ddrg/super_eurlex huggingface dataset:
8.

Liability for defective medicinal products administered to humans is governed by another legal act, that is to say, the Arzneimittelgesetz vom 24 August 1976 ( 4 ) (Law on medicinal products of 24 August 1976; ‘the AMG’). Under Paragraph 84 of the AMG in the version applicable in the main proceedings: ‘1. If, as a result of having been administered a medicinal product intended for human use, a person dies or the body or health of a person is adversely affected to a substantial degree, the pharmaceutical undertaking which placed the medicinal product on the market under the present Law shall be required to compensate the injured party for the resulting damage, where the product at issue has been supplied to the consumer under the present Law and is subject to compulsory marketing authorisation or has been exempted by regulation from that requirement. Liability to provide compensation shall apply only where: (1) when used as intended, the medicinal product has harmful effects in excess of what is considered acceptable in the light of current medical knowledge; or (2) the damage has occurred as a result of labelling, or specialist information or instructions for use which do not reflect current medical knowledge. 2. If, in the circumstances of an individual case, the medicinal product administered is capable of causing the damage, a presumption shall arise to the effect that the damage was caused by that medicinal product. In each case, the question whether the medicinal product is capable of causing the damage shall be determined in the light of the product’s composition and the dosage administered, the intended manner and duration of use, the relationship in time between the dose administered and the damage, the nature of the damage and the state of health of the person adversely affected at the time when the product was administered and all other circumstances which, in the individual case, suggest that the product did, or did not, cause the damage. That presumption shall not apply if, in the circumstances of an individual case, the damage may well be attributable to a different factor. However, the administration of additional medicinal products capable, in the circumstances of the individual case, of causing the damage concerned shall not be considered to constitute such a factor unless, in relation to the administration of those medicinal products, no claims may be brought under this provision for reasons other than the lack of causality. 3. Where the circumstances indicate that the damaging effect of the medicinal product is not attributable to its development or manufacturing process, the pharmaceutical undertaking shall not be liable under point 1 of the second sentence of subparagraph 1.’
14.

The request for a preliminary ruling, made pursuant to Article 267 TFEU, which was received at the Court Registry on 25 September 2013; refers the following questions for a preliminary ruling: ‘(1) In proceedings relating to an administrative decision adopted when Directive 2003/55/EC … was in force, do the provisions laid down in Article 25 of that directive, determining who is entitled to bring an action, apply, or are the provisions to be taken into consideration for the purposes of those proceedings laid down in Article 41 of Directive 2009/73/EC … which entered into force during the proceedings, account being taken of the second subparagraph of Article 54(1) of that directive, under which those provisions are to be applicable from 3 March 2011? (2) In the event that the 2009 Directive is applicable, can an approved vendor with a financial interest comparable to the interest at stake in the present proceedings, in relation to an action contesting the decision approving a network code or determining its content, be regarded as “a party affected” for the purposes of Article 41(17) of that directive, or can only the network manager who is authorised to seek approval of the code be regarded as “a party affected”? (3) In the event that the 2003 Directive is applicable, does the approval or amendment of the network code, such as that which has taken place in the present case, fall within the situations contemplated in Articles 25(5) and (6), in as much as it refers to the assessment of requests for reserve capacity? (4) In the event that the case falls within one of the situations contemplated in Article 25(6) of the 2003 Directive, can an approved vendor with a financial interest comparable to the interest at stake in the present proceedings, in relation to an action contesting the decision approving a network code or determining its content, be regarded as “a party affected” for the purposes of Article 41(17) of that directive, or can only the network manager who is authorised to seek approval of the code be regarded as “a party affected”? (5) What interpretation is to be given to Article 25(11) of the 2003 Directive, in accordance with which the claims referred to in Article 25(5) and (6) are to be without prejudice to the exercise of rights of appeal under Community and national law, in the event that it is apparent from the answers to the preceding questions that national law makes the bringing of an action subject to more stringent requirements than those laid down in the directive or in Community law?’
52.

