ddrg/super_eurlex huggingface dataset:
Heading 3004 of the Combined Nomenclature of the Common Customs Tariff set out in Annex I to Regulation No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Regulation No 1006/2011, must be interpreted as meaning that goods which fall within the definition of ‘medicinal product’, within the meaning of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2011/62, are not automatically required to be classified under that heading.

It is clear, first of all, from recitals 2 to 5 of Directive 2001/83 that that directive aims to ensure the approximation of national legislation concerning medicinal products whilst ensuring the attainment of its essential aim, which is the safeguarding of public health.

The classification of a product in one Member State as a medicinal product within the meaning of Directive 2001/83, does not require the competent authorities of another Member State to classify the same product as a medicinal product within the meaning of other instruments of EU law.

Furthermore, it is clear from the eighth recital of Regulation No 2685/87 that the provisions of the CN must be given an identical interpretation by each of the Member States.

Moreover, it follows from the wording of Article 1 of Directive 2001/83 that a medicinal product within the meaning of that directive includes, first, any substance or combination of substances presented for treating or preventing disease in human beings and, second, any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings.

Therefore, that definition does not require that products falling within it necessarily comply with the condition for classification in Chapter 30 of the CN, namely that they have clearly defined therapeutic or prophylactic characteristics with an effect concentrated on precise functions of the human organism or are capable of being applied in the prevention or treatment of diseases or ailments.

Directive 2001/83 pursues different objectives from those pursued by the CN.

(see paras 31-37, operative part 1)
Case C‑316/15

Timothy Martin Hemming and Others

v

Westminster City Council

(Request for a preliminary ruling

from the Supreme Court of the United Kingdom)

(Reference for a preliminary ruling — Freedom to provide services — Directive 2006/123/EC — Article 13(2) — Authorisation procedures — Concept of charges which may be incurred)

Summary — Judgment of the Court (Third Chamber), 16 November 2016

Freedom of establishment — Freedom to provide services — Services in the internal market — Directive 2006/123 — Authorisation scheme — Requirement to pay a fee — Part of the fee corresponding to the costs relating to the management and enforcement of the authorisation scheme concerned — Not permissible — Part refundable if the application for authorisation is refused — No bearing

(European Parliament and Council Directive 2006/123, Art. 13(2))

Article 13(2) of Directive 2006/123 on services in the internal market must be interpreted as precluding the requirement for the payment of a fee, at the time of submitting an application for the grant or renewal of authorisation, part of which corresponds to the costs relating to the management and enforcement of the authorisation scheme concerned, even if that part is refundable if that application is refused.

Whether the fee payable by an applicant is refundable when his licence application is rejected has no bearing on ascertaining whether there is a charge within the meaning of Article 13(2) of that directive. The fact that a fee must be paid constitutes a financial obligation, and therefore a charge, which the applicant must pay in order for his application to be considered, notwithstanding the fact that the amount may subsequently be refunded if that application is rejected.

In order to comply with Article 13(2) of Directive 2006/123, the charges referred to must, in the words of that provision, be reasonable and proportionate to the cost of the authorisation procedures and not exceed the cost of those procedures. In calculating the amount of duties paid by way of fees or dues, the Member States are entitled to take account, not only of the material and salary costs which are directly related to the effecting of the transactions in respect of which they are incurred, but also of the proportion of the overheads of the competent authority which can be attributed to those transactions.

The costs taken into account may not include the expenditure linked to the authority in question’s general supervisory activities, given that, first, Article 13(2) of Directive 2006/123 is directed only at the cost of the procedures and, secondly, pursues the aim of facilitating access to service activities. That aim would not be served by a requirement to prefinance the costs of the management and enforcement of the authorisation scheme concerned, including, inter alia, the costs of detecting and prosecuting unauthorised activities.

(see paras 28, 29, 31-34, operative part)
Article 5(3) of Regulation No 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters must be interpreted as meaning that, in a situation in which a harmful event occurred because a mistake was made in a share purchase contract in the course of drafting it which resulted in the purchase price of the shares concerned multiplying, the place where the harmful event occurred may not be construed as being, failing any other connecting factors, the place in a Member State where the damage occurred, when that damage consists exclusively of financial damage which materialises directly in the applicant’s bank account and is the direct result of an unlawful act committed in another Member State.

