Document ID: 31997R0467

Reference:
13.3.1997
EN
Official Journal of the European Communities
L 71/1
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
CN code
CAS RN
Name
2844 40 30
113716-48-6
Iolopride (123 I)
142481-95-6
Technetium (99m Tc) furifosmin
2846 90 00
131069-91-5
Gadoversetamide
135326-11-3
Gadoxetic acid
138721-73-0
Sprodiamide
2914 40 90
20098-14-0
Idramantone
2916 39 00
71109-09-6
Vedaprofen
2918 30 00
22161-81-5
Dexketoprofen
112665-43-7
Seratrodast
2918 90 90
139403-31-9
Pimilprost
2921 49 90
136236-51-6
Rasagiline
2922 49 70
6582-31-6
Dapabutan
2923 90 00
1794-75-8
Laurcetium bromide
2924 10 00
1675-66-7
Adelmidrol
62304-98-7
Thymalfasin
132787-19-0
Tradecamide
129009-83-2
Versetamide
2924 29 90
147362-57-0
Loviride
94497-51-5
Tamibarotene
2925 19 80
144849-63-8
Bisnafide
2925 20 00
137159-92-3
Aptiganel
2926 90 80
137109-71-8
Balazipone
147076-36-6
Laflunimus
2928 00 90
141579-54-6
Fenleuton
2930 90 16
87573-01-1
Salnacedin
2930 90 70
90357-06-5
Bicalutamide
112573-72-5
Dexecadotril
107023-41-6
Pobilukast
81110-73-8
Racecadotril
2931 00 50
132236-18-1
Zifrosilone
2931 00 80
114084-78-5
Ibandronic acid
124351-85-5
Incadronic acid
63132-39-8
Olpadronic acid
2932 99 70
105674-77-9
Lanproston
2932 99 90
123407-36-3
Arteflene
132017-01-7
Bervastatin
110816-79-0
Cromoglicate lisetil
149494-37-1
Ebalzotan
151581-24-7
Iralukast
113806-05-6
Olopatadine
139110-80-8
Zanamivir
2933 29 90
158682-68-9
Elisartan
116684-92-5
Galdansetron
89371-44-8
Imidaprilat
138402-11-6
Irbesartan
118072-93-8
Zoledronic acid
2933 39 95
119257-34-0
Besipirdine
118248-91-2
Fodipir
155415-08-0
Inogatran
121750-57-0
Itameline
144412-49-7
Lamifiban
155319-91-8
Mangafodipir
150443-71-3
Nicanartine
29876-14-0
Nicotredole
144035-83-6
Piclamilast
137795-35-8
Spiroglumide
147025-53-4
Talsaclidine
149488-17-5
Trovirdine
2933 40 10
127294-70-6
Balofloxacin
143383-65-7
Premafloxacin
143224-34-4
Telinavir
2933 40 90
96946-42-8
Cisatracurium besilate
158966-92-8
Montelukast
136668-42-3
Quiflapon
2933 59 70
127266-56-2
Adatanserin
106941-25-7
Adefovir
113852-37-2
Cidofovir
150756-35-7
Efletirizine
119687-33-1
Iganidipine
127759-89-1
Lobucavir
140945-32-0
Mapinastine
134208-17-6
Mazapertine
96604-21-6
Ocinaplon
148504-51-2
Ripisartan
115762-17-9
Ruzadolane
118420-47-6
Tagorizine
137234-62-9
Voriconazole
151319-34-5
Zaleplon
2933 79 00
148396-36-5
Fradafiban
74436-00-3
Geclosporin
143943-73-1
Lirequinil
106730-54-5
Olprinone
135548-15-1
Oxeclosporin
145733-36-4
Tasosartan
143343-83-3
Toborinone
2933 90 95
137882-98-5
Abitesartan
114607-46-4
Acitazanolast
120511-73-1
Anastrozole
134523-00-5
Atorvastatin
128270-60-0
Bivalirudin
139481-59-7
Candesartan
54278-85-2
Candocuronium iodide
105806-65-3
Efegatran
62568-57-4
Emideltide
120081-14-3
Goralatide
142880-36-2
Ilornastat
62732-44-9
Ipidacrine
116287-14-0
Lanperisone
112809-51-5
Letrozole
116644-53-2
Mibefradil
136122-46-8
Mipitroban
144702-17-0
Pomisartan
132036-88-5
Ramosetron
106308-44-5
Rufinamide
144701-48-4
Telmisartan
147059-72-1
Trovafloxacin
2934 10 00
149079-51-6
Cartasteine
128312-51-6
Cinalukast
51287-57-1
Denotivir
101001-34-7
Pamicogrel
136433-51-7
Tazofelone
138742-43-5
Zankiren
2934 20 90
144665-07-6
Lubeluzole
150915-41-6
Perospirone
146939-27-7
Ziprasidone
2934 90 60
130370-60-4
Batimastat
133040-01-4
Eprosartan
135202-79-8
Ilonidap
114686-12-3
Imitrodast
132418-36-1
Rocepafant
132418-35-0
Setipafant
2934 90 70
125533-88-2
Mofarotene
127045-41-4
Pazufloxacin
2934 90 80
118292-40-3
Tazarotene
2934 90 98
151356-08-0
Afovirsen
138298-79-0
Alnespirone
152317-89-0
Alniditan
153420-96-3
Atibeprone
143393-27-5
Azalanstat
149908-53-2
Azimilide
150490-85-0
Berupipam
154361-50-9
