http://www.legislation.gov.uk/eur/1997/467Council 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 pharmaceuticalCouncil regulation (EC) No 467/97Council 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 pharmaceutical2020-12-12King's Printer of Acts of 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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 <VALUE>CELEX1</VALUE> 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 codeCAS RNName
2844 40 30113716-48-6Iolopride (123 I)
142481-95-6Technetium (99m Tc) furifosmin
2846 90 00131069-91-5Gadoversetamide
135326-11-3Gadoxetic acid
138721-73-0Sprodiamide
2914 40 9020098-14-0Idramantone
2916 39 0071109-09-6Vedaprofen
2918 30 0022161-81-5Dexketoprofen
112665-43-7Seratrodast
2918 90 90139403-31-9Pimilprost
2921 49 90136236-51-6Rasagiline
2922 49 706582-31-6Dapabutan
2923 90 001794-75-8Laurcetium bromide
2924 10 001675-66-7Adelmidrol
62304-98-7Thymalfasin
132787-19-0Tradecamide
129009-83-2Versetamide
2924 29 90147362-57-0Loviride
94497-51-5Tamibarotene
2925 19 80144849-63-8Bisnafide
2925 20 00137159-92-3Aptiganel
2926 90 80137109-71-8Balazipone
147076-36-6Laflunimus
2928 00 90141579-54-6Fenleuton
2930 90 1687573-01-1Salnacedin
2930 90 7090357-06-5Bicalutamide
112573-72-5Dexecadotril
107023-41-6Pobilukast
81110-73-8Racecadotril
2931 00 50132236-18-1Zifrosilone
2931 00 80114084-78-5Ibandronic acid
124351-85-5Incadronic acid
63132-39-8Olpadronic acid
2932 99 70105674-77-9Lanproston
2932 99 90123407-36-3Arteflene
132017-01-7Bervastatin
110816-79-0Cromoglicate lisetil
149494-37-1Ebalzotan
151581-24-7Iralukast
113806-05-6Olopatadine
139110-80-8Zanamivir
2933 29 90158682-68-9Elisartan
116684-92-5Galdansetron
89371-44-8Imidaprilat
138402-11-6Irbesartan
118072-93-8Zoledronic acid
2933 39 95119257-34-0Besipirdine
118248-91-2Fodipir
155415-08-0Inogatran
121750-57-0Itameline
144412-49-7Lamifiban
155319-91-8Mangafodipir
150443-71-3Nicanartine
29876-14-0Nicotredole
144035-83-6Piclamilast
137795-35-8Spiroglumide
147025-53-4Talsaclidine
149488-17-5Trovirdine
2933 40 10127294-70-6Balofloxacin
143383-65-7Premafloxacin
143224-34-4Telinavir
2933 40 9096946-42-8Cisatracurium besilate
158966-92-8Montelukast
136668-42-3Quiflapon
2933 59 70127266-56-2Adatanserin
106941-25-7Adefovir
113852-37-2Cidofovir
150756-35-7Efletirizine
119687-33-1Iganidipine
127759-89-1Lobucavir
140945-32-0Mapinastine
134208-17-6Mazapertine
96604-21-6Ocinaplon
148504-51-2Ripisartan
115762-17-9Ruzadolane
118420-47-6Tagorizine
137234-62-9Voriconazole
151319-34-5Zaleplon
2933 79 00148396-36-5Fradafiban
74436-00-3Geclosporin
143943-73-1Lirequinil
106730-54-5Olprinone
135548-15-1Oxeclosporin
145733-36-4Tasosartan
143343-83-3Toborinone
2933 90 95137882-98-5Abitesartan
114607-46-4Acitazanolast
120511-73-1Anastrozole
134523-00-5Atorvastatin
128270-60-0Bivalirudin
139481-59-7Candesartan
54278-85-2Candocuronium iodide
105806-65-3Efegatran
62568-57-4Emideltide
120081-14-3Goralatide
142880-36-2Ilornastat
62732-44-9Ipidacrine
116287-14-0Lanperisone
112809-51-5Letrozole
116644-53-2Mibefradil
