Council Regulation (EC) No 129/2007 of 12 February 2007 providing for duty-free treatment for specified pharmaceutical active ingredients bearing an international non-proprietary name (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and amending Annex I to Regulation (EEC) No 2658/87

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 133 thereof,

Having regard to the proposal from the Commission,

Whereas:

(1) In the course of the Uruguay Round negotiations, the Community and a number of countries agreed that duty-free treatment should be granted to pharmaceutical products falling within the Harmonised System (HS) Chapter 30 and HS headings 2936, 2937, 2939 and 2941 as well as to designated pharmaceutical active ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organisation, specified salts, esters or hydrates of such INNs, and designated intermediates used for the production and manufacture of finished products.

(2) The results of the discussions, as set out in the record of discussions, were incorporated into the tariff schedules of the participants, annexed to the Marrakesh Protocol to the GATT 1994.

(3) Participants concluded that representatives of the WTO members, party to the record of discussions, would meet under the auspices of the WTO Council for Trade in Goods, normally at least once every three years to review the product coverage with a view to including, by consensus, additional pharmaceutical products for tariff elimination.

(4) In the course of three such reviews it was concluded that a certain number of additional INNs and intermediates used for production and manufacture of finished pharmaceuticals should be granted duty-free treatment, that certain of these intermediates should be transferred to the list of INNs, and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs should be expanded.

(5) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1) established the Combined Nomenclature (CN) and set out the conventional duty rates of the Common Customs Tariff.

(6) Regulation (EEC) No 2658/87 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

As from 1 January 2007 the Community shall extend duty-free treatment to the INNs listed in Annex I.

Article 2

As from 1 January 2007 the list of prefixes and suffixes which, in combination with the INNs, describe the salts, esters or hydrates of INNs which are also eligible for duty-free treatment, on condition that they are classifiable in the same six-digit HS-subheading as the corresponding INN, shall be replaced by the list in Annex II.

Article 3

As from 1 January 2007 the Community shall extend duty-free treatment to the intermediates used in the production and manufacture of pharmaceutical products listed in Annex III.

Article 4

As from 1 January 2007 the intermediates listed in Annex IV shall no longer benefit from duty-free treatment.

Article 5

Annexes 3, 4 and 6 of Section II of Part three of Annex I to Regulation (EEC) No 2658/87 (Lists of pharmaceutical substances which qualify for duty-free treatment) shall be amended accordingly.

Article 6

This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 February 2007.

For the Council The President F.-W. STEINMEIER

(1) OJ L 256, 7.9.1987, p. 1. Regulation as last amended by Regulation (EC) No 1930/2006 (OJ L 406, 30.12.2006, p. 9).