Capecitabine
133099-04-4
Darifenacin
137500-42-6
Darsidomine
114030-44-3
Dexpemedolac
115464-77-2
Elopiprazole
141790-23-0
Fozivudine tidoxil
122254-45-9
Glenvastatin
143443-90-7
Ifetroban
82857-82-7
Ilepcimide
104454-71-9
Ipenoxazone
118288-08-7
Lafutidine
138068-37-8
Lepirudin
78994-23-7
Levormeloxifene
116476-16-5
Levosemotiadil
148152-63-0
Napitane
84558-93-0
Netivudine
147432-77-7
Ontazolast
139225-22-2
Panamesine
103255-66-9
Pazinaclone
123447-62-1
Prulifloxacin
131986-45-3
Xanomeline
145781-32-4
Zolasartan
2935 00 90
147536-97-8
Bosentan
136817-59-9
Delavirdine
119905-05-4
Delequamine
112966-96-8
Domitroban
125279-79-0
Ersentilide
139133-26-9
Lexipafant
154397-77-0
Napsagatran
139133-27-0
Nupafant
116649-85-5
Ramatroban
133276-80-9
Samixogrel
146623-69-0
Saprisartan
149556-49-0
Susalimod
144494-65-5
Tirofiban
139308-65-9
Tolafentrine
107753-78-6
Zafirlukast
2936 29 90
131875-08-6
Lexacalcitol
2937 10 10
9002-68-0
Follitropin alfa
152923-57-4
Lutropin alfa
2937 22 00
103466-73-5
Icometasone enbutate
2937 29 90
144459-70-1
Rofleponide
2937 99 00
124478-60-0
Aglepristone
140703-51-1
Examorelin
133107-64-9
Insulin lispro
144743-92-0
Teverelix
2939 50 90
151581-23-6
Apaxifylline
132210-43-6
Cipamfylline
100324-81-0
Lisofylline
98833-92-2
Stacofylline
2939 90 90
135905-89-4
Mirisetron
117086-68-7
Ricasetron
25775-90-0
Zucapsaicin
2940 00 90
133692-55-4
Seprilose
2941 90 00
127785-64-2
Basifungin
116853-25-9
Cefluprenam
122841-10-5
Cefoselis
156131-91-8
Dimadectin
123997-26-2
Eprinomectin
149951-16-6
Lenapenem
108852-90-0
Nemorubicin
159445-62-2
Orientiparcin
156769-21-0
Sanfetrinem
3001 90 99
120993-53-5
Desirudin
3002 10 91
143653-53-6
Abciximab
156227-98-4
Afelimomab
151763-64-3
Capromab
152923-56-3
Dacliximab
145832-33-3
Detumomab
142864-19-5
Enlimomab
152981-31-2
Inolimomab
150631-27-9
Nacolomab tafenatox
159445-64-4
Odulimomab
147191-91-1
Priliximab
153101-26-9
Regavirumab
148189-70-2
Votumumab
3002 10 95
143090-92-0
Anakinra
143631-61-2
Atexakin alfa
148637-05-2
Cilmostim
154725-65-2
Epoetin epsilon
148363-16-0
Epoetin omega
102786-52-7
Eptacog alfa (activated)
156679-34-4
Lenercept
124146-64-1
Mobenakin
0-00-0
Moroctocog alfa
148641-02-5
Muplestim
139076-62-3
Octocog alfa
3003 39 00
0-00-0
Plusonermin
3003 90 90
0-00-0
Fuladectin
3507 90 90
143831-71-4
Dornase alfa
154248-97-2
Imiglucerase
149394-67-2
Ledimase
156616-23-8
Monteplase
159445-63-3
Nateplase
155773-57-2
Pegorgotein
3911 90 19
95522-45-5
Colestilan
31512-74-0
Polixetonium chloride
3913 90 80
39464-87-4
Betasizofiran
0-00-0
Certoparin sodium
0-00-0
Minolteparin sodium
ANNEX II
Additional pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to receive duty-free treatment
CN code
CAS RN
Name
2843 30 00
12192-57-3
(alpha-D-glucopyranosylthio) gold
2903 69 90
42074-68-0
1-chloro-2-(chlorodiphenylmethyl) benzene
76283-09-5
alpha,4-dibromo-2-fluorotoluene
2906 29 90
104265-58-9
2-[(1 S,2R)-6-fluoro-2-hydroxy-1 -isopropyl-1,2,3,4-tetrahydro-2-naphthyl] ethyl p-toluenesulfonate
2907 29 90
700-13-0
2,3,5-tximethylhydroquinone
2909 50 90
63659-16-5
4-[2-(cyclopropylmethoxy) ethyl] phenol
2914 40 90
80-75-1
11-alpha-hydroxypregn-4-ene-3,20-dione
2914 50 00
2107-69-9
5,6-dimethoxyindan-1 -one
24916-90-3
9-beta,11-beta-epoxy-17,21-dihydroxy-l6-alpha-methylpregna-l,4-diene-3,20-dione
2914 70 90
83881-08-7
21-chloro-9-beta, 11 -beta-epoxy-17-hydroxy-16-alpha-methylpregna-1,4-diene-3,20-dione
2915 39 90
979-02-2
20-oxopregna-5,l 6-dien-3-beta-yl acetate
2915 90 20
638-41-5
pentyl chloroformate
2916 39 00
49708-81-8
trans-4-(p-chlorophenyl)cyclohexanecarboxylic acid
2917 19 90
48059-97-8
(E)-oct-4-ene-1,8-dioic acid
71170-82-6
triethyl 3-bromopropane-1,1,1-tricarboxylate
