ddrg/super_eurlex huggingface dataset:
Case C-74/03

SmithKline Beecham plc

v

Lægemiddelstyrelsen

(Reference for a preliminary ruling from the Østre Landsret)

(Medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Active substance in different forms of salt – Additional documentation)

Opinion of Advocate General Jacobs delivered on 16 September 2004

Judgment of the Court (Second Chamber), 20 January 2005.

Summary of the Judgment

1. Approximation of laws – Medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Medicine containing the same therapeutic moiety as the reference product but combined with another salt – Whether permissible – Conditions

(Council Directive 65/65, Art. 4.8(a)(iii))

2. Approximation of laws – Medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Proof of similarity – Results of pharmacological and toxicological tests or clinical trials – Whether permissible

(Council Directive 65/65, Art. 4.8(a)(iii))

1. On a proper interpretation of Article 4.8(a)(iii) of Directive 65/65 on medicines, as amended by Directives 87/21, 89/341 and 93/39, which permits recourse to an abridged procedure for issuing marketing authorisations for medicines if the medicine for which such authorisation is applied for is essentially similar to a product which has been authorised within the Community, in accordance with Community provisions in force, for not less than six or ten years and is marketed in the Member State for which the application is made, such an application for authorisation may be handled under that abridged procedure where that product contains the same therapeutic moiety as the reference product but combined with another salt. There can be no such similarity if, for reasons specifically identified, there are grounds for believing that there is a significant difference from the reference medicine as regards the safety or efficacy of the product for which the marketing authorisation is sought.

(see paras 39, 44, operative part 1)

2. In support of an application under Article 4.8(a)(iii) of Directive 65/65 on medicines, as amended by Directives 87/21, 89/341 and 93/39, an applicant may, either spontaneously or at the request of the competent authority of a Member State, supply additional documentation in the form of certain pharmacological and toxicological tests or clinical trials in order to demonstrate that his product is essentially similar to the reference product.

(see para. 25, operative part 2)
Case C-181/03 P

Albert Nardone

v

Commission of the European Communities

(Appeal – Former official – Application for invalidity pension – Conditions for granting)

Opinion of Advocate General Poiares Maduro delivered on 29 June 2004

Judgment of the Court (First Chamber), 13 January 2005

Summary of the Judgment

Officials – Invalidity pension – Initiation of the invalidity procedure – Conditions

(Staff Regulations, Art. 78; Annex VIII, Art. 13)

It follows from the unequivocal provisions of Article 13 of Annex VIII to the Staff Regulations which lays down, in accordance with Article 78 of the Staff Regulations, the conditions on which an official is entitled to an invalidity pension, that the procedure to establish invalidity may be initiated only in relation to an official who is obliged to end his service with the Communities because he is suffering from an invalidity preventing him from performing his duties. It follows that an official who has left the service several years ago and who suffers from an illness which would render him incapable of performing his duties if he were still in active employment is not entitled to request, on that ground alone, the initiation of the procedure to establish invalidity.

(see paras 39-40)
Case C-472/03

Staatssecretaris van Financiën

v

Arthur Andersen & Co. Accountants c.s.

(Reference for a preliminary ruling from the Hoge Raad der Nederlanden)

(Sixth VAT directive – Article 13B(a) – Exemption of services related to insurance transactions by insurance brokers and insurance agents – Life assurance – ‘Back office’ activities)

Opinion of Advocate General Poiares Maduro delivered on 12 January 2005

Judgment of the Court (First Chamber), 3 March 2005

Summary of the Judgment

Tax provisions – Harmonisation of laws – Turnover taxes – Common system of value added tax – Exemptions provided for by the Sixth Directive – Exemption for services related to insurance transactions by insurance brokers and insurance agents – Meaning – ‘Back office’ activities consisting in assisting an insurance company in the performance of its activities – Excluded

(Council Directive 77/388, Art. 13B( a))

Article 13B(a) of Sixth Directive 77/388, relating to the exemption from value added tax of insurance and reinsurance transactions, including certain related services, must be interpreted as meaning that ‘back office’ activities, consisting in rendering services, for payment, to an insurance company, do not constitute the performance of services relating to insurance transactions carried out by an insurance broker or an insurance agent within the meaning of that provision.

Since, first, those services have specific aspects, such as the setting and payment of commission for insurance agents, the maintenance of contact with them, the handling of aspects relating to reinsurance and the supply of information to insurance agents and to the tax authorities, and, secondly, essential aspects of the work of an insurance agent, such as the finding of prospects and their introduction to the insurer are lacking, the activities in question must be regarded as a form of cooperation consisting in assisting an insurance company in the performance of activities which would normally be carried out by it, but without having a contractual relationship with the insured parties, and constitute a division of the activities of the insurance company and not the performance of services carried out by an insurance agent.