136122-46-8Mipitroban
144702-17-0Pomisartan
132036-88-5Ramosetron
106308-44-5Rufinamide
144701-48-4Telmisartan
147059-72-1Trovafloxacin
2934 10 00149079-51-6Cartasteine
128312-51-6Cinalukast
51287-57-1Denotivir
101001-34-7Pamicogrel
136433-51-7Tazofelone
138742-43-5Zankiren
2934 20 90144665-07-6Lubeluzole
150915-41-6Perospirone
146939-27-7Ziprasidone
2934 90 60130370-60-4Batimastat
133040-01-4Eprosartan
135202-79-8Ilonidap
114686-12-3Imitrodast
132418-36-1Rocepafant
132418-35-0Setipafant
2934 90 70125533-88-2Mofarotene
127045-41-4Pazufloxacin
2934 90 80118292-40-3Tazarotene
2934 90 98151356-08-0Afovirsen
138298-79-0Alnespirone
152317-89-0Alniditan
153420-96-3Atibeprone
143393-27-5Azalanstat
149908-53-2Azimilide
150490-85-0Berupipam
154361-50-9Capecitabine
133099-04-4Darifenacin
137500-42-6Darsidomine
114030-44-3Dexpemedolac
115464-77-2Elopiprazole
141790-23-0Fozivudine tidoxil
122254-45-9Glenvastatin
143443-90-7Ifetroban
82857-82-7Ilepcimide
104454-71-9Ipenoxazone
118288-08-7Lafutidine
138068-37-8Lepirudin
78994-23-7Levormeloxifene
116476-16-5Levosemotiadil
148152-63-0Napitane
84558-93-0Netivudine
147432-77-7Ontazolast
139225-22-2Panamesine
103255-66-9Pazinaclone
123447-62-1Prulifloxacin
131986-45-3Xanomeline
145781-32-4Zolasartan
2935 00 90147536-97-8Bosentan
136817-59-9Delavirdine
119905-05-4Delequamine
112966-96-8Domitroban
125279-79-0Ersentilide
139133-26-9Lexipafant
154397-77-0Napsagatran
139133-27-0Nupafant
116649-85-5Ramatroban
133276-80-9Samixogrel
146623-69-0Saprisartan
149556-49-0Susalimod
144494-65-5Tirofiban
139308-65-9Tolafentrine
107753-78-6Zafirlukast
2936 29 90131875-08-6Lexacalcitol
2937 10 109002-68-0Follitropin alfa
152923-57-4Lutropin alfa
2937 22 00103466-73-5Icometasone enbutate
2937 29 90144459-70-1Rofleponide
2937 99 00124478-60-0Aglepristone
140703-51-1Examorelin
133107-64-9Insulin lispro
144743-92-0Teverelix
2939 50 90151581-23-6Apaxifylline
132210-43-6Cipamfylline
100324-81-0Lisofylline
98833-92-2Stacofylline
2939 90 90135905-89-4Mirisetron
117086-68-7Ricasetron
25775-90-0Zucapsaicin
2940 00 90133692-55-4Seprilose
2941 90 00127785-64-2Basifungin
116853-25-9Cefluprenam
122841-10-5Cefoselis
156131-91-8Dimadectin
123997-26-2Eprinomectin
149951-16-6Lenapenem
108852-90-0Nemorubicin
159445-62-2Orientiparcin
156769-21-0Sanfetrinem
3001 90 99120993-53-5Desirudin
3002 10 91143653-53-6Abciximab
156227-98-4Afelimomab
151763-64-3Capromab
152923-56-3Dacliximab
145832-33-3Detumomab
142864-19-5Enlimomab
152981-31-2Inolimomab
150631-27-9Nacolomab tafenatox
159445-64-4Odulimomab
147191-91-1Priliximab
153101-26-9Regavirumab
148189-70-2Votumumab
3002 10 95143090-92-0Anakinra
143631-61-2Atexakin alfa
148637-05-2Cilmostim
154725-65-2Epoetin epsilon
148363-16-0Epoetin omega
102786-52-7Eptacog alfa (activated)
156679-34-4Lenercept
124146-64-1Mobenakin
0-00-0Moroctocog alfa
148641-02-5Muplestim
139076-62-3Octocog alfa
3003 39 000-00-0Plusonermin
3003 90 900-00-0Fuladectin
3507 90 90143831-71-4Dornase alfa
154248-97-2Imiglucerase
149394-67-2Ledimase
156616-23-8Monteplase
159445-63-3Nateplase
