Proposal for a COUNCIL REGULATION (EC) providing for duty free treatment for specified pharmaceutical active ingredients bearing an "international nonproprietary name" (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and withdrawing duty free treatment as pharmaceutical products from certain INNs whose predominate use is not pharmaceutical
i COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 11. 12 1996 COM(96) 563 final 96/0268 (ACC) Proposal for a COUNCIL REGULATION (EC) Providing for duty free treatment for specified pharmaceutical active ingredients bearing an "international nonproprietary name" (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and withdrawing duty free treatment as pharmaceutical products from certain INNs whose predominate use is not pharmaceutical. (presented by the Commission) EXPLANATORY MEMORANDUM 1. Pursuant to the conclusions reached in Uruguay Round Record of Discussions (L/4740 of 25. 3. 1994) on duty free treatment for pharmaceutical products, the Commission has participated in the first review of the product coverage to include, by consensus, additional products for duty free treatment. 2. The outcome of the review is that 231 pharmaceutical active ingredients bearing an "international nonproprietary name" (INN) from the World Health Organisation and 234_products used for the manufacture of finished pharmaceuticals should be added to the list of products already receiving duty free treatment and also that the list of specified prefixes and suffixes for salts and esters of INNs should be expanded by 84 names. 3. In addition it was concluded that the situation should be rectified in respect of 25 INNs whose use was predominantly non-pharmaceutical by deleting them from the list of INNs receiving duty free treatment. 4. The Commission proposes in line with other countries granting duty free treatment for these additional products as early as possible in 1997 that the duty free treatment shall commence from 1. 1. 97. 5. For these reasons the Commission proposes that the Council adopt the Regulation contained in the Annex to this communication. a. PROPOSAL FOR A COUNCIL REGULATION (EC) Providing for duty free treatment for specified pharmaceutical active ingredients bearing an "international nonproprietary name" (INN) from the World Health Organisation 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 in the Harmonised 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 nonproprietary name" (INN) from the World Health Organisation as well as specified salts, esters and hydrates of such products, 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 Discussions1, 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 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. 