Having regard to all of the above considerations, I suggest that the Court should answer the Cour d’appel de Mons as follows: Article 13A(1)(g) of the Sixth Council Directive 77/388/EEC of 11 May 1977 on the harmonisation of legislation of Member States concerning turnover taxes — Common system of value added tax: uniform basis of assessment, should be interpreted as meaning that a serviced residence, such as that at issue in the main proceedings, which offers persons of at least 60 years of age accommodation enabling them to live independently, together with chargeable related services, also available to non-residents, and which does not have the benefit of any financial assistance from the State, can be characterised as an ‘organisation recognised as charitable’ and regarded as supplying services ‘closely linked to welfare’, within the meaning of that provision. It will be for the national court to determine: — whether, having regard to the company objects of the serviced residence in question and the nature of the services it offers, this characterisation exceeds the discretion which that provision grants to Member States for the purposes of such characterisation; — whether the activities of the serviced residence fall within the scope of welfare. In this regard, it must take account of a combination of factors enabling it to be determined whether those activities are intended to assist persons in need; and — whether the services offered by the serviced residence are essential to the pursuit of such activities.
6.

Thus, Third Directive 78/855 provided as follows: ‘… Article 13 1. The laws of the Member States must provide for an adequate system of protection of the interests of creditors of the merging companies whose claims antedate the publication of the draft terms of merger and have not fallen due at the time of such publication. 2. To this end, the laws of the Member States shall at least provide that such creditors shall be entitled to obtain adequate safeguards where the financial situation of the merging companies makes such protection necessary and where those creditors do not already have such safeguards. 3. Such protection may be different for the creditors of the acquiring company and for those of the company being acquired. Article 14 Without prejudice to the rules governing the collective exercise of their rights, Article 13 shall apply to the debenture holders of the merging companies, except where the merger has been approved by a meeting of the debenture holders, if such a meeting is provided for under national laws, or by the debenture holders individually. Article 15 Holders of securities, other than shares, to which special rights are attached must be given rights in the acquiring company at least equivalent to those they possessed in the company being acquired, unless the alteration of those rights has been approved by a meeting of the holders of such securities, if such a meeting is provided for under national laws, or by the holders of those securities individually, or unless the holders are entitled to have their securities repurchased by the acquiring company. … Article 19 1. A merger shall have the following consequences ipso jure and simultaneously: (a) the transfer, both as between the company being acquired and the acquiring company and as regards third parties, to the acquiring company of all the assets and liabilities of the company being acquired; (b) the shareholders of the company being acquired become shareholders of the acquiring company; (c) the company being acquired ceases to exist. 2. No shares in the acquiring company shall be exchanged for shares in the company being acquired held either: (a) by the acquiring company itself or through a person acting in his own name but on its behalf; (b) by the company being acquired itself or through a person acting in his own name but on its behalf. 3. The foregoing shall not affect the laws of Member States which require the completion of special formalities for the transfer of certain assets, rights and obligations by the acquired company to be effective as against third parties. The acquiring company may carry out these formalities itself; however, the laws of the Member States may permit the company being acquired to continue to carry out these formalities for a limited period which cannot, save in exceptional cases, be fixed at more than six months from the date on which the merger takes effect. …’
9.

Article 3 of the Dublin III Regulation, entitled ‘Access to the procedure for examining an application for international protection’, reads as follows: ‘1. Member States shall examine any application for international protection by a third-country national … The application shall be examined by a single Member State, which shall be the one which the criteria set out in Chapter III indicate is responsible. 2. Where no Member State responsible can be designated on the basis of the criteria listed in this Regulation, the first Member State in which the application for international protection was lodged shall be responsible for examining it. Where it is impossible to transfer an applicant to the Member State primarily designated as responsible because there are substantial grounds for believing that there are systemic flaws in the asylum procedure and in the reception conditions for applicants in that Member State, resulting in a risk of inhuman or degrading treatment within the meaning of Article 4 of the Charter of Fundamental Rights of the European Union, the determining Member State shall continue to examine the criteria set out in Chapter III in order to establish whether another Member State can be designated as responsible. Where the transfer cannot be made pursuant to this paragraph to any Member State designated on the basis of the criteria set out in Chapter III or to the first Member State with which the application was lodged, the determining Member State shall become the Member State responsible. 3. Any Member State shall retain the right to send an applicant to a safe third country, subject to the rules and safeguards laid down in Directive 2013/32/EU.’
22.

