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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

EU Regulation No 129/2007 · Adopted 12 February 2007 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 Tarifff1 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:

Annotations to the whole text

Footnotes

f1

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).

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4
  5. 5Article 5
  6. 6Article 6
  7. Signature
  8. Annex IList of international non-proprietary names (INNs) to be added to the list of products receiving duty-free treatment included in Annex 3 to Commission Regulation (EC) No 1549/2006
  9. Annex IIList of prefixes and suffixes which, in combination with the INNs of Annex 3 to Regulation (EC) No 1549/2006, describe the salts, esters or hydrates of INNs; these salts, esters and hydrates are free of duty, on condition that they are classifiable in the same six-digit HS-subheading as the corresponding INN
  10. Annex IIIList of pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to be added to the list of products receiving duty-free treatment included in Annex 6 to Regulation (EC) No 1549/2006
  11. Annex IVList of pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to be withdrawn from the list of products receiving duty-free treatment included in Annex 6 to Regulation (EC) No 1549/2006