155773-57-2Pegorgotein
3911 90 1995522-45-5Colestilan
31512-74-0Polixetonium chloride
3913 90 8039464-87-4Betasizofiran
0-00-0Certoparin sodium
0-00-0Minolteparin sodium
ANNEX II Additional pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to receive duty-free treatment
CN codeCAS RNName
2843 30 0012192-57-3(alpha-D-glucopyranosylthio) gold
2903 69 9042074-68-01-chloro-2-(chlorodiphenylmethyl) benzene
76283-09-5alpha,4-dibromo-2-fluorotoluene
2906 29 90104265-58-92-[(1 S,2R)-6-fluoro-2-hydroxy-1 -isopropyl-1,2,3,4-tetrahydro-2-naphthyl] ethyl p-toluenesulfonate
2907 29 90700-13-02,3,5-tximethylhydroquinone
2909 50 9063659-16-54-[2-(cyclopropylmethoxy) ethyl] phenol
2914 40 9080-75-111-alpha-hydroxypregn-4-ene-3,20-dione
2914 50 002107-69-95,6-dimethoxyindan-1 -one
24916-90-39-beta,11-beta-epoxy-17,21-dihydroxy-l6-alpha-methylpregna-l,4-diene-3,20-dione
2914 70 9083881-08-721-chloro-9-beta, 11 -beta-epoxy-17-hydroxy-16-alpha-methylpregna-1,4-diene-3,20-dione
2915 39 90979-02-220-oxopregna-5,l 6-dien-3-beta-yl acetate
2915 90 20638-41-5pentyl chloroformate
2916 39 0049708-81-8trans-4-(p-chlorophenyl)cyclohexanecarboxylic acid
2917 19 9048059-97-8(E)-oct-4-ene-1,8-dioic acid
71170-82-6triethyl 3-bromopropane-1,1,1-tricarboxylate
2917 39 8027932-00-9indan-5-yl hydrogen phenylmalonate
2918 13 002743-38-6dibenzoyl-L-tartaric acid
2918 17 004358-88-7ethyl DL-mandelate
2918 19 8056188-04-6{(1 R,3R,5S)-3,5-dihydroxy-2-[(E)-(3S)-3-hydroxyoct-1 -enyl]cyclopentyl}acetic acid
2918 29 90167678-46-83-chloroformyl-o-tolyl acetate
2918 30 0056105-81-8(R)-2-(3-benzoylphenyl) propionic acid
22161-86-0(RS)-2-(3-benzoylphenyl) propionic acid
78834-75-0enthyl 7-chloro-2-oxoheptanoate
1944-63-43-[(3aS,4S,7aS)-7a-methyl-1,5-dioxooctahydro-1 H-inden-4-yl]propionic acid
39562-17-9methyl 2-(3-nitrobenzylidene)-3-oxobutyrate
2918 90 9026159-31-9(RS)-2-(6-methoxy-2-naphthyl)propionic acid
105560-93-8methyl (2R,3S)-2,3-epoxy-3-(4-methoxyphenyl) propionate
40098-26-8methyl 7-[(3RS)-3-hydroxy-5-oxocyclopent-1-enyl]heptanoate
2921 19 804261-68-1(2-chloroethyl) diisopropylamine hydrochloride
2921 59 90122-75-8N, N'-dibenzylethylenediammonium di (acetate)
2922 19 00126456-43-7(1S,2R)-1-aminoindan-2-ol
68047-07-44'-[2-(dimethylamino) ethoxy]-2-phenylbutyrophenone
2922 30 00784-38-32-amino-5-chloro-2'-fluorobenzophenone
156732-13-7(S)-5-amino-2-(dibenzylamino)-1,6-diphenylhex-4-en-3-one
2922 49 7037441-29-55-amino-2,4,6-triiodoisophthaloyl dichloride
42854-62-6benzyl L-alaninate--p-toluenesulfonic acid (1:1)
39878-87-0(-)-alpha-(chloroformyl) benzylammonium chloride
54527-73-02-(N-methylbenzylamino) ethyl 3-aminobut-2-enoate
81677-60-3methyl (4-nitrophenyl)-L-alaninate
949-99-53-(4-nitrophenyl)-L-alanine
2924 10 00153758-31-7(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 9040188-45-23'-acetyl-4'-hydroxybutyranilide
1149-26-4N-(benzyloxycarbonyl)-L-valine
116661-86-0(2S,3S)-3-(tert-butoxycarbonylamino)-2-hydroxy-4-phenylbutyric acid
144163-85-9tert-butyl [(1S,3S,4S)-4-amino-1-benzyl-3-hydroxy-5-phenylpentyl] carbamate
