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:

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.
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.
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.
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.
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.
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.
Regulation (EEC) No 2658/87 should therefore be amended accordingly.
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

ANNEX I

**List of international non-proprietary names (INNs) to be added to the list of products receiving duty-free treatment included in Annex 3 to Annex I to Regulation (EEC) No 2658/87**
CN code	CAS RN	Name
2842 90 80	119175-48-3	fermagate
2843 90 90	759457-82-4	padeliporfin
2844 40 30	123748-56-1	iodofiltic acid ( 123I)
2904 10 00	21668-77-9	eprodisate
2906 19 00	199798-84-0	elocalcitol
2909 30 90	24150-24-1	terameprocol
2916 19 95	81485-25-8	peretinoin
2916 39 00	51543-40-9	tarenflurbil
2918 19 98	174022-42-5	bevirimat
2919 90 00	258516-89-1	fospropofol
2920 90 85	163133-43-5	naproxcinod
2921 19 99	3687-18-1	tramiprosate
2922 19 85	68392-35-8	afimoxifene
2922 19 85	753449-67-1	ronacaleret
2922 29 00	433265-65-7	faxeladol
2922 50 00	121524-08-1	amibegron
2922 50 00	329773-35-5	cinaciguat
2922 50 00	643094-49-9	fasobegron
2923 10 00	856676-23-8	choline fenofibrate
2924 29 98	847353-30-4	arbaclofen placarbil
2924 29 98	194785-19-8	bedoradrine
2924 29 98	194085-75-1	carisbamate
2924 29 98	254750-02-2	emricasan
2924 29 98	355129-15-6	eprotirome
2924 29 98	402567-16-2	firategrast
2924 29 98	478296-72-9	gabapentin enacarbil
2924 29 98	15866-90-7	incyclinide
2924 29 98	202844-10-8	indantadol
2924 29 98	96847-55-1	levomilnacipran
2924 29 98	608137-32-2	lisdexamfetamine
2924 29 98	652990-07-3	milveterol
2924 29 98	181816-48-8	ombrabulin
2924 29 98	289656-45-7	senicapoc
2925 19 95	19171-19-8	pomalidomide
2928 00 90	22033-87-0	olesoxime
2928 00 90	2675-35-6	sivifene
2928 00 90	816458-31-8	tecovirimat
2928 00 90	238750-77-1	tosedostat
2928 00 90	149647-78-9	vorinostat
2929 90 00	31645-39-3	palifosfamide
2930 90 99	608141-41-9	apremilast
2930 90 99	216167-92-9	camobucol
2930 90 99	211513-37-0	dalcetrapib
2930 90 99	69819-86-9	darinaparsin
2930 90 99	488832-69-5	elesclomol
2930 90 99	216167-95-2	elsibucol
2930 90 99	168682-53-9	ezatiostat
2930 90 99	58569-55-4	metenkefalin
2930 90 99	887148-69-8	monepantel
2930 90 99	603139-19-1	odanacatib
2930 90 99	162520-00-5	salirasib
2930 90 99	216167-82-7	succinobucol
2930 90 99	125961-82-2	tipelukast
2931 00 99	125973-56-0	amsilarotene
2932 19 00	253128-41-5	eribulin
2932 19 00	186953-56-0	pafuramidine
2932 29 85	195883-06-8	omtriptolide
2932 99 00	664338-39-0	arterolane
2932 99 00	183133-96-2	cabazitaxel
2932 99 00	401925-43-7	celivarone
2932 99 00	461432-26-8	dapagliflozin
2932 99 00	118457-15-1	dexnebivolol
