9 Therapeutic substances, medicines, laboratory animals and biological or chemical substances

(1) Subject to paragraph (2), tax shall not be charged on the importation of the following goods:

(a) live animals specially prepared and sent free of charge for laboratory use;

(b) biological or chemical substances which are imported from countries outside the Community subject to the limits and conditions laid down in Article 53 of Council Regulation (EC) No. 1186/2009 of 16 November 2009¹;

(c) therapeutic substances of human origin, being 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);

(d) blood-grouping reagents whether of human, animal, plant or other origin used for blood-type grouping and for the detection of blood incompatibilities;

(e) tissue-typing reagents whether of human, animal, plant or other origin used for the determination of human tissue-types;

(f) pharmaceutical products for human or veterinary medical use by persons or animals participating in international sports events, within the limits necessary to meet their requirements during their stay in the State;

(g) consignments which contain samples of reference substances approved by the World Health Organisation for the quality control of materials used in the manufacture of medicinal products and which are addressed to consignees authorised by the Revenue Commissioners to receive such consignments free of tax.

(2) (a) Relief under paragraph (1)(a) or (b) shall apply only to animals and biological and chemical substances intended for—

(i) public establishments, or departments of public establishments, principally engaged in education or scientific research, or

(ii) private establishments principally engaged in education or scientific research which are approved by the Revenue Commissioners for the purposes of this Regulation.

(b) Relief under paragraph (1)(c), (d) or (e) shall apply only to—

(i) goods that are—

(I) intended for institutions or laboratories approved by the Revenue Commissioners for the purposes of this Regulation for use exclusively for non-commercial medical or scientific purposes,

(II) accompanied by a certificate of conformity of a duly authorised body in the country of departure, and

(III) in containers bearing a special label identifying them,

(ii) special packaging essential for the transport of therapeutic substances of human origin or blood-grouping or tissue-typing reagents, and

(iii) solvents and accessories needed for the use of the substances referred to in clause (ii) and included in consignments of the goods.