1 GATT Document L/7430 HAS ADOPTED THIS REGULATION: Article 1 From 1 January 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 January 1997 the Community shall also accord duty free treatment for the products used in the production and manufacture of pharmaceutical products listed in Annex II. Article 3 From 1 January 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 January 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, For the Council The President \ Additional INNs to receive duty free treatment Annex I Annex II Additional pharmaceutical intermediates, ie compounds used for the manufacture of finished pharmaceutical products, to receive duty free treatment. Annex III Additions to the list of prefixes and suffixes which, in combination with the INNs, describe salts, esters or hydrates of INNs. INNs which shall no longer benefit from duty free treatment Annex IV FINANCIAL STATEMENT Section 1. Financial Implications 1. Proposal for a Council Regulation providing duty free treatment for 465 pharmaceutical products and withdrawing duty free treatment from 25 products whose predominant use is not pharmaceutical. 2. Budget heading: (loss of revenue: not known) 3. Legal basis: Article 113 4. Description The proposal regulation is a consequence of the agreement reached in the Uruguay Round to undertake a periodic review of the agreement with a view to including, by consensus, additional products for duty free treatment. 5. Type of revenue: Loss of revenue for duties paid on third country imports. 6. Change in level of revenue: The withdrawal of duty free treatment from products whose use was predominantly non-pharmaceutical with subsequent revenue gains will offset a large proportion of the revenue loss for duty free treatment being granted to other products. No figures are available for the amounts involved but with this element taken into account the duty loss is likely to be less than 2 MECU. Annex I Additional INNs to receive duty free treatment •\ CN code CAS KW Nam» 2844 40 30 2846 90 00 2914 40 90 2916 39 00 2918 30 00 2918 90 90 2921 49 90 2922 49 70 2923 90 00 2924 10 00 2924 29 90 2925 19 80 2925 20 00 2926 90 80 2928 00 90 2930 90 16 2930 90 70 2931 00 50 2931 00 80 2932 99 70 2932 99 90 2933 29 90 2933 39 95 2933 40 10 113716-48-6 142481-95-6 131069-91-5 135326-11-3 138721-73-0 20098-14-0 71109-09-6 22161-81-5 112665-43-7 139403-31-9 136236-51-6 6582-31-6 1794-75-8 1675-66-7 62304-98-7 132787-19-0 129009-83-2 147362-57-0 94497-51-5 144849-63-8 137159-92-3 137109-71-8 147076-36-6 141579-54-6 87573-01-1 90357-06-5 112573-72-5 107023-41-6 81110-73-8 132236-18-1 114084-78-5 124351-85-5 63132-39-8 105674-77-9 123407-36-3 132017-01-7 110816-79-0 149494-37-1 151581-24-7 113806-05-6 139110-80-8 158682-68-9 116684-92-5 89371-44-8 138402-11-6 118072-93-8 119257-34-0 118248-91-2 155415-08-0 121750-57-0 144412-49-7 155319-91-8 150443-71-3 29876-14-0 144035-83-6 137795-35-8 147025-53-4 149488-17-5 127294-70-6 143383-65-7 143224-34-4 iolopride (123 I) technetium (99m Tc) furifosmin gadoversetamide gadoxetic acid sprodiamide idramantone vedaprofen dexketoprofen seratrodast pimilprost rasagiline dapabutan laurcetium bromide adelmidrol thymalfasin tradecamide versetamide loviride tamibarotene bisnafide aptiganel balazipone laflunimus