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Document 52023XC0608(01)
Explanatory Notes to the Combined Nomenclature of the European Union 2023/C 200/02
Explanatory Notes to the Combined Nomenclature of the European Union 2023/C 200/02
Explanatory Notes to the Combined Nomenclature of the European Union 2023/C 200/02
C/2023/3754
OJ C 200, 8.6.2023, p. 2–2
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
8.6.2023 |
EN |
Official Journal of the European Union |
C 200/2 |
Explanatory Notes to the Combined Nomenclature of the European Union
(2023/C 200/02)
Pursuant to Article 9(1)(a) 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 |
|
α-lipoic acid or thioctic acid |
0,6 |
g |
oral |
|
0,6 |
g |
parenteral |
|
|
Glucosamine sulfate |
1,5 |
g |
oral |
|
Levocarnitine |
2 |
g |
oral |
|
2 |
g |
parenteral |
|
|
Lovastatin |
45 |
mg |
oral |
|
Melatonin |
2 |
mg |
oral |
|
N-acetylcysteine |
0,5 |
g |
oral |
|
Yohimbine |
15 |
mg |
oral’ |
(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.