2917 39 80
27932-00-9
indan-5-yl hydrogen phenylmalonate
2918 13 00
2743-38-6
dibenzoyl-L-tartaric acid
2918 17 00
4358-88-7
ethyl DL-mandelate
2918 19 80
56188-04-6
{(1 R,3R,5S)-3,5-dihydroxy-2-[(E)-(3S)-3-hydroxyoct-1 -enyl]cyclopentyl}acetic acid
2918 29 90
167678-46-8
3-chloroformyl-o-tolyl acetate
2918 30 00
56105-81-8
(R)-2-(3-benzoylphenyl) propionic acid
22161-86-0
(RS)-2-(3-benzoylphenyl) propionic acid
78834-75-0
enthyl 7-chloro-2-oxoheptanoate
1944-63-4
3-[(3aS,4S,7aS)-7a-methyl-1,5-dioxooctahydro-1 H-inden-4-yl]propionic acid
39562-17-9
methyl 2-(3-nitrobenzylidene)-3-oxobutyrate
2918 90 90
26159-31-9
(RS)-2-(6-methoxy-2-naphthyl)propionic acid
105560-93-8
methyl (2R,3S)-2,3-epoxy-3-(4-methoxyphenyl) propionate
40098-26-8
methyl 7-[(3RS)-3-hydroxy-5-oxocyclopent-1-enyl]heptanoate
2921 19 80
4261-68-1
(2-chloroethyl) diisopropylamine hydrochloride
2921 59 90
122-75-8
N, N'-dibenzylethylenediammonium di (acetate)
2922 19 00
126456-43-7
(1S,2R)-1-aminoindan-2-ol
68047-07-4
4'-[2-(dimethylamino) ethoxy]-2-phenylbutyrophenone
2922 30 00
784-38-3
2-amino-5-chloro-2'-fluorobenzophenone
156732-13-7
(S)-5-amino-2-(dibenzylamino)-1,6-diphenylhex-4-en-3-one
2922 49 70
37441-29-5
5-amino-2,4,6-triiodoisophthaloyl dichloride
42854-62-6
benzyl L-alaninate--p-toluenesulfonic acid (1:1)
39878-87-0
(-)-alpha-(chloroformyl) benzylammonium chloride
54527-73-0
2-(N-methylbenzylamino) ethyl 3-aminobut-2-enoate
81677-60-3
methyl (4-nitrophenyl)-L-alaninate
949-99-5
3-(4-nitrophenyl)-L-alanine
2924 10 00
153758-31-7
(2S)-2-amino-3-hydroxy-N-pentylpropionamide--oxalic acid (1:1)
138531-07-4
L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-o
L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysine
2924 29 90
40188-45-2
3'-acetyl-4'-hydroxybutyranilide
1149-26-4
N-(benzyloxycarbonyl)-L-valine
116661-86-0
(2S,3S)-3-(tert-butoxycarbonylamino)-2-hydroxy-4-phenylbutyric acid
144163-85-9
tert-butyl [(1S,3S,4S)-4-amino-1-benzyl-3-hydroxy-5-phenylpentyl] carbamate
149451-80-9
tert-butyl [(1S,2S)-1-benzyl-2,3-dihydroxypropyl] carbamate
98737-29-2
tert-butyl {(S)-alpha-[(S)-oxiranyl]phenethyl}carbamate
0-00-0
2-chloro-N-[2-(2-chlorobenzoyl)-4-nitrophenyl] acetamide
125971-96-2
2-[alpha-(4-fluorobenzoyl)benzyl]-4-methyl-3-oxovaleranilide
32981-85-4
methyl (2R,3S)-3-benzamido-2-hydroxy-3-phenylpropionate
2925 19 80
151860-15-0
meso-N-benzyl-3-nitrocyclopropane-1,2-dicarboximide
97338-03-9
ethyl (S)-3-(4-aminopheynl)-2-phthalimidopropionate hydrochloride
94213-26-0
ethyl (S)-3-{4-[bis(2-chloroethyl)amino]phenyl}-2-phthalimidopropionate hydrochloride
2926 90 80
58311-73-2
(Z)-(2-cyanovinyl)trimethylammonium p-toluenesulfonate
133481-10-4
ethyl (l-cyanocyclohexl)acetate
123632-23-5
4-(2,2,3,3-tetrafluoropropoxy)cinnamonitrile
2928 00 90
94213-23-7
(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine
2930 90 16
159453-24-4
N-(benzyloxycarbonyl)-S-phenyl-L-cysteine
2930 90 70
159878-02-1
benzyl (1 R,2S)-3-chloro-2-hydroxy-1 -(phenylthiomethyl)propylcarbamate
136511-43-8
ethyl N-{2-[(acetylthio)methyl]-3-(o-tolyl)-1-oxopropyl}-L-methionate
2932 19 00
97148-39-5
ammonium (Z)-2-methoxyimino-2-(2-furyl)acetate
2932 29 80
517-23-7
alpha-acetyl-gamma-butyrolactone
6559-91-7
4'-demethylepipodophyllotoxin
39521-49-8
(3aR,4bS,4R,4aS,5aS)-4-(5,5-dimethyl-1,3-dioxolan-2-yl)hexahydrocyclopropa[3,4]cyclopenta[l,2-b]furan-o 2(3H)-one
39746-01-5
(3aR,4R,5R,6aS)-4-formyl-2-oxohexahydro-2H-cyclopenta[b]furan-5-yl benzoate
976-70-5
3-oxopregn-4-ene-21,17-alpha-carbolactone
2932 99 50
32981-86-5
10-deacetylbaccatin III
2932 99 70
7512-17-6
2-acetamido-2-deoxy-beta-D-glucopyranose
79944-37-9
trans-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
