Address https://gelex.eu/eli/EU/regulation/1997/467@1997-03-03/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3
   4. Article 4
   5. Article 5
3. ANNEX
4. ANNEX I Additional INNs to receive duty-free treatment
5. ANNEX II Additional pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to receive duty-free treatment
6. ANNEX III Additions to the list of prefixes and suffixes which, in combination with the INNs, describe salts, esters or hydrates of INNs
7. ANNEX IV INNs which shall no longer benefit from duty-free treatment

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

ANNEX I Additional INNs to receive duty-free treatment

CN code CAS RN Name 28444030 113716-48-6 Iolopride (123 I) 142481-95-6 Technetium (99m Tc) furifosmin 28469000 131069-91-5 Gadoversetamide 135326-11-3 Gadoxetic acid 138721-73-0 Sprodiamide 29144090 20098-14-0 Idramantone 29163900 71109-09-6 Vedaprofen 29183000 22161-81-5 Dexketoprofen 112665-43-7 Seratrodast 29189090 139403-31-9 Pimilprost 29214990 136236-51-6 Rasagiline 29224970 6582-31-6 Dapabutan 29239000 1794-75-8 Laurcetium bromide 29241000 1675-66-7 Adelmidrol 62304-98-7 Thymalfasin 132787-19-0 Tradecamide 129009-83-2 Versetamide 29242990 147362-57-0 Loviride 94497-51-5 Tamibarotene 29251980 144849-63-8 Bisnafide 29252000 137159-92-3 Aptiganel 29269080 137109-71-8 Balazipone 147076-36-6 Laflunimus 29280090 141579-54-6 Fenleuton 29309016 87573-01-1 Salnacedin 29309070 90357-06-5 Bicalutamide 112573-72-5 Dexecadotril 107023-41-6 Pobilukast 81110-73-8 Racecadotril 29310050 132236-18-1 Zifrosilone 29310080 114084-78-5 Ibandronic acid 124351-85-5 Incadronic acid 63132-39-8 Olpadronic acid 29329970 105674-77-9 Lanproston 29329990 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 29332990 158682-68-9 Elisartan 116684-92-5 Galdansetron 89371-44-8 Imidaprilat 138402-11-6 Irbesartan 118072-93-8 Zoledronic acid 29333995 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 29334010 127294-70-6 Balofloxacin 143383-65-7 Premafloxacin 143224-34-4 Telinavir 29334090 96946-42-8 Cisatracurium besilate 158966-92-8 Montelukast 136668-42-3 Quiflapon 29335970 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 29337900 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 29339095 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 29341000 149079-51-6 Cartasteine 128312-51-6 Cinalukast 51287-57-1 Denotivir 101001-34-7 Pamicogrel 136433-51-7 Tazofelone 138742-43-5 Zankiren 29342090 144665-07-6 Lubeluzole 150915-41-6 Perospirone 146939-27-7 Ziprasidone 29349060 130370-60-4 Batimastat 133040-01-4 Eprosartan 135202-79-8 Ilonidap 114686-12-3 Imitrodast 132418-36-1 Rocepafant 132418-35-0 Setipafant 29349070 125533-88-2 Mofarotene 127045-41-4 Pazufloxacin 29349080 118292-40-3 Tazarotene 29349098 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 29350090 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 29362990 131875-08-6 Lexacalcitol 29371010 9002-68-0 Follitropin alfa 152923-57-4 Lutropin alfa 29372200 103466-73-5 Icometasone enbutate 29372990 144459-70-1 Rofleponide 29379900 124478-60-0 Aglepristone 140703-51-1 Examorelin 133107-64-9 Insulin lispro 144743-92-0 Teverelix 29395090 151581-23-6 Apaxifylline 132210-43-6 Cipamfylline 100324-81-0 Lisofylline 98833-92-2 Stacofylline 29399090 135905-89-4 Mirisetron 117086-68-7 Ricasetron 25775-90-0 Zucapsaicin 29400090 133692-55-4 Seprilose 29419000 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 30019099 120993-53-5 Desirudin 30021091 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 30021095 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 30033900 0-00-0 Plusonermin 30039090 0-00-0 Fuladectin 35079090 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 39119019 95522-45-5 Colestilan 31512-74-0 Polixetonium chloride 39139080 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 28433000 12192-57-3 (alpha-D-glucopyranosylthio) gold 29036990 42074-68-0 1-chloro-2-(chlorodiphenylmethyl) benzene 76283-09-5 alpha,4-dibromo-2-fluorotoluene 29062990 104265-58-9 2-[(1 S,2R)-6-fluoro-2-hydroxy-1 -isopropyl-1,2,3,4-tetrahydro-2-naphthyl] ethyl p-toluenesulfonate 29072990 700-13-0 2,3,5-tximethylhydroquinone 29095090 63659-16-5 4-[2-(cyclopropylmethoxy) ethyl] phenol 29144090 80-75-1 11-alpha-hydroxypregn-4-ene-3,20-dione 29145000 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 29147090 83881-08-7 21-chloro-9-beta, 11 -beta-epoxy-17-hydroxy-16-alpha-methylpregna-1,4-diene-3,20-dione 29153990 979-02-2 20-oxopregna-5,l 6-dien-3-beta-yl acetate 29159020 638-41-5 pentyl chloroformate 29163900 49708-81-8 trans-4-(p-chlorophenyl)cyclohexanecarboxylic acid 29171990 48059-97-8 (E)-oct-4-ene-1,8-dioic acid 71170-82-6 triethyl 3-bromopropane-1,1,1-tricarboxylate 29173980 27932-00-9 indan-5-yl hydrogen phenylmalonate 29181300 2743-38-6 dibenzoyl-L-tartaric acid 29181700 4358-88-7 ethyl DL-mandelate 29181980 56188-04-6 {(1 R,3R,5S)-3,5-dihydroxy-2-[(E)-(3S)-3-hydroxyoct-1 -enyl]cyclopentyl}acetic acid 29182990 167678-46-8 3-chloroformyl-o-tolyl acetate 29183000 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 29189090 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 29211980 4261-68-1 (2-chloroethyl) diisopropylamine hydrochloride 29215990 122-75-8 N, N'-dibenzylethylenediammonium di (acetate) 29221900 126456-43-7 (1S,2R)-1-aminoindan-2-ol 68047-07-4 4'-[2-(dimethylamino) ethoxy]-2-phenylbutyrophenone 29223000 784-38-3 2-amino-5-chloro-2'-fluorobenzophenone 156732-13-7 (S)-5-amino-2-(dibenzylamino)-1,6-diphenylhex-4-en-3-one 29224970 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 29241000 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 29242990 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 29251980 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 29269080 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 29280090 94213-23-7 (Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine 29309016 159453-24-4 N-(benzyloxycarbonyl)-S-phenyl-L-cysteine 29309070 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 29321900 97148-39-5 ammonium (Z)-2-methoxyimino-2-(2-furyl)acetate 29322980 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 29329950 32981-86-5 10-deacetylbaccatin III 29329970 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 29331190 6150-97-6 magnesium bis [(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1 H-pyrazol-4-yl)methylamino]methane- sulfonate 29331990 27511-79-1 3-aminopyrazole-4-carboxamide hemisulfate 29332990 4897-25-0 5-chloro-1-methyl-4-nitroimidazole 29333995 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 29334010 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 29334090 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) 29335970 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 29336980 58909-39-0 tetrahydro-2-methyl-3-thioxo-1,2,4-triazine-5,6-dione 29337900 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 29339060 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 29339095 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 29341000 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 29342050 80756-85-0 S-(benzothiazol-2-yl) (Z)-2-(2-aminothiazol-4-yl)-2-methoxyiminothioacetate 29342090 87691-88-1 1-(1,2-benzisothiazol-3-yl)piperazine hydrochloride 29349050 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 29349060 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 29349070 25229-97-4 2-cyano-3-morpholinoacrylamide 29349080 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 29349098 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 29350090 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 29391000 66820-84-6 (RS)-tetrahydropapaverine hydrochloride 29400090 13035-61-5 1,2,3,5-tetraacetyl-beta-D-ribofuranose 38249064 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) 38249095 0-00-0 ethyl 7-chloro-2-oxoheptanoate, in the form of a solution in toluene 391190 162430-94-6 1,6-hexanediamine, polymer with 1,10-dibromodecane 39139080 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 29032200 79-01-6 trichloroethylene 29033010 811-97-2 norflurane 29035110 58-89-9 lindane 29062100 100-51-6 benzyl alcohol 29152900 82279-57-0 zinc acetate, basic 29224100 56-87-1 lysine 29224290 56-86-0 glutamic acid 29224910 56-40-6 glycine 29225000 72-19-5 threonine 29231010 67-48-1 choline chloride 29280090 79-17-4 pimagedine 29309020 111-48-8 thiodiglycol 29339095 73-22-3 tryptophan 31027010 156-62-7 calcium carbimide 39046110 9002-84-0 politef 39069090 54182-57-9 carbomer 390720 0-00-0 macrogol ester 39072012 25322-68-3 macrogol 39072021 25301-02-4 tyloxapol 39076010 25038-59-9 pegoterate 39081000 25038-54-4 policapram 39100000 9006-65-9 dimeticone 39122011 9004-70-0 pyroxylin 39123100 9000-11-7 carmellose 39123980 8063-82-9 hypromellose

Versions

1. 1997-03-03