Diario Oficial de la Unión Europea del 8/6/2023 - Comunicaciones e Informaciones
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Source: Diario Oficial de la Unión Europea - Comunicaciones e Informaciones
EN
C 200/2
Official Journal of the European Union
8.6.2023
Explanatory Notes to the Combined Nomenclature of the European Union 2023/C 200/02
Pursuant to Article 91a of Council Regulation EEC No 2658/87 1, the Explanatory Notes to the Combined Nomenclature of the European Union 2 are hereby amended as follows:
On page 169, in the Explanatory note to CN heading 3004 Medicaments excluding goods of heading 3002, 3005 or 3006
consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses including those in the form of transdermal administration systems or in forms or packings for retail sale, delete the sixth and seventh paragraph and the table and its caption thereafter and substitute with the following text:
The heading includes, inter alia, preparations containing a sufficient quantity of active substances per daily dose e.g.
hormones or co-factors to provide therapeutic or prophylactic effects against a specific disease or ailment. The daily dose is recommended on the label, packaging or on the accompanying user directions of such products.
The index of Anatomical Therapeutic Chemicals WHO ATC-DDD index https www.whocc.no/atc_ddd_index/, developed by the World Health Organisation WHO, indicates the Defined Daily Dose DDD providing therapeutic or prophylactic effect when applied in quantities equal to or exceeding the amounts listed in that index.
The following table shows the DDD for the substances listed:
Name of the active substance
Defined Daily Dose
Unit
Administration route
0,6
g
oral
0,6
g
parenteral
1,5
g
oral
2
g
oral
2
g
parenteral
Lovastatin
45
mg
oral
Melatonin
2
mg
oral
N-acetylcysteine
0,5
g
oral
Yohimbine
15
mg
oral
-lipoic acid or thioctic acid
Glucosamine sulfate Levocarnitine
1 Council Regulation EEC No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff OJ L 256, 7.9.1987, p. 1.
2 OJ C 119, 29.3.2019, p. 1, as amended by OJ C 248, 24.7.2019, p. 3.