2932 99 00	156294-36-9	larotaxel
2932 99 00	118457-16-2	levonebivolol
2932 99 00	83461-56-7	mifamurtide
2932 99 00	117570-53-3	vadimezan
2933 19 90	496775-61-2	eltrombopag
2933 19 90	206884-98-2	niraxostat
2933 19 90	410528-02-8	palovarotene
2933 19 90	376592-42-6	totrombopag
2933 29 90	183659-72-5	catramilast
2933 29 90	944263-65-4	demiditraz
2933 29 90	867153-61-5	dulanermin
2933 29 90	320367-13-3	lixisenatide
2933 29 90	698389-00-3	rolipoltide
2933 29 90	697766-75-9	velafermin
2933 39 99	147084-10-4	alcaftadine
2933 39 99	54-96-6	amifampridine
2933 39 99	249921-19-5	anamorelin
2933 39 99	319460-85-0	axitinib
2933 39 99	208110-64-9	befiradol
2933 39 99	330942-05-7	betrixaban
2933 39 99	201034-75-5	daporinad
2933 39 99	209783-80-2	entinostat
2933 39 99	412950-27-7	goxalapladib
2933 39 99	218791-21-0	imisopasem manganese
2933 39 99	103129-82-4	levamlodipine
2933 39 99	154357-42-3	levonadifloxacin
2933 39 99	108147-54-2	migalastat
2933 39 99	453562-69-1	motesanib
2933 39 99	139145-27-0	parogrelil
2933 39 99	459856-18-9	pexacerfont
2933 39 99	706779-91-1	pimavanserin
2933 39 99	362665-56-3	pitolisant
2933 39 99	861151-12-4	rosonabant
2933 39 99	701977-09-5	taranabant
2933 39 99	189950-11-6	tropantiol
2933 39 99	793655-64-8	vapitadine
2933 39 99	139290-65-6	volinaserin
2933 49 90	141388-76-3	besifloxacin
2933 49 90	697761-98-1	elvitegravir
2933 49 90	185055-67-8	ferroquine
2933 49 90	445041-75-8	intiquinatine
2933 49 90	378746-64-6	nemonoxacin
2933 49 90	245765-41-7	ozenoxacin
2933 49 90	412950-08-4	rilapladib
2933 49 90	871224-64-5	almorexant
2933 49 90	863029-99-6	balamapimod
2933 49 90	698387-09-6	neratinib
2933 49 90	154652-83-2	tezampanel
2933 49 90	128253-31-6	veliflapon
2933 59 95	791828-58-5	aderbasib
2933 59 95	840486-93-3	adipiplon
2933 59 95	850649-61-5	alogliptin
2933 59 95	859212-16-1	bafetinib
2933 59 95	380843-75-4	bosutinib
2933 59 95	839712-12-8	cariprazine
2933 59 95	414910-27-3	casopitant
2933 59 95	288383-20-0	cediranib
2933 59 95	849550-05-6	cevipabulin
2933 59 95	827318-97-8	danusertib
2933 59 95	356057-34-6	darapladib
2933 59 95	501000-36-8	dutacatib
2933 59 95	247257-48-3	fimasartan
2933 59 95	3432-99-3	folitixorin
2933 59 95	668270-12-0	linagliptin
2933 59 95	441798-33-0	macitentan
2933 59 95	641571-10-0	nilotinib
2933 59 95	763113-22-0	olaparib
2933 59 95	686344-29-6	otenabant
2933 59 95	625115-55-1	riociguat
2933 59 95	486460-32-6	sitagliptin
2933 59 95	425637-18-9	sotrastaurin
2933 59 95	309913-83-5	talmapimod
2933 59 95	113857-87-7	talotrexin
2933 59 95	274693-27-5	ticagrelor
2933 59 95	306296-47-9	vicriviroc
2933 69 80	775351-65-0	imeglimin
2933 79 00	461443-59-4	aplaviroc
2933 79 00	189691-06-3	bremelanotide
2933 79 00	813452-18-5	carmegliptin
2933 79 00	405169-16-6	dovitinib
2933 79 00	536748-46-6	eribaxaban
2933 79 00	473289-62-2	ilepatril
2933 79 00	180694-97-7	mimopezil
