ddrg/super_eurlex huggingface dataset:
14

Recital 7 in the preamble to that directive states as follows: ‘Particularly as a result of scientific and technical progress, the definitions and scope of [Directive 2001/83] should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products for human use. In order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. This definition should specify the type of action that the medicinal product may exert on physiological functions. This enumeration of actions will also make it possible to cover medicinal products such as gene therapy, radiopharmaceutical products as well as certain medicinal products for topical use. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a medicinal product but could also fall within the definition of other regulated products, it is necessary, in case of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation.’
11

Article 17 of that directive provides: ‘1. Member States shall take the measures necessary to ensure that the commercial agent is, after termination of the agency contract, indemnified in accordance with paragraph 2 or compensated for damage in accordance with paragraph 3. (a) The commercial agent shall be entitled to an indemnity if and to the extent that: — he has brought the principal new customers or has significantly increased the volume of business with existing customers and the principal continues to derive substantial benefits from the business with such customers, and — the payment of this indemnity is equitable having regard to all the circumstances and, in particular, the commission lost by the commercial agent on the business transacted with such customers. Member States may provide for such circumstances also to include the application or otherwise of a restraint of trade clause, within the meaning of Article 20; (b) The amount of the indemnity may not exceed a figure equivalent to an indemnity for one year calculated from the commercial agent’s average annual remuneration over the preceding five years and if the contract goes back less than five years the indemnity shall be calculated on the average for the period in question; (c) The grant of such an indemnity shall not prevent the commercial agent from seeking damages. 3. The commercial agent shall be entitled to compensation for the damage he suffers as a result of the termination of his relations with the principal. Such damage shall be deemed to occur particularly when the termination takes place in circumstances: — depriving the commercial agent of the commission which proper performance of the agency contract would have procured him whilst providing the principal with substantial benefits linked to the commercial agent’s activities, — and/or which have not enabled the commercial agent to amortise the costs and expenses that he had incurred for the performance of the agency contract on the principal’s advice. ... 5. The commercial agent shall lose his entitlement to the indemnity in the instances provided for in paragraph 2 or to compensation for damage in the instances provided for in paragraph 3, if within one year following termination of the contract he has not notified the principal that he intends pursuing his entitlement. …’
3

Article 9 of the Convention of 25 June 1998 on access to information, public participation in decision-making and access to justice in environmental matters, approved on behalf of the European Community by Council Decision 2005/370/EC of 17 February 2005 (OJ 2005 L 124, p. 1) (‘the Århus Convention’), provides: ‘… 2. Each Party shall, within the framework of its national legislation, ensure that members of the public concerned (a) [h]aving a sufficient interest or, alternatively, (b) [m]aintaining impairment of a right, where the administrative procedural law of a Party requires this as a precondition, have access to a review procedure before a court of law and/or another independent and impartial body established by law, to challenge the substantive and procedural legality of any decision, act or omission subject to the provisions of [A]rticle 6 and, where so provided for under national law and without prejudice to paragraph 3 below, of other relevant provisions of this Convention. What constitutes a sufficient interest and impairment of a right shall be determined in accordance with the requirements of national law and consistently with the objective of giving the public concerned wide access to justice within the scope of this Convention. To this end, the interest of any non-governmental organisation meeting the requirements referred to in [Article 2(5)] shall be deemed sufficient for the purpose of subparagraph (a) above. Such organisations shall also be deemed to have rights capable of being impaired for the purpose of subparagraph (b) above. The provisions of this paragraph 2 shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law. 3. In addition and without prejudice to the review procedures referred to in paragraphs 1 and 2 above, each Party shall ensure that, where they meet the criteria, if any, laid down in its national law, members of the public have access to administrative or judicial procedures to challenge acts and omissions by private persons and public authorities which contravene provisions of its national law relating to the environment. …’
19

