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Council Regulation (EC) No 1110/1999 of 10 May 1999 providing for duty-free treatment of 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 pharmaceutical products Official Journal L 135 , 29/05/1999 P. 0001 - 0015

COUNCIL REGULATION (EC) No 1110/1999 of 10 May 1999 providing for duty-free treatment of 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 pharmaceutical products THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 113 thereof, Having regard to the proposal from the Commission, (1) Whereas, in the course of the Uruguay Round negotiations, the Community and a number of countries discussed duty-free treatment of pharmaceutical products; (2) Whereas the participants in those discussions concluded that, in addition to products falling within the Harmonised System (HS) Chapter 30 and HS Headings 2936, 2937, 2939 and 2941, duty-free treatment should be given to designated pharmaceutical active ingredients bearing an international non-proprietary name (INN) from the World Health Organisation, as well as specified salts, esters and hydrates of such products, and also to designated products used for the production and manufacture of finished pharmaceutical products; (3) Whereas 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 GATT 1994; (4) Whereas they also concluded that representatives of the World Trade Organisation (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; (5) Whereas the second such review has taken place with the conclusion that additional INNs and products used for production and manufacture of finished pharmaceutical products should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts and esters of INNs should be expanded, HAS ADOPTED THIS REGULATION: Article 1 As from 1 July 1999 the Community shall accord duty-free treatment for the INNs listed in Annex I as well as the salts, esters and hydrates of such products. Article 2 As from 1 July 1999 the Community shall accord duty-free treatment for the products used in the production and manufacture of finished pharmaceutical products listed in Annex II. Article 3 As from 1 July 1999 the specified prefixes and suffixes of INNs eligible for duty-free treatment shall include those listed in Annex III. Article 4 This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 10 May 1999. For the Council The President H. EICHEL ANNEX I Additional INNs to receive duty-free treatment >TABLE> ANNEX II Additional pharmaceutical intermediates, namely compounds used for the manufacture of finished pharmaceutical products, to receive duty-free treatment >TABLE> ANNEX III Additions to the list of prefixes and suffixes which, in combination with the INNs, describe salts, esters or hydrates of INNs Benzoate Difumarate Dipivoxil Monobenzoate Tetraisopropyl

COUNCIL REGULATION (EC) No 1110/1999

of 10 May 1999

providing for duty-free treatment of 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 pharmaceutical products

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 113 thereof,

Having regard to the proposal from the Commission,

(1) Whereas, in the course of the Uruguay Round negotiations, the Community and a number of countries discussed duty-free treatment of pharmaceutical products;

(2) Whereas the participants in those discussions concluded that, in addition to products falling within the Harmonised System (HS) Chapter 30 and HS Headings 2936, 2937, 2939 and 2941, duty-free treatment should be given to designated pharmaceutical active ingredients bearing an international non-proprietary name (INN) from the World Health Organisation, as well as specified salts, esters and hydrates of such products, and also to designated products used for the production and manufacture of finished pharmaceutical products;

(3) Whereas 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 GATT 1994;

(4) Whereas they also concluded that representatives of the World Trade Organisation (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;

(5) Whereas the second such review has taken place with the conclusion that additional INNs and products used for production and manufacture of finished pharmaceutical products should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts and esters of INNs should be expanded,

HAS ADOPTED THIS REGULATION:

Article 1

As from 1 July 1999 the Community shall accord duty-free treatment for the INNs listed in Annex I as well as the salts, esters and hydrates of such products.

Article 2

As from 1 July 1999 the Community shall accord duty-free treatment for the products used in the production and manufacture of finished pharmaceutical products listed in Annex II.

Article 3

As from 1 July 1999 the specified prefixes and suffixes of INNs eligible for duty-free treatment shall include those listed in Annex III.

Article 4

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

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

Done at Brussels, 10 May 1999.

For the Council

The President

H. EICHEL

ANNEX I

Additional INNs to receive duty-free treatment

>TABLE>

ANNEX II

Additional pharmaceutical intermediates, namely compounds used for the manufacture of finished pharmaceutical products, to receive duty-free treatment

>TABLE>

ANNEX III

Additions to the list of prefixes and suffixes which, in combination with the INNs, describe salts, esters or hydrates of INNs

Benzoate

Difumarate

Dipivoxil

Monobenzoate

Tetraisopropyl