Opinion of the Advocate General — ECLI:EU:C:1997:389
Date: 1997-07-17
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Free movement of goods;Common customs tariff;Customs Union;Sugar
Procedure: Reference for a preliminary ruling
Origin: France

Summary of the Judgmen t 
Common Customs Tariff— Tariff headings — Product having no specific therapeutic or prophy-
lactic characteristics — Classification as a 'medicament' under heading 3004 of the Combined 
Nomenclature — Excluded — Product regarded as a 'medicinal product' for the purposes of 
Directive 65/65 — Not the deciding factor as regards tariff chssification 
(Council Regulation No 1010/86; Council Directive 65/65) 
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SUMMARY — CASE C-270/96 
A product presented in the form of chewable 
tablets, effervescent tablets, and a drinkable 
solution in ampoules, their active ingredients 
being in principle identical, a drinkable 5 ml 
ampoule containing 1 g of arginine-aspartate 
as the single active ingredient, excipients and 
sodium, and a product presented in the form 
of a powder to make a drinkable solution, 
contained in sachets, and a drinkable solu­
tion in the form of ampoules, containing 3 g 
of arginine-glutamate (the active ingredient 
of the product, with the same therapeutic 
effects as arginine-aspartate), the second 
product having practically the same compo­
sition as the first product and identical thera­
peutic indications, cannot be classified under 
heading 3004 of the Combined Nomencla­
ture, and consequently do not come within 
the scope of Regulation N o 1010/86 laying 
down general rules for the production 
refund on certain sugar products used in the 
chemical industry, when it has not been 
established that the products had clearly 
defined therapeutic or prophylactic charac­
teristics with an effect concentrated on pre­
cise functions of the human organism or that 
they were capable of being applied in the 
prevention or treatment of specific diseases 
or ailments. 
Nor, for identical reasons, can a product 
marketed in a drinkable solution put up in 5 
or 10 ml ampoules, one 5 ml ampoule con­
taining 15 µg of vitamin B 12 and a 10 ml 
ampoule double that quantity and in addi­
tion amino acids and preservatives, or a 
product presented in the form of drinkable 
ampoules for adults of 5 or 10 ml, its com­
position including 500 µg of vitamin B 12 
per ampoule of 10 ml and 250 µg of vitamin 
B 12 per ampoule of 5 ml and also contain­
ing amino acids and preservatives, be classi­
fied under heading 3004 and consequently 
those products do not come within the scope 
of Regulation N o 1010/86. 
Neither the fact that, pursuant to the provi­
sions of Directive 65/65 on medicinal prod­
ucts, marketing authorisations were granted 
for those products as 'medicinal products' by 
the competent national authorities, nor the 
fact that those products are regarded as such 
under that State's legislation, nor the presen­
tation of the products is a deciding factor in 
so far as the classification of such products is 
concerned. 
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