(see paras 35-36, 38-39, operative part)
Case C-32/03

I/S Fini H

v

Skatteministeriet

(Reference for a preliminary ruling from the Højesteret)

(Sixth VAT Directive – Status of taxable person – Right to deduct – Winding up – Direct and immediate link – Transactions forming part of the economic activity as a whole)

Opinion of Advocate General Jacobs delivered on 28 October 2004

Judgment of the Court (Third Chamber), 3 March 2005

Summary of the Judgment

Tax provisions – Harmonisation of laws – Turnover taxes – Common system of value added tax – Economic activities within the meaning of Article 4 of the Sixth Directive – Taxable person – Meaning – Person having ceased an economic activity but continuing to pay rent and charges relating to premises previously used for that activity owing to the impossibility of surrendering the lease – Included – Benefit of a right to a deduction – Conditions

(Council Directive 77/388, Art. 4 (1) to (3))

Article 4(1) to (3) of Sixth Directive 77/388 on the harmonisation of the laws of the Member States relating to turnover taxes is to be interpreted as meaning that a person who has ceased an economic activity but who, because the lease contains a non-termination clause, continues to pay the rent and the charges on the premises used for that activity, is to be regarded as a taxable person within the meaning of that article and is entitled to deduct the value added tax on the amounts thus paid, provided that there is a direct and immediate link between the payments made and the economic activity and that the absence of any fraudulent or abusive intent has been established.

Transactions such as the payments which a person continues to make during the period over which their business was wound up must be regarded as forming part of the economic activity within the meaning of Article 4 of the Sixth Directive. Moreover, there is a direct and immediate link between the obligation to continue to pay the rent and other charges after the economic activity has ceased and the carrying on of that activity, since the lease was entered into in order to have the premises available which were necessary for carrying on that activity, which was actually carried on there. The duration of the obligation to pay the rent and the charges on those premises has, in that respect, no bearing, provided that that period of time is strictly necessary to complete the winding-up of the business.

(see paras. 24, 26, 28-29, 35, operative part)
Judgment of the Court (First Chamber) of 23 February 2006 – Commission v Finland

(Case C-232/03)

Failure of a Member State to fulfil obligations – Workers – Freedom of movement – Use of vehicles registered abroad and made available to the worker by the employer residing abroad

Freedom of movement for workers – Workers – Restrictions (Art. 39 EC) (see paras 49-52, 55, operative part 1)

Re:

Failure of a Member State to fulfil obligations – Articles 10 EC and 39 EC – Conditions for the use by workers residing in Finland and employed abroad of vehicles registered abroad and made available to them by the employer

Operative part:

The Court:

1. Declares that, by preventing cross-frontier workers residing in Finland and employed in another Member State from benefiting from the use of company vehicles which are made available by their employers established in another Member State and registered in the latter State on the sole ground that the cross-frontier workers concerned reside on Finnish territory, into which the vehicles belonging to their employers have been imported,

and

by preventing the cross-frontier workers concerned from benefiting, for professional and private purposes, from the use of company vehicles which are made available by their employers established in another Member State and registered in the latter State, while those vehicles are neither intended to be used mainly in Finland on a permanent basis nor, in fact, used in that way, on the sole ground that those workers reside on Finnish territory, into which the vehicles belonging to their employers have been imported,

the Republic of Finland has failed to fulfil its obligations under Article 39 EC;

2. Dismisses the remainder of the application;

3. Orders each party to bear its own costs;
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1. Environment — Freedom of access to information — Directive 90/313 — Request for information — Two-month time-limit for a reply imposed on the public authority — Mandatory

(Council Directive 90/313, Art. 3(4))

2. Environment — Freedom of access to information — Directive 90/313 — Implied decision to refuse a request for information — No reasons given at the end of the two-month period for response — Unlawfulness of the decision

(Council Directive 90/313, Art. 3(4) and 4)

3. Environment — Freedom of access to information — Directive 90/313 — Judicial protection — Decision which may be open to review — Implied refusal of a request for information

(Council Directive 90/313, Art. 4)

Summary

1. The two-month time-limit within which the public authority must reply to the request for access to information laid down in Article 3(4) of Directive 90/313 on the freedom of access to information on the environment is mandatory.

(see para. 29, operative part 1)

2. Article 3(4) of Directive 90/313 on the freedom of access to information on the environment, in conjunction with Article 4 thereof, does not preclude national legislation according to which, for the purposes of granting effective judicial protection, the failure of a public authority to respond within a period of two months is deemed to give rise to an implied refusal which may be the subject of a judicial or administrative review in accordance with the national legal system. However, by virtue of Article 3(4) it is unlawful for such a decision not to be accompanied by reasons when the two-month time-limit expires. In those circumstances, the implied refusal must be regarded as unlawful.