125971-94-0
tert-butyl [(4R,6R)-6-(cyanomethyl)-2,2-dimethyl-1,3-dioxolan-4-yl]acetate
467-55-0
3-beta-hydroxy-5-alpha-spirostan-12-one
533-31-3
3,4-(methylenedioxy)phenol
2933 11 90
6150-97-6
magnesium bis [(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1 H-pyrazol-4-yl)methylamino]methane- sulfonate
2933 19 90
27511-79-1
3-aminopyrazole-4-carboxamide hemisulfate
2933 29 90
4897-25-0
5-chloro-1-methyl-4-nitroimidazole
2933 39 95
142057-79-2
(RS)-2[(1 -benzyl-4-piperidyl)methyl]-5,6-dimethoxyindan-l -one
120014-07-5
2-[(l-benzyl-4-piperidyl)methylene]-5,6-dimethoxyindan-1-one
6935-27-9
benzyl(2-pyridy l)amine
87848-95-1
6-bromo-2-pyridyl-p-tolyl ketone
32998-95-1
N-(tert-butyl)-3-methylpyridine-2-carboxamide
84449-80-9
1-[2-(4-carboxyphenoxy)ethyl]piperidinium chloride
83949-32-0
4-carboxy-4-phenylpiperidinium p-toluenesulfonate
38092-89-6
8-chloro-6,11-dihydro-11-(l-methyl-4-piperidylidene)-5H-benzo[5,6]cyclohepta[l,2-b]pyridine
31255-57-9
3-[2-(3-chlorophenyl)ethyl]pyridine-2-carbonitrile
107256-31-5
3-[2-(3-chlorophenyl)ethyl]-2-pyridyl 1 -methyl-4-piperidyl ketone hydrochloride
6298-19-7
2-chloro-3-pyridylamine
5424-11-3
2,2-diphenyl-4-piperidinovaleronitrile
108555-25-5
1-[2-(4-methoxyphenyl)ethyl]-4-piperidylamine dihydrochloride
4046-24-6
5-(l -methyl-4-piperidyl)-5H-dibenzo[a,d]cyclohepten-5-ol hydrochloride
139886-04-7
1-methyl-1,2,5,6-tetrahydropyridine-3-carbaldehyde (E)-O-methyloxime hydrochloride
70708-28-0
1-(2-pyridyl)-3-(pyrrolidin-1-yl)-1-(p-tolyl)propan-1-ol
1619-34-7
quinuclidin-3-ol
2933 40 10
105956-96-5
7-[3-(tert-butoxycarbonylamino)pyrrolidin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroc quinoline-3-carboxylic acid
86393-33-1
7-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
112811-72-0
1-cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
98349-25-8
ethyl 1 -cyclopropyl-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate
2933 40 90
159878-04-3
benzyl (1S,2S)-3-[3S,4aS,8aS)-3-tert-butylcarbamoylperhydro-2-isoquinolyl]-2-hydroxy-1-(phenylthioc methyl)propylcarbamate
159989-64-7
(3S,4aS,8aS)-N-(tert-butyl)-2-[(2S,3S)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylthio)butyl] perhydroisoquinoline-3-carboxamide
159989-65-8
(3S,4aS,8aS)-N-(tert-butyl)-2-[(2S,3S)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylthio)butyl] perhydroisoquinoline-3-carboxamide—methanesulfonic acid (1:1)
120578-03-2
3-[(E)-2-(7-chloro-2-quinolyl)vinyl]benzaldehyde
1087-69-0
(9S,13S,14S)-3-methoxymorphinan hydrochloride
64228-78-0
pentamethylene bis {3-[10-(3,4-dimethoxybenzyl)-6,7-dimethoxy-1,2,3,4-tetrahydro-2-isoquinolyl] propionate]- -oxalic acid (1:2)
2933 59 70
75128-73-3
2-[(2-acetamido-6-oxo-6,9-dihydro-1H-purin-9-yl)methoxy]ethyl acetate
3056-33-5
N-(9-acetyl-6-oxo-6,9-dihydro-1H-purin-2-yl)acetamide
10310-21-1
2-amino-6-chloropurine
124832-31-1
2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl N-(benzyloxycarbonyl)-L-valinate
150378-17-9
(2R,4S)-2-benzyl-5-[2-(tert-butylcarbamoyl)-4-(3-pyridylmethyl)piperazin-1-yl]-4-hydroxy-N-[(1S,2R)-2-hydroxyindan-1-yl]valeramide
157810-81-6
(2R,4S)-2-benzyl-5-[2-(tert-butylcarbamoyl)-4-(3-pyridylmethyl)piperazin-1-yl]-4-hydroxy-N-[(lS,2R)-c 2-hydroxyindan-1-yl]valeramide sulfate
150323-35-6
(3S)-1-(tert-butoxycarbonyl)-3-(tert-butylcarbamoyl)piperazine
41202-32-8
1-(2-chlorophenyl)piperazine hydrochloride
13078-15-4
1-(3-chlorophenyl)piperazine hydrochloride
71-30-7
cytosine
149062-75-9
1,3-dichloro-6,7,8,9,1 0,1 2-hexahydroazepino[2,1 -b]quinazoline hydrochloride
41202-77-1
1-(2,3-dichlorophenyl)piperazine hydrochloride
56177-80-1
2-ethoxy-5-fluoropyrimidin-4(1 H)-one
112733-45-6
ethyl (7-chloro-2,4-dioxo-1,2,3,4-tetrahydroquinazolin-l -yl)acetate