The General Court also rejected the five remaining pleas, put forward in the alternative, seeking a reduction in the amount of the fine. As regards in particular the first part of the fourth plea, alleging that the Commission took into account, for the purposes of calculating the fine, the actual impact of the infringement on the market, whereas that impact was not capable of being measured, the General Court held, in paragraph 117 of the judgment under appeal that ‘as is apparent from the wording of the [1998] Guidelines, the actual impact of the infringement on the market falls to be taken into account for the purposes of assessing the gravity of the infringement only when it is capable of being measured’. In paragraph 118 of that judgment, the Court rejected, on that ground, the appellant’s argument that it had to reduce the amount of the fine imposed by the Commission when the impact of the infringement on the market is not capable of being measured. In that context, it sought to distinguish the present case from Case T-279/02 Degussa v Commission [2006] ECR II-897, relied on by the appellant. To that end, the General Court found, in paragraph 119 of the judgment under appeal, that, ‘[i]n the present case, the Commission does not claim to be able to measure the impact of the infringement on the market nor has the [appellant] put forward any argument or presented any material that would tend to show that the cartel had not, in fact, had any effect and that, as a result, it had not had any impact on the market’.
36

The CN does not define ‘parts’ within the meaning of CN heading 7321. None the less, it is clear from the Court’s case-law, developed in the context of Chapters 84 and 85 of Section XVI and of Chapter 90 of Section XVIII of the CN, that the notion of ‘parts’ implies a whole for the operation of which the part is essential (see, inter alia, Case C-183/06 RUMA [2007] ECR I-1559, paragraph 31; Case C-152/10 Unomedical [2011] ECR I-5433, paragraph 29; and Rohm & Haas Electronic Materials CMP Europe and Others, paragraph 34). It follows from that case-law that, in order to classify an article as ‘parts’ within the meaning of those chapters, it is not sufficient to show that, without that article, the machine or apparatus is not able to carry out its intended functions. It must be established that the mechanical or electric functioning of the machine or apparatus in question is dependent on that article (see, to that effect, Case C-276/00 Turbon International [2002] ECR I-1389, paragraph 30, and Rohm & Haas Electronic Materials CMP Europe and Others, paragraph 35). Furthermore, account should be taken of note 2(a) to Section XV of the CN, which specifies that references to ‘parts of goods’, inter alia in CN heading 7321, do not include references to ‘parts of general use’.
6

Article 26 of the Sixth Directive, entitled ‘Special scheme for travel agents’, provides: ‘1. Member States shall apply [VAT] to the operations of travel agents in accordance with the provisions of this Article, where the travel agents deal with customers in their own name and use the supplies and services of other taxable persons in the provision of travel facilities. This Article shall not apply to travel agents who are acting only as intermediaries and accounting for tax in accordance with Article 11A(3)(c). In this Article travel agents include tour operators. 2. All transactions performed by the travel agent in respect of a journey shall be treated as a single service supplied by the travel agent to the traveller. It shall be taxable in the Member State in which the travel agent has established his business or has a fixed establishment from which the travel agent has provided the services. The taxable amount and the price exclusive of tax, within the meaning of Article 22(3)(b), in respect of this service shall be the travel agent’s margin, that is to say, the difference between the total amount to be paid by the traveller, exclusive of [VAT], and the actual cost to the travel agent of supplies and services provided by other taxable persons where these transactions are for the direct benefit of the traveller. 3. If transactions entrusted by the travel agent to other taxable persons are performed by such persons outside the Community, the travel agent’s service shall be treated as an exempted intermediary activity under Article 15(14). Where these transactions are performed both inside and outside the Community, only that part of the travel agent’s service relating to transactions outside the Community may be exempted. 4. [VAT] charged to the travel agent by other taxable persons on the transactions described in paragraph 2 which are for the direct benefit of the traveller shall not be eligible for deduction or refund in any Member State.’
18