fenleuton salnacedin bicalutamide dexecadotril pobilukast racecadotril zifrosilone ibandronic acid incadronic acid olpadronic acid lanproston arteflene bervastatin cromoglicate lisetil ebalzotan iralukast olopatadine zanamivir elisartan galdansetron imidaprilat irbesartan zoledronic acid besipirdine fodipir inogatran itameline lamifiban mangafodipir nicanartine nicotredole piclamilast spiroglumide talsaclidine trovirdine balofloxacin premafloxacin telinavir 2933 40 90 2933 40 90 2933 59 70 2933 79 00 2933 90 95 2934 10 00 2934 20 90 2934 90 60 2934 90 70 2934 90 80 2934 90 98 96946-42-8 158966-92-8 136668-42-3 127266-56-2 106941-25-7 113852-37-2 150756-35-7 119687-33-1 127759-89-1 140945-32-0 134208-17-6 96604-21-6 148504-51-2 115762-17-9 118420-47-6 137234-62-9 151319-34-5 148396-36-5 74436-00-3 143943-73-1 106730-54-5 135548-15-1 145733-36-4 143343-83-3 137882-98-5 114607-46-4 120511-73-1 134523-00-5 128270-60-0 139481-59-7 54278-85-2 105806-65-3 62568-57-4 120081-14-3 142880-36-2 62732-44-9 116287-14-0 112809-51-5 116644-53-2 136122-46-8 144702-17-0 132036-88-5 106308-44-5 144701-48-4 147059-72-1 149079-51-6 128312-51-6 51287-57-1 101001-34-7 136433-51-7 138742-43-5 144665-07-6 150915-41-6 146939-27-7 130370-60-4 133040-01-4 135202-79-8 114686-12-3 132418-36-1 132418-35-0 125533-88-2 127045-41-4 118292-40-3 151356-08-0 cisatracurium besilate montelukast quiflapon adatanserin adefovir cidofovir efletirizine iganidipine lobucavir mapinastine mazapertine ocinaplon ripisartan ruzadolane tagorizine voriconazole zaleplon fradafiban geclosporin lirequinil olprinone oxeclosporin tasosartan toborinone abitesartan acitazanolast anastrozole atorvastatin bivalirudin candesartan candocuronium iodide efegatran emideltide goralatide ilomastat ipidacrine lanperisone letrozole mibefradil mipitroban pomisartan ramosetron rufinamide telmisartan trovafloxacin cartasteine cinalukast denotivir pamicogrel tazofelone zankiren lubeluzole perospirone ziprasidone batimastat eprosartan ilonidap imitrodast rocepafant setipafant mofarotene pazufloxacin tazarotene afovirsen 138298-79-0 152317-89-0 153420-96-3 143393-27-5 149908-53-2 150490-85-0 154361-50-9 133099-04-4 137500-42-6 114030-44-3 115464-77-2 141790-23-0 122254-45-9 143443-90-7 82857-82-7 104454-71-9 118288-08-7 138068-37-8 78994-23-7 116476-16-5 148152-63-0 84558-93-0 147432-77-7 139225-22-2 103255-66-9 123447-62-1 131986-45-3 145781-32-4 147536-97-8 136817-59-9 119905-05-4 112966-96-8 125279-79-0 139133-26-9 154397-77-0 139133-27-0 116649-85-5 133276-80-9 146623-69-0 149556-49-0 144494-65-5 139308-65-9 107753-78-6 131875-08-6 9002-68-0 152923-57-4 103466-73-5 144459-70-1 124478-60-0 140703-51-1 133107-64-9 144743-92-0 151581-23-6 132210-43-6 100324-81-0 98833-92-2 135905-89-4 117086-68-7 25775-90-0 133692-55-4 127785-64-2 116853-25-9 122841-10-5 156131-91-8 alnespirone alniditan atibeprone azalanstat azimilide berupipam capecitabine darifenacin darsidomine dexpemedolac elopiprazole fozivudine tidoxil glenvastatin ifetroban ilepcimide ipenoxazone