59703-00-3
4-ethyl-2,3-dioxopiperazine-l-carbonyl chloride
64090-19-3
1-(4-fluorophenyl)piperazine dihydrochloride
147539-21-7
isopropyl[2-(piperazin-1-yl)-3-pyridyl]amine
35386-24-4
1-(2-methoxyphenyl)piperazine
5464-78-8
1-(2-methoxyphenyl)piperazine hydrochloride
145012-50-6
(7RS,9aRS)-perhydropyrido[l,2-a]pyrazin-7-ylmethanol
2210-93-7
1-phenylpiperazinium chloride
111641-17-9
4-(piperazin-1-yl)-2,6-bis(pyrrolidin-1-yl)pyrimidine
68-94-0
purin-6(1 H)-one
70849-60-4
1-(o-tolyl)piperazine hydrochloride
2933 69 80
58909-39-0
tetrahydro-2-methyl-3-thioxo-1,2,4-triazine-5,6-dione
2933 79 00
135297-22-2
(3S,4R)-3-[(R)-1-(tert-butyldimethylsilyloxy)ethyl]-4-[(lR,3S)-3-methoxy-2-oxocyclohexyl]azetidin-2-one
141646-08-4
1-|[(cyclohexyloxy)carbonyl]oxy}ethyl 1 -(1 -hydroxyethyl)-5-methoxy-2-oxo-1,2,5,6,7,8,8 a,8b-octahydroazeto*c [2,1 -a]isoindole-4-carboxylate
132127-34-5
(3R,4S)-3-hydroxy-4-phenylazetidin-2-one
75363-99-4
p-nitrobenzyl (2R,5R,6S)-6-[(R)-1-hydroxyethyl]-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate
141316-45-2
potassium 1 -(1 -hydroxyethyl)-5-methoxy-2-oxo-1,2,5,6,7,8,8 a,8b-octahydroazeto[2,1 -a]isoindole-4-carbc oxylate
2933 90 60
59467-64-0
[7-chloro-5-(2-fluorophenyl)-2,3-dihydro-1H-1,4-benzodiazepin-2-yl]methylamine
59469-29-3
[7-chloro-5-(2-fluorophenyl)-2,3-dihydro-1 H-l,4-benzodiazepin-2-ylmethyl]ammonium bis(maleate)
59467-69-5
8-chloro-6-(2-fluorophenyl)-1-methyl-3a,4-dihydro-3H-imidazo[l,5-a][l,4]benzodiazepine
59469-63-5
7-chloro-5-(2-fluorophenyl)-3-methyl-2-(nitromethylene)-2,3-dihydro-1 H-1,4-benzodiazepine 4-oxide
59467-63-9
7-chloro-5-(2-fluorophenyl)-2(nitromethylene)-2,3-dihydro-1 H-1,4-benzodiazepine
2933 90 95
130404-91-0
N-[(R)-2-({(R)-2-[(2-adamantyloxycarbonyl)amino]-3-(lH-indol-3-yl)-2-methyl-1-oxopropyl}amino)-1- phenylethyl]succinamic acid-1-deoxy-1-methylamino-D-glucitol (1:1)
122536-48-5
3-[(S)-3-(L-alanylamino)pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3- carboxylic acid hydrochloride
122536-91-8
7-{(S)-3-[(S)-2-(tert-butoxycarbonylamino)-1-oxopropylamino]pyrrolidin-1-yl}-1-cyclopropyl-6-fluoro-4- oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
134575-17-0
tert-butyl meso-3-azabicyclo[3.1.0]hex-6-ylcarbamate
122536-66-7
tert-butyl [(S)-1-methyl-2-oxo-2-[(S)-pyrrolidin-3-ylamino]ethyl}carbamate
140629-77-2
tert-butyl [(RS)-pyrrolidin-3-yl] carbamate
100361-18-0
7-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
38150-27-5
5-chloro-2-[3-(hydroxymethyl)-5-methyl-4H-1,2,4-triazol-4-yl]ben2Ophenone
36916-19-5
5-chloro-2-(3-methyl-4H-1,2,4-triazol-4-yl)benzophenone
54196-62-2
2',5-dichloro-2-[3-(hydroxymethyl)-5-methyl-4H-1,2,4-triazol-4-yl]benzophenone
54196-61-1
2',5-dichloro-2-(3-methyl-4H-1,2,4-triazol-4-yl)benzophenone
141113-28-2
(E)-( + )-2-(2,4-difluorophenyl)-1 -[3-[4-(2,2,3,3-tetrafluoropropoxy)styryl]-1 H-1,2,4-triazol-1 -yl}-3-(1 H- 1,2,4-triazol-1-yl)propan-2-ol
141113-41-9
(R)-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1 -yl)propane-1,2-diol
144034-80-0
dimethyl{2-[5-(1 H-1,2,4-triazol-1-ylmethyl)indol-3-yl]ethyl}amine
122665-86-5
ethyl [3-(cyanomethyl)-4-oxo-3,4-dihydrophthalazin-1 -yl]acetate
41340-36-7
2-(7-ethyl-lH-indol-3-yl)ethanol
95885-13-5
5-ethyl-4-(2-phenoxyethyl)-4H-1,2,4-triazol-3(2H)-one
96107-94-7
ethyl 1 H-tetrazole-5-carboxylate, sodium salt
96034-57-0
trans-4-hydroxy-1-(4-nitrobenzyloxycarbonyl)-L-proline
160194-26-3
2-iodo-4-(1 H-1,2,4-triazol-1-ylmethyl)aniline
66635-71-0
isopropyl 2,3-dihydro-1 H-pyrrolizine-1-carboxylate
4928-88-5
methyl 1 H-1,2,4-triazole-3-carboxylate
0-00-0
1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid sulfate
112193-77-8
1,4,7,10-tetraazoniacyclododecane bis(sulfate)
