Asunto C-514/04: Sentencia del Tribunal de Justicia (Sala Segunda) de 13 de julio de 2006 (petición de decisión prejudicial planteada por el Gerechtshof te Amsterdam — Países Bajos) — Uroplasty BV/Inspecteur van de Belastingdienst-Douanedistrict Rotterdam (Clasificación arancelaria — Copos estériles de dimetilpolisiloxano — Elastómero de silicona — Concepto de forma primaria — Medicamento — Envase — Concepto de aparato que se implanta en el organismo)

• Jurisdiction: European Union
• Published date: 21 September 2006
• Celex Number: C2006/224/13

16.9.2006 EN Official Journal of the European Union C 224/8

---

Judgment of the Court (Second Chamber) of 13 July 2006 (reference for a preliminary ruling from the Gerechtshof te Amsterdam — Netherlands) — Uroplasty BV v Inspecteur van de Belastingdienst — Douanedistrict Rotterdam

(Case C-514/04) (1)

(Tariff classification - Sterile flakes of polydimethilsiloxane - Silicone elastomer - Meaning of ‘primary form’ - Medicament - Packaging - Meaning of ‘appliance implanted in the body’)

(2006/C 224/13)

Language of the case: Dutch

Referring court

Gerechtshof te Amsterdam

Parties to the main proceedings

Applicant: Uroplasty BV

Defendant: Inspecteur van de Belastingdienst — Douanedistrict Rotterdam

Re:

Preliminary ruling — Gerechtshof te Amsterdam — Tariff classification of the product Macroplastic implant — Injectable sterile suspension of solid particles of silicone elastomer for the treatment of vesicoureteral (or vesicorenal) reflux

Operative part of the judgment

Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Commission Regulation (EC) No 2388/2000 of 13 October 2000, is to be interpreted as meaning that a product, such as the polydimethilsiloxane, made up of sterile flakes, specially developed and intended only to be implanted in the body for the treatment of a condition and which is packaged at the time of its presentation to customs in 1 kg bags, is to be regarded as an appliance to be implanted in the body which must be classified under heading 9021 of the Combined Nomenclature. Since the purpose of such a product is not to replace an organ but to enable a...