lafutidine lepirudin levormeloxifene levosemotiadil napitane netivudine ontazolast panâmesine pazinaclone prulifloxacin xanomeline zolasartan bosentan delavirdine delequamine domitroban ersentilide lexipafant napsagatran nupafant ramatroban samixogrel saprisartan susalimod tirofiban tolafentrine zafirlukast lexacalcitol follitropin alfa lutropin alfa icometasone enbutate rofleponide aglepristone examorelin insulin lispro teverelix apaxifylline cipamfylline lisofylline stacofylline mirisetron ricasetron zucapsaicin seprilose basifungin cefluprenam cefoselis dimadectin fa 2935 00 90 2936 29 90 2937 10 10 2937 22 00 2937 29 90 2937 99 00 2939 50 90 2939 90 90 2940 00 90 2941 90 00 2941 90 00 123997-26-2 149951-16-6 108852-90-0 159445-62-2 156769-21-0 120993-53-5 143653-53-6 156227-98-4 151763-64-3 152923-56-3 145832-33-3 142864-19-5 152981-31-2 150631-27-9 159445-64-4 147191-91-1 153101-26-9 148189-70-2 143090-92-0 143631-61-2 148637-05-2 154725-65-2 148363-16-0 102786-52-7 156679-34-4 124146-64-1 0-00-0 148641-02-5 139076-62-3 0-00-0 0-00-0 143831-71-4 154248-97-2 149394-67-2 156616-23-8 159445-63-3 155773-57-2 95522-45-5 31512-74-0 39464-87-4 0-00-0 0-00-0 eprinomectin lenapenem nemorubicin orientiparcin sanfetrinem desirudin abciximab afelimomab capromab dacliximab detumomab enlimomab inolimomab nacolomab tafenatox odulimomab priliximab regavirumab votumumab anakinra atexakin alfa cilmostim epoetin epsilon epoetin omega eptacog alfa (activated) lenercept mobenakin moroctocog alfa muplestim octocog alfa plusonermin fuladectin dornase alfa imiglucerase ledismase monteplase nateplase pegorgotein colestilan polixetonium chloride betasizofiran certoparin sodium minolteparin sodium 3001 90 99 3002 10 91 3002 10 95 3003 39 00 3003 90 90 3507 90 90 3911 90 19 3913 90 80 11 Annex II Additional pharmaceutical intermediates, ie compounds used for the manufacture of finished pharmaceutical products, to receive duty free treatment. 43. est coda CAS R» game ^^ 2843 30 00 2903 69 90 12192-57-3 (alpha-D-glucopyranosylthioJgold 42074-68-0 l-chloro-2-(chlorodiphenylmathyl)benzene 76283-09-5 alpha,4-dibromo-2-filuorotoluene 2906 29 90 104265-58-9 2-[(is,2R)-6-fluoro-2-hydroxy-1-isoprdpyl- l,2,3,4-tetrahydro-2-naphthyllethyl p- toluenasulfonate 2907 29 90 2909 50 90 2914 40 90 2914 50 00 700-13-0 2, 3,5-triraethylhydjroquinane 63659-16-5 4- [2-(cyclopropylmethoxy)ethyl]phenol 80-75-1 ll-alpha-hydroxypregn-4-9ne-3,20-d±ane 2107-69-9 5,6-diraethoxyindan-l-one 2914 70 90 2915 39 90 2915 90 20 291a 39 00 2917 19 90 2917 39 80 2918 13 00 2918 17 00 2918. 19 80 24916-90-3 9-beta,11-beta-epoxy-l7,2l-dihydroxy-lS-alpha- methylpregna-l,4-diene-3,20-dione 83881-08-7 21-chloro-9-beta",11-beta-epoxy-17-hydroxy-16- alpha-methylpregna-1,4-diene-3,20-dione 979-02-2 2Q~oxopregna-5,16-dien-3-beta-yl acetate 638-41-5 pexityl chloroformate -. -, 49708-81-8 trans-4-(p-ahlorophenyl)^yClohexanecarboxylic acid 48059-97-8 (B) -oct-4-ei»r-l, 8-dloic "acid 71170-82-6 triethyl 3-bramopropane-l,1,1-tricarboxylate 27932-00-9 indan-5-yl hydrogen phenylmalonate 2743-38-6 dibenzoyl-L-tartaric acid 4358-88-7 ethyl DL-mandel'at* 563. 