3641-08-5
1 H-l,2,4-triazole-3-carboxamide
4928-87-4
1 H-1,2,4-triazole-3-carboxylic acid
6969-71-7
1,2,4-triazolo[4,3-a]pyridin-3(2H)-one
2934 10 00
171485-87-3
2-[4-(2-amino-4-oxo-4,5-dihydrothiazol-5-ylmethyl)phenoxymethyl]-2,5,7,8-tetramethylchroman-6-yl acetate
65872-41-5
(Z)-2-(2-aminothiazol-4-yl)-2-methoxyiminoacetic acid
64486-18-6
(Z)-2-[2-(chloroacetamido)thiazol-4-yl]-2-(methoxyimino) acetic acid
76823-93-3
1-{4-[(2-cyanoethyl)thiomethyl]thiazol-2-yl}guanidine
139340-56-0
[5-[(Z)-3,5-di(tert-butyl)-4-hydroxybenzylidene]-4-oxo-4,5-dihydrothiazol-2-yl]ammonium methanec sulfonate
64485-88-7
ethyl (Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino) acetate
66339-00-2
ethyl 2-(hydroxyimino)-2-[2-(tritylamino)thiazol-4-yl]acetate hydrochloride
88046-01-9
2-guanidinothiazol-4-ylmethyl carbamimidothioate dihydrochloride
154212-61-0
N-[2-isopropylthiazol-4-ylmethyl(methyl)carbamoyl]-L-valine
66215-71-2
(Z)-2-methoxyimino-2-[2-(tritylamino)thiazol-4-yl] acetic acid
154212-59-6
4-nitrophenyl thiazol-5-ylmethyl carbonate hydrochloride
38585-74-9
thiazol-5-ylmethanol
155213-67-5
thiazol-5-ylmethyl (lS,2S,4S)-1-benzyl-2-hydroxy-4-{(2S)-2-[3-(2-isopropylthiazol-4-ylmethyl)-3-methyl ureido]-3-methylbutyramido}-5-phenylpentylcarbamate
2934 20 50
80756-85-0
S-(benzothiazol-2-yl) (Z)-2-(2-aminothiazol-4-yl)-2-methoxyiminothioacetate
2934 20 90
87691-88-1
1-(1,2-benzisothiazol-3-yl)piperazine hydrochloride
2934 90 50
111974-69-7
2-{2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy}ethanol
42399-49-5
(2S,3S)-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5-benzothiazepin-4(5H)-one
2934 90 60
115787-67-2
2-(2-amino-5-nitro-6-oxo-1,6-dihydropyrimidin-4-yl)-3-(3-thienyl)propiononitrile
117829-20-6
2-amino-7-thenyl-1,7-dihydro-4H-pyrrolo[2,3-d]pyrimidin-4-one hydrochloride
112887-68-0
N-{5-[(1,4-dihydro-2-methyl-4-oxoquinazolin-6-ylmethyl)methylamino]-2-thenoyl}-L-glutamic acid
161005-84-1
(S)-N,N-dimethyl-[3-(2-thienyl)-3-(1-naphthyloxy)propyl]amine-phosphoric acid (1:1)
104795-66-6
3-isopropoxy-5-methoxy-N-(1H-tetrazol-5-yl)benzo[b]thiophene-2-carboxamide
104795-67-7
3-isopropoxy-5-methoxy-N-(1H-tetrazoI-5-yl)benzo[b]thiophene-2-carboxamide-1H-imidazole (1:1)
104795-68-8
3-isopropoxy-5-methoxy-N-(1H-tetrazol-5-yl)benzo[b]thiophene-2-carboxamide, sodium salt
63675-74-1
6-methoxy-2-(4-methoxyphenyl)benzo[b]thiophene
138564-59-7
5-methyl-2-(2-nitroanilino)thiophene-3-carbonitrile
2934 90 70
25229-97-4
2-cyano-3-morpholinoacrylamide
2934 90 80
119221-49-7
5-[(2-aminoethyl)amino]-2-(2-diethylaminoethyl)-2H-[1]benzothiopyrano[4,3,2-cd]indazol-8-ol
147086-81-5
(4S,6S)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-4-ol 7,7-dioxide
2934 90 98
58-61-7
adenosine
152305-23-2
(S)-4-(4-aminobenzyl)oxazolidin-2-one
71420-85-4
7-amino-3-[1-(sulfomethyl)-1H-tetrazol-5-ylthiomethyl]-3-cephem-4-carboxylic acid, sodium salt
29706-84-1
3'-azido-3'-deoxy-5'-0-tritylthymidine
51762-51-7
benzhydryl 3-hydroxy-7-(phenylacetamido)cepham-4-carboxylate
110314-42-6
5-[(benzofuran-2-ylcarbonyl)amino]indole-2-carboxylic acid
131986-28-2
3-(4-chloro-1,2,5-thiadiazol-3-yl)pyridine
107452-89-1
omega-conotoxin M VIIA
126429-09-2
2-(dichloromethyl)-4,5-dihydro-5-(4-mesylphenyl)oxazol-4-ylmethanol
126813-11-4
(4R,5R)-2-(dichloromethyl)-4,5-dihydro-5-(4-mesylphenyl)oxazol-4-ylmethanol
4097-22-7
2',3'-dideoxyadenosine
139264-17-8
(S)-4-{[3-(2-dimethylaminoethyl)-1H-indol-5-yI]methyl}oxazolidin-2-one
110351-94-5
(S)-4-ethyl-4-hydroxy-7,8-dihydro-1H-pyrano[3,4-f]indolizine-3,6,10(4H)-trione
140841-32-3
6-[3-fluoro-5-(4-methoxytetrahydropyran-4-yl)phenoxymethyl]-1-methyl-2-quinolone
94732-98-6
