6(1) of the amended Protocol which clearly, precisely and unconditionally lay down the obligation for Member States to subject discharges of the substances listed in Annex II to the Protocol to the issue by the competent national authorities of an authorisation taking due account of the provisions of Annex III. As a result, since those provisions have direct effect, any interested party is entitled to rely on them before the national courts.

(see paras 39, 41, 47, operative part 1)

2. Article 6(3) of the Protocol for the Protection of the Mediterranean Sea against Pollution from Land-based Sources and Article 6(1) of the amended Protocol must be interpreted as prohibiting, without an authorisation issued by the competent national authorities, the discharge of substances which, although not toxic, have an adverse effect on the oxygen content of the marine environment, since those provisions do not expressly make the requirement of prior authorisation conditional on their toxicity.

(see paras 49, 52, operative part 2)
Case C-375/03

Commission of the European Communities

v

Grand Duchy of Luxembourg

(Failure of a Member State to fulfil obligations – Failure to implement Directive 2000/30/EC)

Summary of the Judgment

Actions for failure to fulfil obligations – Examination of the merits by the Court – Situation to be taken into consideration – Situation at the end of the period laid down in the reasoned opinion

(Art. 226 EC)