88-04-6 {(lit, 3R, 5S) ~3 , 5-dlhydroxy-2- [ (E) - (3S) -3- hydroxyoct-l-enyl]cyclopentyl}ac«tic acid 2918 29 90 167678-46-8 3-chloroformyl-o-tolyl acetate 2918 30-00 56105-81-8 (R) -2-(3-benzaylphenyl)propionic acid 22161-86-0 • {RS)~2-{3-benzoylphenyl)propionic acid 78834-75-0 ethyl 7-chloro-2-cocoheptanoate 1944-S3-4 3- [ (3aS,4S,7aS)-7a-methyl-l,S-dioxoactahydro- lH-inden-4-yl]propionic acid 2918 90 90 39562-17-9 methyl 2-(3-nitrobenzylidene)-3-oxobutyrate 26159-31-9 (RS)-2-(6-methoxy-2-naphchyl)propionic, acid 105560-93-8 methyl (2R,3S)-2,3-epoxy-3-(4- methoxyphenyl)propionate 40098-26-8 methyl 7-[(3RS)-3-hydrpxy-S-oxocyclopent-l- enyl]heptanoate 2921 19 so 2921 59 90 2922 19 00 126456-43-7 (IS, 2R)-l-aminoindan-2-ol 4261-68-1 (2-chloroethyl)diisopropylamine hydrochloride 122-75-8 N,N'-dibenzylethylenediammonium di(acetate) 68047-07-4 4'-[2-(dimethylamino)ethoxy]-2- phenylbutyrophenone 2922 30 00 784-38-3 2~araino-5-chloro-2'-fluorob«nzophenone 156732-13-7 (S)-5-amino-2-(dibenzylamino)-l,6~diphenylhex- 2922 49 70 37441-29-5 5-amino-2,4,6-triiodoisophthaloyl dichloride 42854-62-6 ben2yl L-alaninate--p-toluenesulfonic acid 4~en73-one 39878-87-0 (-)-alpha- (chloroformyl)benzylammonium (1:1) 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-aminb-3-hydroxy-N-pentylpropionamide-- oxalic acid (1:1) e ANNEX II CM code CAS RM Name 13 8531-07-4 L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L- lyayl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L- lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L- lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L- lysine 2924 29 90 2924 29 90 4018B-45-2 3'-aoetyl-4'-hydroxybutyranilide 1149-26-4 N-(banzyloxycarbonyl)-L-valine 116661-86-0 (2S,3S)-3-(tert-butoxycarbonylamino)-2- bydroxy-4-pheiiylbutyric acid 144163-85-9 tert-butyl [(is,3S,4S)-4-amiao-l-benzyl-3- hydroxy-5-phenylpentylJcarbamate 149451-80-9 tert-butyl [(IS,2S)-l-benzyl-2,3- dihydroxypropyl]carbamate 98737-29-2 tert-butyl {IS)-alpha-[(S)- oxiranyl]phenethyl}carbamate 0-00-0 2-chloro-N-[2-(2-chlorob9nzoyl)-4- nitrophenyl]acetamide 125971-96-2 2- [alpha-(4-fluorobenzoyl)benzyl]-4-methyl-3- oxovaleranilide 32981-8S-4 methyl (2R,3S)-3-benzamido-2-hydroxy-3- phenylpropionate 292. 5 19 80 151860-15-0 meeo-N-benzyl-3-nitrocyclopropane-1,2- dicarboximide 97338-03-9 «thyl (S)-3-(4-aminophenyl)-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 (1-cyanocyclohexyl)acetate 123632-23-5 4-(2,2,3,3 -tetrafluoropropoxy)cinnamon!trile 2328 00 90 94213-23-7 (Z)-[cyano(2,3- 2930 90 16 159453-24-4 N-(benzyloxycarbanyl)-S-phenyl-L-cysteine 2930 90 70 159878-02-1 benzyl (1R,2S)-3-chloro-2-hydroxy-l- dichlorophenyl)methylene]carbazamidine (phenylthiomethyl)propylcarbamate 136511-43-8 ethyl N-{2-[(acetylthio)methyl]-3-(o-tolyl)-1- oxopropyl}-L-methionate 2932 19 00 2932 29 80 97148-39-5 ammonium (Z)-2-methoxyimino-2-(2-furyl)acetate 517-23-7 alpha-acetyl-gamma-butyrolactone 