Lexploria

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