Relief from Customs Duty and VAT on the importation of certain substances of a therapeutic or medical-related nature

1. Introduction

Certain substances of a therapeutic or medical-related nature may be imported from non-European Community (EC) countries without payment of Customs Duty and VAT. This leaflet describes the substances involved, the relief available and the procedures involved at import.

2. Relief Available

Therapeutic substances of human origin, blood-grouping reagents and tissue-typing reagents, together with any special packaging essential for their transport or solvents and accessories needed for their use, may be imported free from payment of Customs Duty and VAT on the following conditions:

  1. They are intended for institutions or laboratories approved by Revenue, for use exclusively for non-commercial medical or scientific purposes;
  2. They are accompanied by a certificate of conformity issued by a duly authorised body in the non-EC country of departure; and
  3. They are in containers bearing a special label identifying them.

3. Definitions

Therapeutic substances of human origin – means human blood and its derivatives (whole human blood, dried human plasma, human albumin and fixed solutions of human plasmic 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. (A reagent is a substance used to produce a chemical reaction); and

Tissue-typing reagents – means all reagents whether of human, animal, plant or other origin used for the determination of human tissue-types.

4. Prior Approval Required

Importers claiming the relief should apply to Customs Procedures Branch, Government Offices, St. Conlons Rd., Nenagh, for initial approval before any importation is undertaken.

5. Procedure at importation

Where goods are forwarded by post, the importer needs to ensure that the declaration on the parcel is endorsed as follows by the person sending the goods:

"Therapeutic Substances & Reagents: Exemption from import charges claimed".

The documentary evidence referred to below should be attached to the outside of the parcel and marked 'Customs Documents'.

Where goods are imported other than by post, they should be presented to Revenue accompanied by an import declaration (SAD) containing a claim to relief from Customs Duty and VAT. For the purposes of completion of the SAD, the legal references are:

Article 54 of Regulation (EC) No. 1186/2009 for Customs Duty;

Article 36 of Directive 83/181/EEC for VAT

In order to avail of relief from Customs Duty and VAT the following codes should be entered on the SAD:

Code C16 should be entered in box 37 b.

Code 1D09 should be entered in box 44/1

The authorisation number issued by Customs Procedures Branch, Nenagh should be entered in box 44/2

The entry should be accompanied by the documentary evidence outlined in paragraph 6.

6. Documentary evidence

The following documentary evidence should be presented to Revenue at the time of importation:

  1. A letter of authorisation from Customs Procedures Branch, Nenagh;
  2. A letter of declaration from the importer that the goods are exclusively for non commercial medical or scientific purposes; and
  3. A certificate of conformity issued by a duly authorised body in the third country of departure.

7. Further Information

Enquiries regarding any issue contained in this Information Leaflet should be addressed to the Revenue District responsible for your tax affairs. Contact details for all Revenue Districts can be found on the Contact Details Page.

Customs Division,
Customs Procedures Branch,
Government Offices,
Nenagh,
Co. Tipperary.

June 2010

Legal Disclaimer

While every effort is made to ensure that the information given in this guide is accurate, it is not a legal document. Responsibility cannot be accepted for any liability incurred or loss suffered as a consequence of relying on any matter published herein.

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