Regulation (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

DOUEEN, December 31, 2010 › Serie L

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L 348/36 Official Journal of the European Union 31.12.2010

REGULATION (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

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) established the Combined Nomenclature...

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