149451-80-9tert-butyl [(1S,2S)-1-benzyl-2,3-dihydroxypropyl] carbamate
98737-29-2tert-butyl {(S)-alpha-[(S)-oxiranyl]phenethyl}carbamate
0-00-02-chloro-N-[2-(2-chlorobenzoyl)-4-nitrophenyl] acetamide
125971-96-22-[alpha-(4-fluorobenzoyl)benzyl]-4-methyl-3-oxovaleranilide
32981-85-4methyl (2R,3S)-3-benzamido-2-hydroxy-3-phenylpropionate
2925 19 80151860-15-0meso-N-benzyl-3-nitrocyclopropane-1,2-dicarboximide
97338-03-9ethyl (S)-3-(4-aminopheynl)-2-phthalimidopropionate hydrochloride
94213-26-0ethyl (S)-3-{4-[bis(2-chloroethyl)amino]phenyl}-2-phthalimidopropionate hydrochloride
2926 90 8058311-73-2(Z)-(2-cyanovinyl)trimethylammonium p-toluenesulfonate
133481-10-4ethyl (l-cyanocyclohexl)acetate
123632-23-54-(2,2,3,3-tetrafluoropropoxy)cinnamonitrile
2928 00 9094213-23-7(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine
2930 90 16159453-24-4N-(benzyloxycarbonyl)-S-phenyl-L-cysteine
2930 90 70159878-02-1benzyl (1 R,2S)-3-chloro-2-hydroxy-1 -(phenylthiomethyl)propylcarbamate
136511-43-8ethyl N-{2-[(acetylthio)methyl]-3-(o-tolyl)-1-oxopropyl}-L-methionate
2932 19 0097148-39-5ammonium (Z)-2-methoxyimino-2-(2-furyl)acetate
2932 29 80517-23-7alpha-acetyl-gamma-butyrolactone
6559-91-74'-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
976-70-53-oxopregn-4-ene-21,17-alpha-carbolactone
2932 99 5032981-86-510-deacetylbaccatin III
2932 99 707512-17-62-acetamido-2-deoxy-beta-D-glucopyranose
79944-37-9trans-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
125971-94-0tert-butyl [(4R,6R)-6-(cyanomethyl)-2,2-dimethyl-1,3-dioxolan-4-yl]acetate
467-55-03-beta-hydroxy-5-alpha-spirostan-12-one
533-31-33,4-(methylenedioxy)phenol
2933 11 906150-97-6magnesium bis [(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1 H-pyrazol-4-yl)methylamino]methane- sulfonate
2933 19 9027511-79-13-aminopyrazole-4-carboxamide hemisulfate
2933 29 904897-25-05-chloro-1-methyl-4-nitroimidazole
2933 39 95142057-79-2(RS)-2[(1 -benzyl-4-piperidyl)methyl]-5,6-dimethoxyindan-l -one
120014-07-52-[(l-benzyl-4-piperidyl)methylene]-5,6-dimethoxyindan-1-one
6935-27-9benzyl(2-pyridy l)amine
87848-95-16-bromo-2-pyridyl-p-tolyl ketone
32998-95-1N-(tert-butyl)-3-methylpyridine-2-carboxamide
84449-80-91-[2-(4-carboxyphenoxy)ethyl]piperidinium chloride
83949-32-04-carboxy-4-phenylpiperidinium p-toluenesulfonate
38092-89-68-chloro-6,11-dihydro-11-(l-methyl-4-piperidylidene)-5H-benzo[5,6]cyclohepta[l,2-b]pyridine
31255-57-93-[2-(3-chlorophenyl)ethyl]pyridine-2-carbonitrile
107256-31-53-[2-(3-chlorophenyl)ethyl]-2-pyridyl 1 -methyl-4-piperidyl ketone hydrochloride
6298-19-72-chloro-3-pyridylamine
5424-11-32,2-diphenyl-4-piperidinovaleronitrile
108555-25-51-[2-(4-methoxyphenyl)ethyl]-4-piperidylamine dihydrochloride
4046-24-65-(l -methyl-4-piperidyl)-5H-dibenzo[a,d]cyclohepten-5-ol hydrochloride
139886-04-71-methyl-1,2,5,6-tetrahydropyridine-3-carbaldehyde (E)-O-methyloxime hydrochloride
70708-28-01-(2-pyridyl)-3-(pyrrolidin-1-yl)-1-(p-tolyl)propan-1-ol
1619-34-7quinuclidin-3-ol
