CHAPTER 2

Without prejudice to the exemption provided for in Article 143(a) of Directive 2006/112/EC and subject to Article 38 of this Directive, the following shall be exempted: therapeutic substances of human origin; blood-grouping reagents; tissue-typing reagents. For the purposes of paragraph 1: ‘therapeutic substances of human origin’ means human blood and its derivatives (whole human blood, dried human plasma, human albumin and fixed solutions of human plasma protein, human immunoglobulin and human fibrinogen); ‘blood-grouping reagents’ means all reagents, whether of human, animal, plant or other origin used for blood-type grouping and for the detection of blood incompatibilities; ‘tissue-typing reagents’ means all reagents whether of human, animal, plant or other origin used for the determination of human tissue-types. Exemption shall be limited to products which: are intended for institutions or laboratories approved by the competent authorities, for use exclusively for non-commercial medical or scientific purposes; are accompanied by a certificate of conformity issued by a duly authorised body in the country or territory of departure; are in containers bearing a special label identifying them. Exemption shall include the special packaging essential for the transport of therapeutic substances of human origin or blood-grouping or tissue-typing reagents and also any solvents and accessories needed for their use which may be included in the consignments.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-12 · Text as adopted (Official Journal); later amendments are not incorporated in this text.