(see para. 36, operative part 3)

3. The decision referred to in Article 4 of Directive 90/313 on the freedom of access to information on the environment, against which a judicial or administrative review may be sought by the person who made the request for information, is the implied refusal which arises from the failure by the public authority competent to decide on that request to respond within two months.

(see para. 39, operative part 2)
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Agriculture — Common organisation of the markets — Poultrymeat — Marketing standards — Regulation of indications concerning the type of farming on labelling — Prohibition on including the wording ‘reared under controlled conditions’ on the labelling of products

(Commission Regulation No 1538/91, Art. 10(1))

Summary

Article 10(1) of Regulation No 1538/91 introducing detailed rules for implementing Regulation No 1906/90 on certain marketing standards for poultrymeat, as amended by Regulation No 1321/2002, must be interpreted as meaning that the wording ‘reared under controlled conditions’ (‘kontrollierte Aufzucht’) constitutes an indication of the type of farming and for that reason that article does not allow an undertaking to include that wording on the labelling of a product falling within the scope of that regulation.

(see para. 17, operative part)
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1. Community law — Principles — Equal treatment — Discrimination on grounds of nationality — Prohibited — Scope — Copyright and related rights — Included

(Art. 12 EC)

2. Community law — Principles — Equal treatment — Discrimination on grounds of nationality — Prohibited — Copyright protection afforded by the law of a Member State subject to a distinguishing criterion based on the country of origin of the work — Not permissible

(Art. 12 EC)

Summary

1. Copyright and related rights, which by reason in particular of their effects on intra-Community trade in goods and services fall within the scope of application of the EC Treaty, are necessarily subject to the general principle of non-discrimination laid down by the first paragraph of Article 12 EC.

(see para. 18)

2. Article 12 EC, which lays down the general principle of non discrimination on grounds of nationality, must be interpreted as meaning that the right of an author to claim in a Member State the copyright protection afforded by the law of that State may not be subject to a distinguishing criterion based on the country of origin of the work.

(see para. 36, operative part)
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Approximation of laws — Trade marks — Directive 89/104 — Right of the proprietor of a registered trade mark to contest its unlawful use — Sign used for identical or similar goods — Likelihood of confusion –– Criteria for assessment –– Juxtaposing the company name of another party and a registered mark

(Council Directive 89/104, Art. 5(1)(b))

Summary

Article 5(1)(b) of First Directive 89/104 relating to trade marks is to be interpreted as meaning that where the goods or services are identical there may be a likelihood of confusion on the part of the public where the contested sign is composed by juxtaposing the company name of another party and a registered mark which has normal distinctiveness and which, without alone determining the overall impression conveyed by the composite sign, still has an independent distinctive role therein.

(see para. 37, operative part)
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Freedom of movement for persons – Workers – Equal treatment

(Art. 39 EC)

Summary

Article 39 EC is to be interpreted as meaning that, where national legislation concerning the allocation of parental benefits applies, which requires a worker to have been affiliated to a sickness insurance scheme for a certain minimum period for the calculation of the amount of those benefits, the period during which a worker was affiliated to the Joint Sickness Insurance Scheme of the European Communities must be taken into account.

(see para. 26, operative part)
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1. Free movement of capital – Restrictions

(Arts 56 EC and 58 EC)

2. Free movement of capital – Restrictions

(Arts 56 EC and 58 EC)

Summary

1. Articles 56 EC and 58 EC must be interpreted as precluding national legislation which provides that a payment in respect of a share repurchase to a non-resident shareholder in connection with a reduction in share capital is taxed as a dividend without there being a right to deduct the cost of acquisition of those shares, whereas the same payment made to a resident shareholder is taxed as a capital gain with a right to deduct the cost of acquisition.

The effect of such legislation is to make cross-frontier transfer of capital less attractive both by deterring investors who are not resident in that Member State from buying shares in companies resident in that Member State and also, consequently, by restricting the opportunities available to such companies to raise capital from investors who are not resident in that Member State.

Since the cost of acquisition is directly linked to the payment made on the occasion of a share repurchase, there is no objective difference between the situations of residents and non-residents such as to justify different treatment on this point.

(see paras 34, 40, 43, operative part 1)

2. Articles 56 EC and 58 EC must be interpreted as precluding national legislation deriving from a double taxation agreement which fixes a lower ceiling on the taxation of dividends for non-resident shareholders than for resident shareholders, and, by interpreting that agreement in the light of the commentaries of the OECD on its applicable model convention in the context of the taxation of a share repurchase payment in connection with a reduction in share capital, permits the nominal value of such shares to be deducted from the share repurchase payment, whereas a resident shareholder is permitted to deduct the cost of acquisition of shares, except where, under such national legislation, non-resident shareholders are not treated less favourably than resident shareholders. It is for the national court to determine whether that is the case.