2933 40 10105956-96-57-[3-(tert-butoxycarbonylamino)pyrrolidin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroc quinoline-3-carboxylic acid
86393-33-17-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
112811-72-01-cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
98349-25-8ethyl 1 -cyclopropyl-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate
2933 40 90159878-04-3benzyl (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)
120578-03-23-[(E)-2-(7-chloro-2-quinolyl)vinyl]benzaldehyde
1087-69-0(9S,13S,14S)-3-methoxymorphinan hydrochloride
64228-78-0pentamethylene bis {3-[10-(3,4-dimethoxybenzyl)-6,7-dimethoxy-1,2,3,4-tetrahydro-2-isoquinolyl] propionate]- -oxalic acid (1:2)
2933 59 7075128-73-32-[(2-acetamido-6-oxo-6,9-dihydro-1H-purin-9-yl)methoxy]ethyl acetate
3056-33-5N-(9-acetyl-6-oxo-6,9-dihydro-1H-purin-2-yl)acetamide
10310-21-12-amino-6-chloropurine
124832-31-12-[(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
41202-32-81-(2-chlorophenyl)piperazine hydrochloride
13078-15-41-(3-chlorophenyl)piperazine hydrochloride
71-30-7cytosine
149062-75-91,3-dichloro-6,7,8,9,1 0,1 2-hexahydroazepino[2,1 -b]quinazoline hydrochloride
41202-77-11-(2,3-dichlorophenyl)piperazine hydrochloride
56177-80-12-ethoxy-5-fluoropyrimidin-4(1 H)-one
112733-45-6ethyl (7-chloro-2,4-dioxo-1,2,3,4-tetrahydroquinazolin-l -yl)acetate
59703-00-34-ethyl-2,3-dioxopiperazine-l-carbonyl chloride
64090-19-31-(4-fluorophenyl)piperazine dihydrochloride
147539-21-7isopropyl[2-(piperazin-1-yl)-3-pyridyl]amine
35386-24-41-(2-methoxyphenyl)piperazine
5464-78-81-(2-methoxyphenyl)piperazine hydrochloride
145012-50-6(7RS,9aRS)-perhydropyrido[l,2-a]pyrazin-7-ylmethanol
2210-93-71-phenylpiperazinium chloride
111641-17-94-(piperazin-1-yl)-2,6-bis(pyrrolidin-1-yl)pyrimidine
68-94-0purin-6(1 H)-one
70849-60-41-(o-tolyl)piperazine hydrochloride
2933 69 8058909-39-0tetrahydro-2-methyl-3-thioxo-1,2,4-triazine-5,6-dione
2933 79 00135297-22-2(3S,4R)-3-[(R)-1-(tert-butyldimethylsilyloxy)ethyl]-4-[(lR,3S)-3-methoxy-2-oxocyclohexyl]azetidin-2-one
141646-08-41-|[(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
75363-99-4p-nitrobenzyl (2R,5R,6S)-6-[(R)-1-hydroxyethyl]-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate
141316-45-2potassium 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 6059467-64-0[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)
59467-69-58-chloro-6-(2-fluorophenyl)-1-methyl-3a,4-dihydro-3H-imidazo[l,5-a][l,4]benzodiazepine
59469-63-57-chloro-5-(2-fluorophenyl)-3-methyl-2-(nitromethylene)-2,3-dihydro-1 H-1,4-benzodiazepine 4-oxide
59467-63-97-chloro-5-(2-fluorophenyl)-2(nitromethylene)-2,3-dihydro-1 H-1,4-benzodiazepine
2933 90 95130404-91-0N-[(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)
122536-48-53-[(S)-3-(L-alanylamino)pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3- carboxylic acid hydrochloride
122536-91-87-{(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
134575-17-0tert-butyl meso-3-azabicyclo[3.1.0]hex-6-ylcarbamate
122536-66-7tert-butyl [(S)-1-methyl-2-oxo-2-[(S)-pyrrolidin-3-ylamino]ethyl}carbamate