2933 79 00	579475-18-6	orvepitant
2933 79 00	449811-01-2	pamapimod
2933 79 00	248282-01-1	paquinimod
2933 79 00	380917-97-5	perampanel
2933 79 00	552292-08-7	rolapitant
2933 79 00	425386-60-3	semagacestat
2933 79 00	515814-01-4	voclosporin
2933 99 80	481629-87-2	aleplasinin
2933 99 80	394730-60-0	boceprevir
2933 99 80	649735-63-7	brivanib alaninate
2933 99 80	483369-58-0	denagliptin
2933 99 80	284019-34-7	denibulin
2933 99 80	481631-45-2	diaplasinin
2933 99 80	272105-42-7	disitertide
2933 99 80	227318-71-0	epetirimod
2933 99 80	259793-96-9	favipiravir
2933 99 80	871576-03-3	flovagatran
2933 99 80	229305-39-9	golotimod
2933 99 80	258818-34-7	larazotide
2933 99 80	571170-77-9	laropiprant
2933 99 80	616202-92-7	lorcaserin
2933 99 80	868771-57-7	melogliptin
2933 99 80	803712-67-6	obatoclax
2933 99 80	404950-80-7	panobinostat
2933 99 80	625114-41-2	piragliatin
2933 99 80	74847-35-1	pyronaridine
2933 99 80	872178-65-9	rabeximod
2933 99 80	355151-12-1	rotigaptide
2933 99 80	497221-38-2	rusalatide
2933 99 80	187602-11-5	sofigatran
2933 99 80	227318-75-4	sotirimod
2933 99 80	402957-28-2	telaprevir
2933 99 80	848084-83-3	tigapotide
2933 99 80	393105-53-8	tiplasinin
2933 99 80	620948-93-8	vabicaserin
2933 99 80	794466-70-9	vernakalant
2934 10 00	544417-40-5	capadenoson
2934 10 00	302962-49-8	dasatinib
2934 10 00	223132-37-4	inolitazone
2934 10 00	241479-67-4	isavuconazole
2934 10 00	338990-84-4	isavuconazonium chloride
2934 10 00	607723-33-1	lobeglitazone
2934 10 00	280782-97-0	managlinat dialanetil
2934 10 00	790299-79-5	masitinib
2934 10 00	223673-61-8	mirabegron
2934 10 00	501948-05-6	rosabulin
2934 10 00	447406-78-2	sodelglitazar
2934 10 00	760937-92-6	teneligliptin
2934 20 80	848344-36-5	bentamapimod
2934 20 80	870093-23-5	talarozole
2934 99 90	320345-99-1	aclidinium bromide
2934 99 90	222551-17-9	adoprazine
2934 99 90	207623-20-9	agatolimod
2934 99 90	475479-34-6	aleglitazar
2934 99 90	870524-46-2	amolimogene bepiplasmid
2934 99 90	875446-37-0	anacetrapib
2934 99 90	250386-15-3	apadenoson
2934 99 90	541550-19-0	apilimod
2934 99 90	160707-69-7	apricitabine
2934 99 90	147403-03-0	azilsartan
2934 99 90	863031-21-4	azilsartan medoxomil
2934 99 90	757942-43-1	bederocin
2934 99 90	627861-07-8	beperminogene perplasmid
2934 99 90	959961-96-7	bevasiranib
2934 99 90	769901-96-4	capeserod
2934 99 90	868540-17-4	carfilzomib
2934 99 90	872847-66-0	cenersen
2934 99 90	80295-38-1	conestat alfa
2934 99 90	903916-27-8	custirsen
2934 99 90	187865-22-1	derquantel
2934 99 90	134379-77-4	dexelvucitabine
2934 99 90	247046-52-2	dilopetine
2934 99 90	480449-70-5	edoxaban
2934 99 90	188181-42-2	elacytarabine
2934 99 90	98819-76-2	esreboxetine
2934 99 90	763903-67-9	fosalvudine tidoxil
2934 99 90	172673-20-0	fosaprepitant
2934 99 90	522664-63-7	ibodutant
2934 99 90	405159-59-3	idrabiotaparinux sodium
2934 99 90	188116-07-6	imepitoin
2934 99 90	335619-18-6	inakalant