Consequently, purely financial damage which occurs directly in the applicant’s bank account cannot, in itself, be qualified as a relevant connecting factor, pursuant to Article 5(3) of Regulation No 44/2001. It is only where the other circumstances specific to the case also contribute to attributing jurisdiction to the courts for the place where a purely financial damage occurred, that such damage could, justifiably, entitle the applicant to bring the proceedings before the courts for that place.

(see paras 38-40, operative part 1)
Article 119 of the EC Treaty (subsequently Article 141 EC), Article 1 of Directive 75/117 on the approximation of the laws of the Member States relating to the application of the principle of equal pay for men and women, and Articles 11(2)(b) and 11(3) of Directive 92/85 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding, must be interpreted, in a situation where the Member State concerned did not provide for the maintenance of all the elements of pay to which an ordinary magistrate was entitled before her maternity leave, as not precluding a national law under which, in the case of a period of compulsory maternity leave taken prior to 1 January 2005, an ordinary magistrate is not entitled to receive an allowance in respect of costs that ordinary magistrates incur in the performance of their professional functions, provided that that worker received, during that period, an income in an amount at least equivalent to that of the benefit provided for under national social security legislation which she would have received in the event of a break in her activities on grounds connected with her state of health, which is a matter for the national court to determine.

The concept of pay used in Article 11 of Directive 92/85, like the definition in Article 119 of the EC Treaty (subsequently Article 141 EC), encompasses the consideration paid directly or indirectly by the employer during the worker’s maternity leave in respect of her employment. By contrast, the concept of allowance to which that provision also refers includes all income received by the worker during her maternity leave which is not paid to her by her employer pursuant to the employment relationship.

It is thus necessary to distinguish the concepts of ‘payment’ referred to in Article 11(2) and (3) of Directive 92/85 from the concept of ‘full pay’ received when the person is actually working and which, in the present case, includes the special judicial allowance related to expenses that ordinary magistrates incur in the performance of their professional functions.

In that regard, the legislature of the European Union wished to ensure that, during her maternity leave, the worker should receive an income of an amount at least equivalent to that of the allowance provided for by national social security legislation in the event of a break in her activities on health grounds.

When a worker is absent from work because she is on maternity leave, the minimum protection required by Article 11(2) and (3) of Directive 92/85 does not therefore require that the person concerned should continue to receive full pay.

Furthermore, the mere fact that an ordinary magistrate was not entitled to the special judicial allowance during a period of compulsory maternity leave, unlike her male colleagues who were working, does not constitute discrimination on the grounds of sex within the meaning of Article 119 of the EC Treaty (subsequently Article 141 EC) and Article 1 of Directive 75/117.

(see paras 30, 32-34, 41, 44, operative part)
The Combined Nomenclature set out in Annex I to Regulation No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Implementing Regulation No 927/2012, must be interpreted as meaning that an anti-radiation protective apron-coat, consisting of man-made fibres and designed to be worn solely or mainly in order to provide protection to persons exposed to radiation during their professional activities, must be classified in subheading 6211 33 10 00 0 of that nomenclature, due to its objective characteristics and properties, including, in particular, its external appearance, without it being necessary to refer to the components conferring on the product in question its essential character.

The fact that those goods contain an internal layer consisting principally of antimony, which gives them their anti-radiation protection character, does not suffice for them to be classified as an antimony article, covered by heading 8110 of the combined nomenclature.

(see paras 26, 32, 34, operative part)
1.

