COUNCIL REGULATION (EC) No 467/97 of 3 March 1997 providing for 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 and withdrawing duty-free treatment as pharmaceutical products from certain INNs whose predominant use is not pharmaceutical

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,

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

Whereas the participants in those discussions concluded that in addition to products falling within the Harmonized 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 Organization as well as specified salts, esters and hydrates of such INNs, and also to designated products used for the production and manufacture of finished products;

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;

Whereas they also concluded that representatives of the 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;

Whereas the first such review has taken place with the conclusion that a certain number of additional INNs and products used for production and manufacture of finished pharmaceuticals should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts and esters of INNs should be expanded;

Whereas in the context of the review it was concluded that it was appropriate to rectify the situation with regard to certain INNs whose use was predominantly non-pharmaceutical and which had been inadvertently included among those INNs already receiving duty-free treatment,

HAS ADOPTED THIS REGULATION:

Article 1

From 1 April 1997 the Community shall also accord duty-free treatment for the INNs listed in Annex I as well as the salts, esters and hydrates of such products.

Article 2

From 1 April 1997 the Community shall also grant duty-free treatment for the products used in the production and manufacture of pharmaceutical products listed in Annex II.

Article 3

From 1 April 1997 the specified prefixes and suffixes of INNs eligible for duty-free treatment shall also include those listed in Annex III.

Article 4

From 1 April 1997 the products listed in Annex IV together with the salts, esters and hydrates of such products shall no longer benefit from duty-free treatment.

Article 5

This Regulation shall enter into force on the 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, 3 March 1997.

For the Council

The President

M. DE BOER

ANNEX I

Additional INNs to receive duty-free treatment

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ANNEX II

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

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ANNEX III

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

N-acetylglycinate

acistrate

acoxil

amsonate

benzathine

bezomil

buciclate

bunapsilate

buteprate

butyl ester

carbesilate

p-chlorobenzenesulfonate

p-chlorobenzenesulphonate

ciclotate

cipionate

closilate

closylate

crobefate

cromacate

cromesilate

cyclopentanepropionate

cyclotate

cypionate

dapropate

deanil

decil

dibudinate

dibunate

diethanolamine

digolil

N,N-dimethyl-beta-alanine

diolamine

docosil

dofosfate

edamine

edisylate

epolamine

erbumine

etabonate

ethanolamine

ethylenediamine

farnesil

fendizoate

fostedate

hibenzate

hybenzate

hyclate

o-(4-hydroxybenzoyl)benzoate

isocaproate

lauril

laurilsulfate

laurilsulphate

lauryl

laurylsulfate

laurylsulphate

megallate

metembonate

4-methylbicyclo[2.2.2]oct-2-ene-1-carboxylate

mofetil

octil

olamine

oxoglurate

pendetide

pivoxetil

proxetil

1-pyrrolidineethanol

sodium lauril sulfate

sodium lauril sulphate

sodium lauryl sulfate

sodium lauryl sulphate

steaglate

tenoate

teprosilate

tetradecyl hydrogen phosphate

tofesilate

triclofenate

triethanolamine

triflutate

trolamine

trometamol

tromethamine

troxundate

xinafoate

ANNEX IV

INNs which shall no longer benefit from duty-free treatment

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