LEK Farmacevtska Družba d.d. v Republika Slovenija.
Date: 2016-12-15
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In that regard, 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 (see, to that effect, the judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 76).
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Next, 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 (see, to that effect, judgment of 3 October 2013, Laboratoires Lyocentre, C‑109/12, EU:C:2013:626, paragraph 48).
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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 (see, to that effect, judgment of 12 March 1998, Laboratoires Sarget, C‑270/96, EU:C:1998:103, paragraph 24).
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Directive 2001/83 pursues different objectives from those pursued by the CN. In order to maintain the coherence between the interpretation of the CN and that of the HS, which is established by an international convention to which the European Union is a contracting party, the fact that a product has a marketing authorisation as a medicinal product within the meaning of Directive 2001/83 cannot be decisive as regards assessing whether that product falls within the category of ‘medicaments’ within the meaning of CN heading 3004 (see, to that effect, judgments of 12 March 1998, Laboratoires Sarget, C‑270/96, EU:C:1998:103, paragraph 25, and of 4 March 2015, Oliver Medical, C‑547/13, EU:C:2015:139, paragraph 53).
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First, it is settled case-law that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods for customs purposes is in general to be sought in their objective characteristics and properties as defined in the wording of the relevant heading of the CN and in the section or chapter notes (see judgment of 17 February 2016, Salutas Pharma, C‑124/15, EU:C:2016:87, paragraph 29 and the case-law cited).
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Thus, the chapter notes to the CN constitute important means for ensuring the uniform application of the common customs tariff and provide, as such, useful information for its interpretation. The content of those notes must therefore be consistent with the provisions of the CN and cannot modify its scope (see judgment of 17 February 2016, Salutas Pharma, C‑124/15, EU:C:2016:87, paragraph 30 and the case-law cited).
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Furthermore, the explanatory notes drawn up by the Commission as regards the CN and by the WCO as regards the HS are an important aid to the interpretation of the scope of the various tariff headings but do not have legally binding force (see judgment of 17 February 2016, Salutas Pharma, C‑124/15, EU:C:2016:87, paragraph 31 and the case-law cited).
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In order to classify goods in Chapter 30 of the CN, it is necessary to examine whether the latter had 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 (see, to that effect, judgment of 30 April 2014, Nutricia, C‑267/13, EU:C:2014:277, paragraph 20 and the case-law cited).
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In that regard, it must be recalled that CN heading 2106 includes ‘Food preparations not elsewhere specified or included’ and also covers preparations often referred to as ‘food supplements’, presented in packages indicating they maintain general health or well-being (see, to that effect, judgment of 17 December 2009, Swiss Caps, C‑410/08 to C‑412/08, EU:C:2009:794, paragraph 31).
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In addition, it is settled case law that a classification regulation is of general application in so far as it does not apply to an individual trader but, in general, to products which are the same as that examined by the Customs Code Committee. In the interpretation of a classification regulation, in order to determine its scope, account must be taken, inter alia, of its statement of reasons (see judgment of 4 March 2015, Oliver Medical, C‑547/13, EU:C:2015:139, paragraph 55 and the case-law cited).
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Nevertheless, the application by analogy of a classification regulation, such as Regulation No 1264/98 and Implementing Regulation No 727/2012, to products similar to those covered by that regulation facilitates a coherent interpretation of the CN and the equal treatment of traders (see, to that effect, judgment of 4 March 2015, Oliver Medical, C‑547/13, EU:C:2015:139, paragraph 57, and the case law cited).