Institutions of the European Union — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of the purpose of inspections, investigations and audits — Scope — Application to administrative files relating to procedures for reviewing State aid — General presumption that the exception applies to the right of access to all the documents on the administrative file — Request concerning only certain documents in the file — No effect (European Parliament and Council Regulation No 1049/2001, Art. 4(2), third indent) (see paras 36, 37, 41, 54)
Article 23(3) of Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States, as amended by Council Framework Decision 2009/299/JHA of 26 February 2009, must be interpreted as meaning that, in a situation such as that at issue in the main proceedings, the executing and issuing judicial authorities agree on a new surrender date under that provision where the surrender of the requested person within 10 days of a first new surrender date agreed on pursuant to that provision proves impossible on account of the repeated resistance of that person, in so far as, on account of exceptional circumstances, that resistance could not have been foreseen by those authorities and the consequences of the resistance for the surrender could not have been avoided in spite of the exercise of all due care by those authorities, which is for the referring court to ascertain.

Articles 15(1) and 23 of Framework Decision 2002/584, as amended by Framework Decision 2009/299, must be interpreted as meaning that those authorities remain obliged to agree on a new surrender date if the time limits prescribed in Article 23 have expired.

(see para. 74, operative part)
The concept of a ‘carrier’ under an obligation to produce goods intact at the customs office of destination in Article 96(2) of Regulation No 2913/92 establishing the Community Customs Code, as amended by Regulation No 648/2005, is to be interpreted as referring to any person, including a transport subcontractor, who actually transports the goods moving under the external Community transit procedure and has agreed to transport the goods knowing that they are moving under that procedure.

Article 96(2) of Regulation No 2913/92, as amended by Regulation No 648/2005, is to be interpreted as meaning that a transport subcontractor who has, first, handed over the goods to the main carrier, together with the transit document, at the car park of the customs office of destination and, second, assumed responsibility for the goods once again in order to continue with the transport, was under an obligation to ensure that the goods were produced at the customs office of destination and may be held liable for any failure to ensure that the goods were thus produced only if he was aware, when he again assumed responsibility for the goods, that the transit procedure had not been properly completed, which is a matter to be determined by the national court.

The liability of the carrier under that provision is based on physical control of the goods. Accordingly, a carrier who transfers that control to another carrier by handing over the goods has, in principle, discharged the obligation laid down in that provision, provided that the second carrier is aware that the goods are moving under Community transit. While the fact that goods brought into the customs territory of the Community are subject to customs supervision, as provided for in Article 37 of the Customs Code, precludes the carrier from freeing himself of his liability under Article 96(2) of the code by handing the goods over to simply any other person, the carrier may nonetheless discharge that liability by handing them over to another person who is, pursuant to Article 96 of that code, under an obligation to produce the goods in a satisfactory manner at the customs office of destination, such as another carrier who accepts the goods knowing that they are moving under Community transit.

(see para. 31, 32, 39, operative part 2)
When it is fixing total allowable catches [TACs] and allocating fishing opportunities among the Member States, the Council has to evaluate a complex economic situation, for which it has broad discretion. In such circumstances, the Council’s discretion is not limited to the nature and scope of the measures to be taken but extends, to some degree, to the finding of the basic facts. In reviewing the exercise of such a power, the Court must confine itself to examining whether there has been a manifest error or misuse of power or whether the authority in question has clearly exceeded the bounds of its discretion.

In that regard, although Article 6(2) of the same regulation establishes an obligation to ‘take account’ of available scientific, technical and economic advice when adopting conservation measures, it does not prevent the EU legislature from adopting such conservation measures where there is no conclusive scientific, technical and economic advice. Fishery conservation measures need not be completely consistent with the scientific advice and the absence of such advice or the fact that it is inconclusive cannot prevent the Council from adopting such measures as it deems necessary for achieving the objectives of the common fisheries policy [CFP]. It follows that the Council had the power, under Regulation No 1367/2014 fixing for 2015 and 2016 the fishing opportunities for Union fishing vessels for certain deep-sea fish stocks, to adopt a common TAC for roundnose grenadier and roughhead grenadier even in the absence of ‘conclusive’ scientific evidence that those two species occur and are caught in the management zones in question, as it considered that that measure was appropriate for the conservation of roundnose grenadier resources.