2934 99 90	1391-36-2	lancovutide
2934 99 90	189059-71-0	lapaquistat
2934 99 90	327026-93-7	lensiprazine
2934 99 90	170632-47-0	lificiguat
2934 99 90	852313-25-8	litenimod
2934 99 90	1000120-98-8	mipomersen
2934 99 90	62253-63-8	nepidermin
2934 99 90	26833-87-4	omacetaxine mepesuccinate
2934 99 90	269718-84-5	pardoprunox
2934 99 90	219923-85-0	pramiconazole
2934 99 90	377727-87-2	preladenant
2934 99 90	524684-52-4	prinaberel
2934 99 90	865311-47-3	quarfloxin
2934 99 90	869884-78-6	radezolid
2934 99 90	496054-87-6	radiprodil
2934 99 90	518048-05-0	raltegravir
2934 99 90	787548-03-2	regrelor
2934 99 90	820957-38-8	retosiban
2934 99 90	572924-54-0	ridaforolimus
2934 99 90	128517-07-7	romidepsin
2934 99 90	93265-81-7	ropidoxuridine
2934 99 90	151823-14-2	sapacitabine
2934 99 90	379231-04-6	saracatinib
2934 99 90	791635-59-1	simotaxel
2934 99 90	119567-79-2	taribavirin
2934 99 90	332012-40-5	telatinib
2934 99 90	925681-61-4	trabedersen
2934 99 90	189003-92-7	trelanserin
2934 99 90	296251-72-4	velimogene aliplasmid
2934 99 90	904302-98-3	viquidacin
2934 99 90	872525-61-6	votucalis
2934 99 90	221877-54-9	zotarolimus
2935 00 90	197904-84-0	apricoxib
2935 00 90	769169-27-9	begacestat
2935 00 90	414864-00-9	belinostat
2935 00 90	313682-08-5	brecanavir
2935 00 90	839673-52-8	cevoglitazar
2935 00 90	358970-97-5	drinabant
2935 00 90	865200-20-0	giripladib
2935 00 90	464213-10-3	ibipinabant
2935 00 90	173424-77-6	laromustine
2935 00 90	398507-55-6	lodenafil carbonate
2935 00 90	136564-68-6	masilukast
2935 00 90	170569-88-7	mavacoxib
2935 00 90	862189-95-5	mirodenafil
2935 00 90	439687-69-1	nelivaptan
2935 00 90	691852-58-1	nesbuvir
2935 00 90	778576-62-8	oglemilast
2935 00 90	444731-52-6	pazopanib
2935 00 90	362505-84-8	relacatib
2935 00 90	243984-11-4	resatorvid
2935 00 90	519055-62-0	tasisulam
2935 00 90	186497-07-4	zibotentan
2936 29 00	104121-92-8	eldecalcitol
2936 29 00	31690-09-2	levomefolic acid
2937 19 00	782500-75-8	albiglutide
2937 19 00	348119-84-6	obinepitide
2937 19 00	295350-45-7	ozarelix
2937 19 00	275371-94-3	taspoglutide
2937 19 00	218949-48-5	tesamorelin
2937 19 00	22006-64-0	tridecactide
2937 22 00	132245-57-9	dexamethasone cipecilate
2937 22 00	397864-44-7	fluticasone furoate
2937 29 00	211254-73-8	lonaprisan
2937 50 00	333963-42-1	cobiprostone
2937 50 00	172740-14-6	posaraprost
2937 90 00	834153-87-6	elagolix
2937 90 00	609799-22-6	tasimelteon
2937 90 00	342577-38-2	velneperit
2939 19 00	73232-52-7	methylnaltrexone bromide
2939 59 00	136199-02-5	rolofylline
2939 99 00	850607-58-8	darotropium bromide
2939 99 00	187852-63-7	delimotecan
2940 00 00	9007-72-1	ferric carboxymaltose
2940 00 00	442201-24-3	remogliflozin etabonate
2940 00 00	408504-26-7	sergliflozin etabonate
2941 90 00	467214-20-6	alvespimycin
2941 90 00	677017-23-1	berubicin
2941 90 00	229016-73-3	ceftaroline fosamil
2941 90 00	318498-76-9	flopristin
2941 90 00	145435-72-9	gamithromycin