Even though the provisions at issue in the present case are broadly similar to those of that convention, which does not exclude any class of action for marriage annulment from its scope, the national court refers to paragraph 27 of the explanatory report on the convention of Professor Borrás, approved by the Council on 28 May 1998, ( 6 ) according to which ‘it was necessary to establish grounds of jurisdiction in matrimonial proceedings without becoming involved in any examination of the situation in which the validity of a marriage needs to be considered as part of annulment proceedings when one of the spouses is deceased or after the decease of both spouses, since that situation is not within the scope of the Convention. Such situations arise, in the majority of cases, as preliminary questions relating to successions. Instead, it will be resolved by the international instruments applicable in the matter … or according to the internal legislation of the State where that is possible’. ( 7 )
15.

In those circumstances, the Bundesfinanzgericht decided to stay the proceedings and refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Do three associations of persons constitute three independent traders (taxable persons) where those associations consist of different members of one family, conduct themselves outwardly as such independently in relation to their suppliers and to public authorities, possess their own production facilities, with the exception of two business assets, but market under a common trade mark the greater part of their products through a limited company whose shares are held by the members of the associations of persons and other members of the family? (2) If the three associations of persons are not to be regarded as three independent traders (taxable persons), is any of the following to be regarded as an independent trader (taxable person): (a) the marketing company, or (b) an association of persons consisting of the members of the three associations of persons, which does not conduct itself as such on the market in relation either to suppliers or to customers, or (c) an association of persons consisting of the three associations of persons and the limited company, which does not conduct itself as such on the market in relation either to suppliers or to customers? (3) If the three associations of persons are not to be regarded as three independent traders (taxable persons), is the refusal of the status of a trader (taxable person) (a) retrospective, (b) only for the future, or (c) not permissible at all if the associations of persons were at first, after investigations by the tax authorities, recognised by the Tax Office as independent traders (taxable persons)? (4) If the three associations of persons are to be regarded as three independent traders (taxable persons), are they, as wine growers and therefore farmers, flat-rate farmers if each of those associations of persons which cooperate in practice is in itself covered by the flat-rate scheme for farmers, but the limited company, an association of persons formed of the members of the three associations of persons or an association of persons formed of the limited company and the members of the three associations of persons is, under national law, not covered by the flat-rate scheme on account of the size of the business or its legal form? (5) If the flat-rate scheme for farmers is in principle excluded for the three associations of persons, is that exclusion (a) retrospective, (b) only for the future, or (c) not effective at all?’
24.

However, in the letter accompanying its declaration, and as it explained at the hearing, the Kingdom of the Netherlands stated that, in the course of the negotiations on the draft Framework Decision, it had consistently argued that it should be possible to apply the Framework Decision only to future cases. That Member State explains that the option provided for in Article 28(2) of the Framework Decision was included, inter alia, at its request and that, from its point of view, that option was an important element in the political agreement on that framework decision reached at the JHA Council on 4 December 2006 and 15 February 2007. The Kingdom of the Netherlands also stated that the Framework Decision was placed on the agenda as an ‘A’ item so shortly before the JHA Council meeting of 27 November 2008 that it was not possible to follow the internal procedure for preparing the Council in that connection. Consequently, when that framework decision was adopted at the JHA Council meeting on 27 November 2008, the Kingdom of the Netherlands did not submit a declaration within the meaning of Article 28(2). That Member State states, however, that when political agreement was reached at the JHA Council on 4 December 2006, it announced that it would make the relevant declaration. In its view, that declaration may be considered to have taken effect when the Framework Decision was adopted on 27 November 2008.
6.

Article 6 of Directive 2010/40, headed ‘Specifications’, states: ‘1. The Commission shall first adopt the specifications necessary to ensure the compatibility, interoperability and continuity for the deployment and operational use of ITS for the priority actions. 2. The Commission shall aim at adopting specifications for one or more of the priority actions by 27 February 2013. At the latest 12 months after the adoption of the necessary specifications for a priority action, the Commission shall, where appropriate, after conducting an impact assessment including a cost-benefit analysis, present a proposal to the European Parliament and the Council in accordance with Article 294 of the TFEU on the deployment of that priority action. 3. Once the necessary specifications for the priority actions have been adopted, the Commission shall adopt specifications ensuring compatibility, interoperability and continuity for the deployment and operational use of ITS for other actions in the priority areas. 4. Where relevant, and depending on the area covered by the specification, the specification shall include one or more of the following types of provisions: (a) functional provisions that describe the roles of the various stakeholders and the information flow between them; (b) technical provisions that provide for the technical means to fulfil the functional provisions; (c) organisational provisions that describe the procedural obligations of the various stakeholders; (d) service provisions that describe the various levels of services and their content for ITS applications and services. 5. Without prejudice to the procedures under Directive 98/34/EC the specifications shall, where appropriate, stipulate the conditions in which Member States may, after notification to the Commission, establish additional rules for the provision of ITS services on all or part of their territory, provided that those rules do not hinder interoperability. 6. The specifications shall, where appropriate, be based on any standards referred to in Article 8. The specifications shall, as appropriate, provide for conformity assessment in accordance with Decision No 768/2008/EC. The specifications shall comply with the principles set out in Annex II. 7. The Commission shall conduct an impact assessment including a cost-benefit analysis prior to the adoption of the specifications.’
41.