1-(1-{3-[2-(4-fluorophenyl)-1,3-dioxolan-2-yl]propyl}-4-piperidyl)-2,3-dihydro-1H-benzimidazole-2-thione
125995-03-1
(4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]ethyl}-4-hydroxy tetrahydro-2H-pyran-2-one
131988-19-7
3-(4-hexyloxy-1,2,5-thiadiazol-3-yl)-1-methylpyridinium iodide
147027-10-9
(1R,2S,5R)-menthyl (2R,5S)-5-(4-amino-2-oxo-1,2-dihydropyrimidin-1-yl)-1,3-oxathiolane-2-carboxylate
147126-62-3
(1R,2S,5R)-menthyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
104218-44-2
3'-O-mesyl-5'-O-tritylthymidine
27255-72-7
3-methyl-7-(phenylacetamido)-3-cephem-4-carboxylic acid
0-00-0
(1R,2S,3S,6R)-[(S)-1-phenylethyl]-3,6-epoxytetrahydrophthalimide
32231-06-4
1-piperonylpiperazine
55612-11-8
5'-O-tritylthymidine
2935 00 90
151140-66-8
(4-amino-3-iodophenyl)-N-methylmethanesulfonamide
112101-81-2
5-[(R)-(2-aminopropyl)]-2-methoxybenzenesulfonamide
120298-38-6
N-(5,6-dihydro-6-methyl-2-sulfamoyl-4H-thieno[2,3-b]thiopyran-4-yl)acetamide 7,7-dioxide
150975-95-4
5-methanesulfonamidoindole-2-carboxylic acid
84522-34-9
sodium 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzenesulfonamide
2939 10 00
66820-84-6
(RS)-tetrahydropapaverine hydrochloride
2940 00 90
13035-61-5
1,2,3,5-tetraacetyl-beta-D-ribofuranose
3824 90 64
330-95-0
1,3-bis(4-nitrophenyl)urea--4,6-dimethylpyrimidin-2-ol (1:1)
104832-01-1
(R)-6,7-dimethoxy-2-methyl-1-(3,4,5-trimethoxybenzyl)-1,2,3,4-tetrahydroisoquinoline~dibenzoyl-L-tartaric acid (1:1)
0-00-0
Intermediate concentrate obtained from a genetically-modified Escherichia coli fermentation medium, containing human granulocyte-macrophage colony-stimulating factor; for use in the manufacture of medicaments of HS No 30.02
0-00-0
Intermediate concentrate obtained from a genetically-modified Escherichia coli fermentation medium, containing human interferon alpha-2b; for use in the manufacture of medicaments of HS No 30.02
0-00-0
Intermediate concentrates obtained from a Micromonospora inyoensis fermentation medium used for the manufacture of the antibiotics sisomicin (INN) and netilmicin (INN)
0-00-0
Intermediate concentrates obtained from a Micromonospora purpurea fermentation medium used for the manufacture of the antibiotics gentamicin sulfate (INNM) and isepamicin (INN)
3824 90 95
0-00-0
ethyl 7-chloro-2-oxoheptanoate, in the form of a solution in toluene
3911 90
162430-94-6
1,6-hexanediamine, polymer with 1,10-dibromodecane
3913 90 80
83513-48-8
danaparoid sodium
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-l-carboxylate
mofetil
octil
olamine
oxoglurate
pendetide
pivoxetil
proxetil
l-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
CN code
CAS RN
Name
2903 22 00
79-01-6
trichloroethylene
2903 30 10
811-97-2
norflurane
2903 51 10
58-89-9
lindane
2906 21 00
100-51-6
benzyl alcohol
2915 29 00
82279-57-0
zinc acetate, basic
2922 41 00
56-87-1
lysine
2922 42 90
56-86-0
glutamic acid
2922 49 10
56-40-6
glycine
2922 50 00
72-19-5
threonine
2923 10 10
67-48-1
choline chloride
2928 00 90
79-17-4
pimagedine
2930 90 20
111-48-8
thiodiglycol
2933 90 95
73-22-3
tryptophan
3102 70 10
156-62-7
calcium carbimide
3904 61 10
9002-84-0
politef
3906 90 90
54182-57-9
carbomer
3907 20
0-00-0
macrogol ester
3907 20 12
25322-68-3
macrogol
3907 20 21
25301-02-4
tyloxapol
3907 60 10
25038-59-9
pegoterate
3908 10 00
25038-54-4
policapram
3910 00 00
9006-65-9
dimeticone
3912 20 11
9004-70-0
pyroxylin
3912 31 00
9000-11-7
carmellose
3912 39 80
8063-82-9
hypromellose

Summary:
Duty-free treatment of specified pharmaceutical active ingredients
Duty-free treatment of specified pharmaceutical active ingredients
SUMMARY OF:
Regulation (EU) No 1238/2010 – duty-free treatment of specified pharmaceutical active ingredients and products in finished pharmaceuticals