140629-77-2tert-butyl [(RS)-pyrrolidin-3-yl] carbamate
100361-18-07-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
38150-27-55-chloro-2-[3-(hydroxymethyl)-5-methyl-4H-1,2,4-triazol-4-yl]ben2Ophenone
36916-19-55-chloro-2-(3-methyl-4H-1,2,4-triazol-4-yl)benzophenone
54196-62-22',5-dichloro-2-[3-(hydroxymethyl)-5-methyl-4H-1,2,4-triazol-4-yl]benzophenone
54196-61-12',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
144034-80-0dimethyl{2-[5-(1 H-1,2,4-triazol-1-ylmethyl)indol-3-yl]ethyl}amine
122665-86-5ethyl [3-(cyanomethyl)-4-oxo-3,4-dihydrophthalazin-1 -yl]acetate
41340-36-72-(7-ethyl-lH-indol-3-yl)ethanol
95885-13-55-ethyl-4-(2-phenoxyethyl)-4H-1,2,4-triazol-3(2H)-one
96107-94-7ethyl 1 H-tetrazole-5-carboxylate, sodium salt
96034-57-0trans-4-hydroxy-1-(4-nitrobenzyloxycarbonyl)-L-proline
160194-26-32-iodo-4-(1 H-1,2,4-triazol-1-ylmethyl)aniline
66635-71-0isopropyl 2,3-dihydro-1 H-pyrrolizine-1-carboxylate
4928-88-5methyl 1 H-1,2,4-triazole-3-carboxylate
0-00-01,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid sulfate
112193-77-81,4,7,10-tetraazoniacyclododecane bis(sulfate)
3641-08-51 H-l,2,4-triazole-3-carboxamide
4928-87-41 H-1,2,4-triazole-3-carboxylic acid
6969-71-71,2,4-triazolo[4,3-a]pyridin-3(2H)-one
2934 10 00171485-87-32-[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
76823-93-31-{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
64485-88-7ethyl (Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino) acetate
66339-00-2ethyl 2-(hydroxyimino)-2-[2-(tritylamino)thiazol-4-yl]acetate hydrochloride
88046-01-92-guanidinothiazol-4-ylmethyl carbamimidothioate dihydrochloride
154212-61-0N-[2-isopropylthiazol-4-ylmethyl(methyl)carbamoyl]-L-valine
66215-71-2(Z)-2-methoxyimino-2-[2-(tritylamino)thiazol-4-yl] acetic acid
154212-59-64-nitrophenyl thiazol-5-ylmethyl carbonate hydrochloride
38585-74-9thiazol-5-ylmethanol
155213-67-5thiazol-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 5080756-85-0S-(benzothiazol-2-yl) (Z)-2-(2-aminothiazol-4-yl)-2-methoxyiminothioacetate
2934 20 9087691-88-11-(1,2-benzisothiazol-3-yl)piperazine hydrochloride
2934 90 50111974-69-72-{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 60115787-67-22-(2-amino-5-nitro-6-oxo-1,6-dihydropyrimidin-4-yl)-3-(3-thienyl)propiononitrile
117829-20-62-amino-7-thenyl-1,7-dihydro-4H-pyrrolo[2,3-d]pyrimidin-4-one hydrochloride
112887-68-0N-{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)
104795-66-63-isopropoxy-5-methoxy-N-(1H-tetrazol-5-yl)benzo[b]thiophene-2-carboxamide
104795-67-73-isopropoxy-5-methoxy-N-(1H-tetrazoI-5-yl)benzo[b]thiophene-2-carboxamide-1H-imidazole (1:1)
104795-68-83-isopropoxy-5-methoxy-N-(1H-tetrazol-5-yl)benzo[b]thiophene-2-carboxamide, sodium salt
63675-74-16-methoxy-2-(4-methoxyphenyl)benzo[b]thiophene
138564-59-75-methyl-2-(2-nitroanilino)thiophene-3-carbonitrile
2934 90 7025229-97-42-cyano-3-morpholinoacrylamide
2934 90 80119221-49-75-[(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 9858-61-7adenosine
152305-23-2(S)-4-(4-aminobenzyl)oxazolidin-2-one
