Keywords
Summary

Keywords

Common Customs Tariff – Importation free of customs duties – Medicinal products

(Council Regulation No 2658/87, Annex I, Part One, Section II, C, point 1(i), and Part Three, Annex 3, as amended by Commission Regulations No 2031/2001 and No 1832/2002)

Summary

Part One, Section II, C, 1(i) of Annex I to Regulation No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Regulations Nos 2031/2001 and 1832/2002, must be interpreted as meaning that a pharmaceutical substance listed in Annex 3 of Part Three of Annex I, to which other substances have been added, in particular pharmaceutical substances, no longer qualifies for the duty-free treatment which would have applied if such a substance had been in its pure form.

The provision governing the application of duty-free treatment constitutes a derogation from the principle that goods imported into the European Union are, as a general rule, subject to customs duties and, as such, must therefore be interpreted strictly. Consequently, in the absence of an express indication or another factor supporting the conclusion that the legislature of the European Union intended to grant duty-free treatment to the pharmaceutical substances listed in Annex 3 which, subject to possible residual impurities contained in those substances, are not in their pure form, Regulation No 2658/87 cannot be interpreted as meaning that pharmaceutical substances to which other substances have been added qualify for that relief.

In addition, that interpretation is the most appropriate for ensuring a uniform application of the provisions of Regulation No 2658/87 in so far as it leaves only limited discretion to the national customs authorities to determine whether a pharmaceutical substance is in its pure form or not.

(see paras 16-17, 25-26, operative part)