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Kuzey Makedonya3004 · 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
See additional note 1 to this chapter.
Unlike the previous heading, this heading covers ‘unmixed products’. For the interpretation of the term ‘unmixed products’, see note 3(a) to this chapter and the HS Explanatory Note to heading 3004, fourth and fifth paragraphs.
The terms ‘in measured doses (including those in the form of transdermal administration systems)’ and ‘forms or packings for retail sale for therapeutic or prophylactic uses’ are defined in the HS Explanatory Note to heading 3004, first and second paragraphs.
Medicaments put up in packings for long-term administration or for hospitals and similar establishments are included here. In this case, a larger number of units of the product is contained and the intended long-term administration or hospital use is generally indicated on the packing.
The fact that medicaments containing, for example, antibiotics, hormones or lyophilised products, and put up in ampoules or bottles must still have added to them pyrogen-free water or another diluent before being administered, does not exclude them from this heading.
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 |
| α-lipoic acid or thioctic acid | 0,6 | g | parenteral |
| Glucosamine sulfate | 1,5 (*) | g | oral |
| Levocarnitine | 2 | g | oral |
| Levocarnitine | 2 | g | parenteral |
| Lovastatin | 45 | mg | oral |
| Melatonin | 2 | mg | oral |
| N-acetylcysteine | 0,5 | g | oral |
| Yohimbine | 15 | mg | oral |
(*) The DDD of 1.5 g for “glucosamine sulfate” in the ATC-DDD index is based on the substance bis(2-ammonio-2-deoxy-D-glucose)sulfate (CAS RN 14999-43-0; Molecular Formula (C6H13NO5)2·H2SO4; Mw 456.42 g/mol).