2941 90 00	325965-23-9	linopristin
2941 90 00	857402-23-4	retaspimycin
2941 90 00	305841-29-6	sagopilone
2941 90 00	75747-14-7	tanespimycin
2941 90 00	328898-40-4	tildipirosin
2941 90 00	222400-20-6	tomopenem
2941 90 00	63409-12-1	tylvalosin
3001 90 91	9041-08-1	semuloparin sodium
3002 10 91	792921-10-9	abagovomab
3002 10 91	910649-32-0	anrukinzumab
3002 10 91	648904-28-3	bavituximab
3002 10 91	402710-27-4 (light chain) 402710-25-2 (heavy chain)	canakinumab
3002 10 99	945228-49-9	citatuzumab bogatox
3002 10 91	880486-59-9	dacetuzumab
3002 10 91	615258-40-7	denosumab
3002 10 91	762260-74-2	efungumab
3002 10 91	89957-37-9	gantenerumab
3002 10 91	680188-33-4	ibalizumab
3002 10 91	477202-00-9	ipilimumab
3002 10 91	640735-09-7	iratumumab
3002 10 91	845816-02-6	lexatumumab
3002 10 91	903512-50-5	lucatumumab
3002 10 91	899796-83-9	milatuzumab
3002 10 91	677010-34-3	motavizumab
3002 10 91	676258-98-3	naptumomab estafenatox
3002 10 91	828933-51-3	nimotuzumab
3002 10 91	949142-50-1	obinutuzumab
3002 10 91	637334-45-3	ocrelizumab
3002 10 91	881191-44-2	otelixizumab
3002 10 91	372075-37-1	sontuzumab
3002 10 91	705287-60-1	stamulumab
3002 10 91	339086-80-5	tadocizumab
3002 10 91	592557-43-2 (light chain) 592557-41-0 (heavy chain)	tenatumomab
3002 10 91	876387-05-2	teplizumab
3002 10 91	918127-53-4	tigatuzumab
3002 10 91	745013-59-6	tremelimumab
3002 10 91	339986-90-2	tucotuzumab celmoleukin
3002 10 91	728917-18-8	veltuzumab
3002 10 91	896731-82-1	conatumumab
3002 10 91	892553-42-3	etaracizumab
3002 10 91	944548-38-3	foravirumab
3002 10 91	944548-37-2	rafivirumab
3002 10 91	880266-57-9	tanezumab
3002 10 91	815610-63-0	ustekinumab
3002 10 95	862111-32-8	aflibercept
3002 10 95	845264-92-8	atacicept
3002 10 95	909110-25-4	baminercept
3002 10 95	9001-27-8	beroctocog alfa
3002 10 95	879555-13-2	epoetin kappa
3002 10 95	762263-14-9	epoetin theta
3002 10 95	501081-76-1	rilonacept
3002 10 95	267639-76-9	romiplostim
3002 10 95	869858-13-9	thrombin alfa
3002 10 95	897936-89-9	vatreptacog alfa (activated)
3002 10 95	472960-22-8	albinterferon alfa-2b
3002 10 95	869881-54-9	briobacept
3002 10 95	606138-08-3	catridecacog
3002 10 95	716840-32-3	denenicokin
3002 10 95	931101-84-7	troplasminogen alfa
3002 10 99	934216-54-3	alacizumab pegol
3002 20 00	181477-43-0	disomotide
3002 20 00	181477-91-8	ovemotide
3002 20 00	915019-08-8	tertomotide
3002 20 00	295371-00-5	verpasep caltespen
3002 90 90	473553-86-5	alferminogene tadenovec
3002 90 90	929881-05-0	alipogene tiparvovec
3002 90 90	600735-73-7	contusugene ladenovec
3002 90 90	851199-59-2	linaclotide
3002 90 90	898830-54-1	sitimagene ceradenovec
3002 90 90	721946-42-5	transferrin aldifitox
3507 90 90	9026-00-0	bucelipase alfa
3507 90 90	885051-90-1	pegloticase
3507 90 90	884604-91-5	velaglucerase alfa
3911 90 99	892497-01-7	azoximer bromide

Article 1

Article 2

ANNEX I

ANNEX II

ANNEX III

ANNEX IV