Third, the argument put forward by the Lithuanian Government would mean that Lithuanian law essentially does not generally set the rate of interest due to taxable persons for a delay in the refunding of tax. However, in situations where that refund has been made pursuant to EU law, this would be contrary to the case-law cited above ( 14 ) and the principle of effectiveness. The right to a refund of tax together with default interest does not mean merely the right to expect to receive interest in the amount which a court wishes to set in the course of proceedings, but the right to receive interest in an amount known in advance, laid down a priori in law. However, the Lithuanian Government appears to overestimate the scope of the freedom that the Member States enjoy when laying down the rules on refunding overpaid VAT. Whilst the first paragraph of Article 183 of Directive 2006/112 provides that the Member States are to determine the conditions under which they are to refund overpaid VAT, the manner in which those conditions are determined must satisfy the minimum criteria of predictability and legal certainty. The same is true as regards determining the amount of interest to which the taxable person is entitled in the event of a delay in the refunding of tax, since the right to receive interest in the event of delay is an element of the right to a refund of overpaid tax. Therefore, the refund conditions, including the amount of interest, cannot be laid down, as the Lithuanian Government would like, on an ad hoc basis by judicial decisions in individual cases concerning specific taxable persons. In my view, such a mechanism would be contrary to the principle of effectiveness, since an essential element of the effective assertion of the rights arising under EU law is certainty as to the scope of those rights and the protection of legitimate expectations in that regard.
7.

Article 24 of the Waste Shipment Regulation provides for take-back when a shipment is illegal and states: ‘1. Where a competent authority discovers a shipment that it considers to be an illegal shipment, it shall immediately inform the other competent authorities concerned. 2. If an illegal shipment is the responsibility of the notifier, the competent authority of dispatch shall ensure that the waste in question is: (a) taken back by the notifier de facto; or, if no notification has been submitted; (b) taken back by the notifier de jure; or, if impracticable; (c) taken back by the competent authority of dispatch itself or by a natural or legal person on its behalf; … … This take-back, recovery or disposal shall take place within 30 days, or such other period as may be agreed between the competent authorities concerned after the competent authority of dispatch becomes aware of or has been advised in writing by the competent authority of destination or transit of the illegal shipment and informed of the reason(s) therefor. … No competent authority shall oppose or object to the return of waste of an illegal shipment. … … 7. Where the waste of an illegal shipment is discovered within a Member State, the competent authority with jurisdiction over the area where the waste was discovered shall be responsible for ensuring that arrangements are made for the safe storage of the waste pending its return or non-interim recovery or disposal in an alternative way.’
8.

Article 75 of Regulation No 4/2009, entitled ‘Transitional provisions’, provides that: ‘1. This Regulation shall apply only to proceedings instituted, to court settlements approved or concluded, and to authentic instruments established as from its date of application, subject to paragraphs 2 and 3. 2. Sections 2 and 3 of Chapter IV shall apply: (a) to decisions given in the Member States before the date of application of this Regulation for which recognition and the declaration of enforceability are requested as from that date; (b) to decisions given as from the date of application of this Regulation following proceedings begun before that date, in so far as those decisions fall with the scope of [Regulation No 44/2001] for the purposes of recognition and enforcement. [Regulation No 44/2001] shall continue to apply to procedures for recognition and enforcement under way on the date of application of this Regulation. The first and second subparagraphs shall apply mutatis mutandis to court settlements approved or concluded and to authentic instruments established in the Member States. 3. Chapter VII on cooperation between Central Authorities shall apply to requests and applications received by the Central Authority as from the date of application of this Regulation.’