LegalizeRegulation (EU) No 1238/2010 of the European Parliament and of the Council of 15 December 2010 amending Annex I to Council Regulation (EEC) No 2658/87 as regards the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Acting in accordance with the ordinary legislative procedure (1),
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 Organization, specified salts, esters and hydrates of such INNs, and designated pharmaceutical intermediates used for the production and manufacture of finished pharmaceuticals.
(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 General Agreement on Tariffs and Trade (GATT) 1994.
(3) Participants concluded that representatives of World Trade Organization (WTO) members, party to the Record of Discussions, would meet under the auspices of the Council for Trade in Goods of the WTO, 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) Three such reviews have taken place with the result that a certain number of additional INNs and pharmaceutical intermediates used for the production and manufacture of finished pharmaceuticals have been granted duty-free treatment, that some of those intermediates have been transferred to the list of INNs, and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs has been expanded.
(5) A fourth review was deemed appropriate and was launched in 2009. It concluded that a certain number of additional INNs and pharmaceutical intermediates used for the production and manufacture of finished pharmaceuticals should be granted duty-free treatment, that some of those intermediates already included in the pharmaceutical sectoral arrangement and its revisions 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.
(6) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (2) established the Combined Nomenclature (CN) and set out the conventional duty rates of the Common Customs Tariff.
(7) Regulation (EEC) No 2658/87 should therefore be amended accordingly.
(8) In order to ensure that the measures provided for in this Regulation apply from 1 January 2011, it should enter into force on the day following that of its publication,
HAVE ADOPTED THIS REGULATION:
Article 1
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) are hereby amended as follows:
As from 1 January 2011 the Union shall extend duty-free treatment to the INNs listed in Annex I.
As from 1 January 2011 the list of prefixes and suffixes which, in combination with the INNs included in the pharmaceutical sectoral arrangement and its revisions, 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 amended as set out in Annex II.
As from 1 January 2011 the Union shall extend duty-free treatment to the pharmaceutical intermediates used in the production and manufacture of finished pharmaceuticals, listed in Annex III.
As from 1 January 2011 the pharmaceutical intermediates listed in Annex IV shall be withdrawn from the list of such compounds receiving duty-free treatment.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 15 December 2010.
For the European Parliament The President J. BUZEK
For the Council The President O. CHASTEL
(1) Position of the European Parliament of 23 November 2010 (not yet published in the Official Journal) and decision of the Council of 10 December 2010.
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