(see paras 46, 49-51)
Case C‑461/15

E.ON Kraftwerke GmbH

v

Bundesrepublik Deutschland

(Request for a preliminary ruling from the Verwaltungsgericht Berlin)

‛Reference for a preliminary ruling — Environment — Greenhouse gas emission allowance trading scheme within the European Union — Directive 2003/87/EC — Harmonised free allocation of emission allowances — Decision 2011/278/EU — Change to the allocation — Article 24(1) — Obligation of the operator of the installation to provide information — Scope’

Summary — Judgment of the Court (Sixth Chamber), 8 September 2016

Environment — Atmospheric pollution — Directive 2003/87 — Greenhouse gas emission allowance trading scheme — Transitional rules for free allocation of quotas — Obligation of Member States to ensure that operators provide information on changes to their installations — Scope

(European Parliament and Council Directive 2003/87, Art. 10a; Commission Decision 2011/278, Art. 24(1))

Article 24(1) of Decision 2011/278 determining transitional Union-wide rules for harmonised free allocation of emission allowances pursuant to Article 10a of Directive 2003/87 must be interpreted as not precluding a Member State from requiring undertakings which, being subject to the greenhouse gas emission allowance trading obligation within the European Union, receive a free allocation of those allowances to provide information relating to all planned or effective changes to the capacity, activity level and operation of an installation, without limiting that requirement solely to information relating to changes that would affect the allocation.

It may be seen from the provisions of Article 24 of that decision that they aim to take account of changes to the operation of installations, in order for the Member States, in a first stage, to determine the number of emission allowances allocated free of charge to each incumbent installation on their territory and for the Commission, in a second stage, to determine the final total annual amount of emission allowances allocated free of charge.

In that context, Member States should ensure that data collected from the operators and used for allocation purposes is complete, consistent and presents the highest achievable accuracy. It is therefore for the Member States to determine themselves what relevant information for the competent authorities must be collected from the operators.

(see paras 36, 37, 40, operative part)
A Member State fails to fulfil its obligations under Article 4(3) of Directive 2001/80 on the limitation of emissions of certain pollutants into the air from large combustion plants, read in conjunction with Part A of Annex VI thereto, by failing to correctly apply that directive to a power station.

In that regard, even if it was established that the derogation provided for in footnote (3) to Part A of Annex VI to Directive 2001/80 was negotiated to include a plant that operated on solid fuels with a volatile content of less than 10%, that plant must nonetheless meet the criteria set out by that provision in order to qualify for, and to continue to qualify for, that derogation.

Furthermore, a Member State cannot reasonably invoke reasons of safety and of a purely economic nature in order to dispute the failure of which it is accused.

(see paras 50-53, operative part)
Case C‑261/15

Nationale Maatschappij der Belgische Spoorwegen NV

v

Gregory Demey

(Request for a preliminary ruling from the

vredegerecht te Ieper)

‛Rail transport — Regulation (EC) No 1371/2007 — Passengers’ rights and obligations — Absence of a ticket — Failure to regularise within the prescribed period — Criminal offence’

Summary — Judgment of the Court (Tenth Chamber), 21 September 2016

Transport — Rail transport — Regulation No 1371/2007 — Rail passengers’ rights and obligations — Unticketed journey not regularised within the prescribed periods — No contractual relationship between the passenger and the railway undertaking

(European Parliament and Council Regulation No 1371/2007, Annex I, Art. 6(2))

The final sentence of Article 6(2) of Appendix A to the Convention Concerning International Carriage by Rail (COTIF), in Annex I to Regulation No 1371/2007 on rail passengers’ rights and obligations, must be interpreted as not precluding national provisions which lay down that a person making a train journey while not in possession of a ticket for that purpose, who fails to regularise his situation within the periods laid down in those provisions, does not have a contractual relationship with the railway undertaking.

Article 6(2) of Appendix A presupposes the existence of a contract of carriage concluded beforehand and relates only to the proof of the existence of such a contract. It follows that Article 6(2) does not govern the conditions for the formation of a contract of carriage, those conditions being governed by the relevant national provisions.

(see paras 26, 30, 34, 35, operative part)