(see paras 53, 56, operative part 2)
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Tax provisions – Harmonisation of laws – Taxes other than turnover taxes which affect the consumption of manufactured tobacco

(Council Directive 95/59, Art. 7(2))

Summary

Article 7(2) of Directive 95/59 on taxes other than turnover taxes which affect the consumption of manufactured tobacco must be interpreted as meaning that cigarettes without tobacco which do not contain substances having a medical effect but which are presented and marketed as an aid to giving up smoking are not ‘used exclusively for medical purposes’ within the meaning of the second subparagraph of that provision.

Considerations linked to the presentation, marketing or perception of a product are not, by themselves, enough to qualify that product for the derogation laid down in the second subparagraph of Article 7(2) of Directive 95/59.

(see paras 32, 35, operative part)
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1. Competition – Administrative procedure – Request for information – Powers of the Commission

(Council Regulation No 17, Art. 11)

2. Competition – Fines – Amount – Determination – Criteria – Reduction of the amount of the fine in exchange for the cooperation of the undertaking involved with the Commission

(Council Regulation No 17, Art. 15(2); Commission Notice 96/C 207/04, Section D, para. 2)

Summary

1. Regulation No 17 does not give an undertaking which is being investigated under that regulation any right to evade the investigation. The undertaking in question is, on the contrary, subject to an obligation to cooperate actively, which implies that it must make available to the Commission all information relating to the subject‑matter of the investigation.

So far as concerns the question whether that obligation also applies to requests for information which could be used to establish, against the undertaking which provides the information, an infringement of the competition rules, it is established that in order to ensure the effectiveness of Article 11(2) and (5) of Regulation No 17, the Commission is entitled to compel an undertaking to provide all necessary information concerning such facts as may be known to it and to disclose to it, if necessary, such documents relating thereto as are in that undertaking’s possession, even if the latter may be used to establish, against it or another undertaking, the existence of anti-competitive conduct.

That obligation to cooperate means that the undertaking may not evade requests for production of documents on the ground that by complying with them it would be required to give evidence against itself.

Finally, while it is evident that the rights of the defence should be respected, the undertaking concerned is still able, either during the administrative procedure or in the proceedings before the Community Courts, to contend that the documents produced have a different meaning from that ascribed to them by the Commission.

(see paras 40-41, 48-49)

2. A reduction under the Notice on the non-imposition or reduction of fines in cartel cases can be justified only where the information provided and, more generally, the conduct of the undertaking concerned might be considered to demonstrate a genuine spirit of cooperation on its part.

The conduct of an undertaking which, although it was not obliged to answer a question asked by the Commission, did answer it, but in an incomplete and misleading way, cannot be considered to reflect such a spirit of cooperation.

(see paras 68-69)
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Free movement of goods – Customs duties – Charges having equivalent effect – Internal taxation

(Arts 23 EC, 25 EC and 90 EC)

Summary

A charge levied by an association governed by public law of a Member State, on the basis of identical criteria, on national products intended for the national market or for export to other Member States constitutes a charge having an effect equivalent to an export duty, prohibited by Articles 23 EC and 25 EC, if the revenue from that charge is used to finance activities which benefit only the national products intended for the national market and the advantages stemming from the use of the revenue from that charge fully offset the burden borne by those products. On the other hand, if the advantages accruing to the national products processed or marketed on the national market from the use of the revenue generated by that charge offset only partially the burden borne by those products, such a charge constitutes a breach of the prohibition on discrimination laid down by Article 90 EC.

(see para. 28, operative part)
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1. Approximation of laws – Telecommunications sector – Common framework for general authorisations and individual licences – Directive 97/13

(European Parliament and Council Directive 97/13)

2. Approximation of laws – Telecommunications sector – Common framework for general authorisations and individual licences – Directive 97/13

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

Summary

1. Directive 97/13 on a common framework for general authorisations and individual licences in the field of telecommunications services applies, in principle, not only to public telecommunication networks and services but also to private telecommunication networks which have not been opened to the public and are reserved to a closed group of users, and to services provided on those private networks.

(see para. 28)

2. Article 11 of Directive 97/13 on a common framework for general authorisations and individual licences in the field of telecommunications services precludes a national provision which requires the holder of an individual licence for the provision of a public telecommunications network, for which it has paid a fee as provided for in that article, to pay an additional fee in respect of the private use of that network calculated in accordance with criteria which do not correspond to those laid down in that article.

Member States may not levy any fees or charges in relation to authorisation procedures other than those provided for by Directive 97/13.

(see paras 35, 38, operative part)