Regulation (EC) No 467/97 – duty-free treatment of specified ingredients and products used in finished pharmaceuticals and withdrawing this treatment for others
WHAT IS THE AIM OF THE REGULATIONS?
The regulations incorporate into European Union (EU) law duty-free decisions for certain pharmaceuticals and active ingredients. These were first taken in the Uruguay Round of international trade negotiations.
The items each have an international nonproprietary name (INN)* and new ones have been added to the lists on several occasions.
Regulation (EU) No 1238/2010 updates the lists after the fourth review launched in 2009.
Council Regulation (EC) No 467/97 updates the lists after the first review.
KEY POINTS
Regulation (EU) No 1238/2010
It amends Annex I (lists of pharmaceutical substances qualifying for duty-free treatment) to Regulation (EEC) No 2658/87 setting out the EU’s combined nomenclature.
It gives duty-free treatment from 1 January 2011 to: products with a World Health Organization international non-proprietary name (Annex I);the list of prefixes and suffixes which, combined with INNs, describe their salts, esters or hydrates which are also eligible for duty-free treatment (Annex II);pharmaceutical intermediates used to produce and manufacture finished pharmaceuticals (Annex III).
It removes certain pharmaceutical intermediates from the list of those receiving duty-free treatment (Annex IV).
Regulation (EC) No 467/97
It gives duty-free treatment from 1 April 1997 to: 231 designated pharmaceutical active ingredients with an INN, along with their salts, esters and hydrates (Annex I);234 designated products used to produce and manufacture finished pharmaceuticals (Annex II).
It expands the list of specified prefixes and suffixes of INNs eligible by adding 84 names to duty-free treatment (Annex III).
It removes 25 products – together with their salts, esters and hydrates – from duty-free treatment since their use was predominantly non-pharmaceutical (Annex IV).
FROM WHEN DO THE REGULATIONS APPLY?
Regulation (EU) No 1238/2010 has applied since 1 January 2011.
Regulation (EC) No 467/97 has applied since 14 March 1997.
BACKGROUND
During the Uruguay Round, the most important producers – the EU, the United States, Japan, Canada, Switzerland, Norway and China – agreed to reduce duties on pharmaceuticals to zero. The agreement covered over 6,000 products.
With the development of new drugs, reviews took place in 1995–1996, 1998 and 2006, adding almost 2,400 products. The fourth review added 718 new substances, bringing the total of duty-free pharmaceutical imports into the EU to 8,619.
For further information, see: International nonproprietary names programme and classification of medical products (World Health Organization).
KEY TERMS
              
International nonproprietary names (INN). Also known as generic names, they identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and that is classified as public property. The World Health Organization works closely with INN experts and national nomenclature committees to select a single name that is accepted worldwide for each active substance to be marketed as a pharmaceutical.
MAIN DOCUMENTS
            
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 (OJ L 348, 31.12.2010, pp. 36–73).
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 (OJ L 71, 13.3.1997, pp. 1–15).
RELATED DOCUMENTS
            
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, pp. 1–675).
Successive amendments to Regulation (EEC) No 2658/87 have been incorporated in the original text. This consolidated version is of documentary value only.
last update 14.12.2021