In those circumstances, the Gerechtshof te ’s-Gravenhage decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling: ‘1. Is Article 7(1) of Directive [96/9] to be interpreted as meaning that the whole or a qualitatively or quantitatively substantial part of the contents of a database offered on a website (on line) is re-utilised (made available) by a third party if that third party makes it possible for the public to search the whole contents of the database or a substantial part thereof in real time with the aid of a dedicated meta search engine provided by that third party, by means of a query entered by a user in “translated” form into the search engine of the website on which the database is offered? 2. If not, is the situation different if, after receiving the results of the query, the third party sends to or displays for each user a very small part of the contents of the database in the format of his own website? 3. Is it relevant to the answers to Questions 1 and 2 that the third party undertakes those activities continuously and, with the aid of its search engine, responds daily to a total of 100000 queries received from users in “translated” form and makes available the results thereof to various users in a manner such as that described above? 4. Is Article 7(5) of Directive [96/9] to be interpreted as meaning that the repeated and systematic re-utilisation of insubstantial parts of the contents of the database which conflicts with normal exploitation or unreasonably harms the legitimate interests of the database maker is not permissible, or is it sufficient for there to be repeated or systematic re-utilisation? 5. If repeated and systematic re-utilisation is a requirement, (a) what does “systematic” mean? (b) is re-utilisation systematic when an automated system is used? (c) is it relevant that a dedicated meta search engine is used in the manner described above? 6. Is Article 7(5) of Directive [96/9] to be interpreted as meaning that the prohibition laid down thereunder does not apply if a third party repeatedly makes available to individual users of a meta search engine belonging to that third party only insubstantial parts of the contents of the database in response to each query? 7. If so, does that also apply if the cumulative effect of the repeated re-utilisation of those insubstantial parts is that a substantial part of the contents of the database is made available to the individual users together? 8. Is Article 7(5) of Directive [96/9] to be interpreted as meaning that, if conduct which has not been approved and which is such that, as a result of the cumulative effect of re-utilisation, the whole or a substantial part of the contents of a protected database is made available to the public, the requirements of that provision are satisfied, or must it also be claimed and proved that those acts conflict with the normal exploitation of the database or unreasonably harm the legitimate interests of the database maker? 9. Is it assumed that the investment of the database maker is seriously harmed in the event of the aforementioned conduct?’
23

In those circumstances, the Bundesgerichtshof decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘1. Is Article 11(2) of Regulation … No 6/2002 to be interpreted as meaning that, in the normal course of business, a design could reasonably have become known to the circles specialised in the sector concerned, operating within the European Union, if images of the design were distributed to traders? 2. Is the first sentence of Article 7(1) of Regulation … No 6/2002 to be interpreted as meaning that a design could not reasonably have become known in the normal course of business to the circles specialised in the sector concerned, operating within the European Union, even though it was disclosed to third parties without any explicit or implicit conditions of confidentiality, if: (a) it is made available to only one undertaking in the specialised circles, or (b) it is exhibited in a showroom of an undertaking in China which lies outside the scope of normal market analysis? 3(a) Is Article 19(2) of Regulation … No 6/2002 to be interpreted as meaning that the holder of an unregistered Community design bears the burden of proving that the contested use results from copying the protected design? 3(b) If Question 3(a) is answered in the affirmative: Is the burden of proof reversed or is the burden of proof incumbent on the holder of the unregistered Community design lightened if there are material similarities between the design and the contested use? 4(a) Is the right to obtain an injunction prohibiting further infringement of an unregistered Community design, provided for in Article 19(2) and Article 89(1)(a) of Regulation … No 6/2002, extinguished over time? 4(b) If Question 4(a) is answered in the affirmative: Is such extinction governed by European Union law and, if so, by what provision? 5(a) Is the right to bring an action seeking an injunction prohibiting further infringement of an unregistered Community design, provided for in Article 19(2) and Article 89(1)(a) of Regulation … No 6/2002, subject to time-barring? 5(b) If Question 5(a) is answered in the affirmative: Is such time-barring governed by European Union law and, if so, by what provision? 6. Is Article 89(1)(d) of Regulation … No 6/2002 to be interpreted as meaning that claims for destruction, disclosure of information and damages by reason of infringement of an unregistered Community design which are pursued in relation to the entirety of the European Union are subject to the law of the Member States in which the acts of infringement are committed?’
7