71420-85-47-amino-3-[1-(sulfomethyl)-1H-tetrazol-5-ylthiomethyl]-3-cephem-4-carboxylic acid, sodium salt
29706-84-13'-azido-3'-deoxy-5'-0-tritylthymidine
51762-51-7benzhydryl 3-hydroxy-7-(phenylacetamido)cepham-4-carboxylate
110314-42-65-[(benzofuran-2-ylcarbonyl)amino]indole-2-carboxylic acid
131986-28-23-(4-chloro-1,2,5-thiadiazol-3-yl)pyridine
107452-89-1omega-conotoxin M VIIA
126429-09-22-(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
4097-22-72',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
140841-32-36-[3-fluoro-5-(4-methoxytetrahydropyran-4-yl)phenoxymethyl]-1-methyl-2-quinolone
94732-98-61-(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
131988-19-73-(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
104218-44-23'-O-mesyl-5'-O-tritylthymidine
27255-72-73-methyl-7-(phenylacetamido)-3-cephem-4-carboxylic acid
0-00-0(1R,2S,3S,6R)-[(S)-1-phenylethyl]-3,6-epoxytetrahydrophthalimide
32231-06-41-piperonylpiperazine
55612-11-85'-O-tritylthymidine
2935 00 90151140-66-8(4-amino-3-iodophenyl)-N-methylmethanesulfonamide
112101-81-25-[(R)-(2-aminopropyl)]-2-methoxybenzenesulfonamide
120298-38-6N-(5,6-dihydro-6-methyl-2-sulfamoyl-4H-thieno[2,3-b]thiopyran-4-yl)acetamide 7,7-dioxide
150975-95-45-methanesulfonamidoindole-2-carboxylic acid
84522-34-9sodium 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzenesulfonamide
2939 10 0066820-84-6(RS)-tetrahydropapaverine hydrochloride
2940 00 9013035-61-51,2,3,5-tetraacetyl-beta-D-ribofuranose
3824 90 64330-95-01,3-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)
0-00-0Intermediate 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
0-00-0Intermediate 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
0-00-0Intermediate concentrates obtained from a Micromonospora inyoensis fermentation medium used for the manufacture of the antibiotics sisomicin (INN) and netilmicin (INN)
0-00-0Intermediate concentrates obtained from a Micromonospora purpurea fermentation medium used for the manufacture of the antibiotics gentamicin sulfate (INNM) and isepamicin (INN)
3824 90 950-00-0ethyl 7-chloro-2-oxoheptanoate, in the form of a solution in toluene
3911 90162430-94-61,6-hexanediamine, polymer with 1,10-dibromodecane
3913 90 8083513-48-8danaparoid 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 codeCAS RNName
2903 22 0079-01-6trichloroethylene
2903 30 10811-97-2norflurane
2903 51 1058-89-9lindane
2906 21 00100-51-6benzyl alcohol
2915 29 0082279-57-0zinc acetate, basic
2922 41 0056-87-1lysine
2922 42 9056-86-0glutamic acid
2922 49 1056-40-6glycine
2922 50 0072-19-5threonine
2923 10 1067-48-1choline chloride
2928 00 9079-17-4pimagedine
2930 90 20111-48-8thiodiglycol
2933 90 9573-22-3tryptophan
3102 70 10156-62-7calcium carbimide
3904 61 109002-84-0politef
3906 90 9054182-57-9carbomer
3907 200-00-0macrogol ester
3907 20 1225322-68-3macrogol
3907 20 2125301-02-4tyloxapol
3907 60 1025038-59-9pegoterate
3908 10 0025038-54-4policapram
3910 00 009006-65-9dimeticone
3912 20 119004-70-0pyroxylin
3912 31 009000-11-7carmellose
3912 39 808063-82-9hypromellose