Article 80 of Regulation No 528/2012, entitled ‘Fees and charges’, provides: ‘1. The Commission shall adopt, on the basis of the principles set out in paragraph 3, an implementing Regulation specifying: (a) the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII; (b) the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and (c) conditions of payment. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). It shall apply only with respect to fees paid to the Agency. The Agency may collect charges for other services it provides. The fees payable to the Agency shall be set at such a level as to ensure that the revenue derived from the fees, when combined with other sources of the Agency’s revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered. The fees payable shall be published by the Agency. 2. Member States shall directly charge applicants fees for services that they provide with respect to the procedures under this Regulation, including the services undertaken by Member States’ competent authorities when acting as evaluating competent authority. Based on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees. Member States may levy annual fees with respect to biocidal products made available on their markets. Member States may collect charges for other services they provide. Member States shall set and publish the amount of fees payable to their competent authorities. 3. Both the implementing Regulation referred to in paragraph 1 and Member States’ own rules concerning fees shall respect the following principles: (a) fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs; (b) partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time-limit; (c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases; (d) the structure and amount of fees shall take into account whether information has been submitted jointly or separately; (e) in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and (f) the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.’
16

Article 9 of that regulation is in Chapter III thereof and is entitled ‘Conditions governing action by the Customs Authorities and by the authority competent to decide on the case’. It is worded as follows: ‘1. Where a customs office to which the decision granting an application by the right-holder has been forwarded pursuant to Article 8 is satisfied, after consulting the applicant where necessary, that goods in one of the situations referred to in Article 1(1) are suspected of infringing an intellectual property right covered by that decision, it shall suspend release of the goods or detain them. … 2. The competent customs department or customs office referred to in paragraph 1 shall inform the right-holder and the declarant or holder of the goods … of its action and is authorised to inform them of the actual or estimated quantity and the actual or supposed nature of the goods whose release has been suspended or which have been detained, without being bound by the communication of that information to notify the authority competent to take a substantive decision. 3. With a view to establishing whether an intellectual property right has been infringed under national law, … the customs office or department which processed the application shall inform the right-holder, at his request and if known, of the names and addresses of the consignee, the consignor, the declarant or the holder of the goods and the origin and provenance of goods suspected of infringing an intellectual property right. …’
17

Article 299 of the Social Security Code provides as follows: ‘(1) An allowance for bringing up a family shall be granted, on the applicant’s request, to any person: (a) who is officially resident within the meaning of Article 269 in the Grand Duchy of Luxembourg and actually lives there or who is insured on a compulsory basis under the Luxembourg social security scheme by reason of an occupational activity and to whom Community regulations are applicable; (b) who is bringing up in his or her home one or more children in respect of whom family allowances are paid to the applicant or to his or her spouse, from whom the applicant is not permanently separated, or his or her partner … and who satisfy with regard to the applicant the requirements laid down in Article 270 [of the Code, relating to the determination of the family unit]; (c) whose principal activity is bringing up the child or children in the family home and who is not employed or does not receive any equivalent income. (2) By way of derogation from the requirement laid down in paragraph (1)(c), the allowance may also be claimed by any person who is engaged in one or more occupational activities or who receives equivalent income and who, irrespective of the number of hours worked, has income, together with his or her spouse, from whom he or she is not permanently separated, or the person with whom he or she is cohabiting, which, after allowing for deductions for social security contributions, is not more than: (a) three times the minimum wage if that person is bringing up one child; (b) four times the minimum wage if that person is bringing up two children; (c) five times the minimum wage if that person is bringing up three or more children. (3) By way of derogation from the requirements laid down in paragraph 1(c) and paragraph 2, half the allowance for bringing up a family may be claimed by any person who, irrespective of his or her income: (a) is engaged in one or more occupational activities on a part-time basis, where the total number of hours actually worked per week is not greater than half the normal weekly working hours applicable to that person under statute or by virtue of a collective labour agreement, or has equivalent income corresponding to the working hours determined above; (b) is primarily engaged in bringing up the child or children in the family home for a period at least equivalent to half the normal weekly working hours, as determined under subparagraph (a). …’