6559-91-7 4'-demethylepipodophyllotoxin 3 9521-49-8 (3aR,4bS,4R,4aS,5aS)-4-(5,5-dimethyl-1,3- 2932 99 50 2932 99 70 dioxolan-2- yl)hexahydrocyclopropa[3,4]cyclopenta[1,2- b]furan-2(3H)-one 39746-Q1-5 (3aR, 4R, 5R, 6aS) -4-formyl-2-oxohaxahydro-2H- cyclopenta[b]furan-5-yl benzoate 976-70-5 3-oxopregn-4-ene-21,17-alpha-carbolactone 32981-86-5 ia-deacetylbaccatin III 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-i,3-dioxolan-4-yl]acetate 467-55-0 3-beta-hydroxy-5 -alpha-epiro3tan-12-one 533-31-3 3,4-(methylenedioxy)phenol 4t CM code CAS RM Nana 2933 11 90 6150-97-6 magnesium bis[(2,3-dihydro-l, 5-dimethyl-3-oxo- ANNEX II 2-phenyl-IH-pyrazol-4 - yl)methylamino]methanesulfonate 27511-79-1 3-aminopyrazole-4-carbaxamide hemisulfate 2933 19 90 2933 29 90 2933 39 95 142057-79-2 (RS)-2-[(l-benzyl-4-piperidyl)methyl]-5,6- 4897-25-0 5~chloro-l-methyl-4-nitroimidazale 120014-07-5 2-[(l-benzyl-4-piperidyl)methylene]-5,6- dimethoxyindan-l-one dimethoxyindan-1-one 6 935-27-9 benzyl(2-pyridyl)amine 2933 39 95 87848-95-1 6-bromo-2-pyridyl p-tolyl ketone 32998-95-1 N-(tert-butyl)-3-methylpyridina-2-carboxamide 84449-80-9 1-[2-(4-carboxyphenoxy)ethyl]piperidinium chloride 83949-32-0 4-carboxy-4-phenylpiperidinium p- coluenesulfonate 38092-89-6 8-chloro-6,ll-dihydro-11-(l-methyl-4- piperidylidene)-SH-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 108555-2S-5 1-[2-(4-methoxyphenyl)ethyl]-4-piperidylamine dihydrochloride 4046-24-6 5-(l-methyl-4-piperidyl)-5H- 139886-0^-7 1-methyl-l,2,5,6-t«trahydropyridine-3-' dibenzo[a,d]cyclohepten-5-ol hydrochloride 70708-28-0 1-(2-pyridyl)-3-(pyrrolidin-1-yl)-1-(p- carbaldehyde (E)-O-methyloxime hydrochloride tolyl)propan-l-ol 1619-34-7 quinuclidin-3-ol 2933 40 10 1059S6-96-5 7-[3-{tert-butoxycarbonylamino)pyrrolidin-1- yl]-8-chloro-l-cyclopropyl-6-fluoro-4-oxo-l,4- dihydroguinoline-3-carboxylic acid 86393-33-1 7-chloro-1-cyclopropy1-6-f1uoro-4 -oxo-1,4- dihydroquinoline-3-carboxylic acid H2811-72-0 l-cyclopropyl-6,7-difluoro-B-methoxy-4-oxo- 1,4-dihydroquinoline-3-carboxylic acid 98349-25-8 ethyl 1-cyclopropyl-6,7-difluoro-4-oxo-l,4- dihydroquinoline- 3 -carboxylate 2933 40 90 159878-04-3 benzyl (IS,2B)-3- [ (3S,4aS,8aS)-3-tert- butylcarbamoylperhydro-2-isoguinolyl]-2- hydroxy-1-(phenylthiomethyl)propylcarbamate 15 9989-64-7 (3S,4aS,8aS)-N-(tert-butyl)-2-[(2S,3S}-2- hydroxy-3- (3-hydraxy-2~methylbe. nzamido) -4- (phenylthio)butyl]perhydroisoquinaline-3- carboxarnide 15 998 9-65-8 (3S,4aS,8aS)-N-(tert-butyl)-2-[(2S,3S)-2- hydroxy-3-(3-hydroxy-2-methylbenzamido)-4- (phenylthio)butyl]perhydroisoquinoline-3- carboxamide--methane8Ulfonic acid (1:1) 120578-03-2 3-'[ (E) - 2 - (7 -chloro-2- quinolyl)vinyl]benzaldehyde 15 ANNEX II CM code CAS RM H*»« 1087-69-0 (9S,13S,14S)-3-methoxymorphinan hydrochloride 64228-78-0 pent ante thyl ene bis{3-[i-(3,4-dimethoxybenzyl)- 6,7-dimathoxy-i,2,3,4-tetrahydro-2- isoquinolyl]propionate}--oxalic acid (1:2) 2933 59 70 75128-73-3 2-[(2-acetamido-6-0x0-6,9-dihydro-lH-purin-9- yDmethoxy] ethyl acetate 3056-33-5 N- (9-acetyl-6-oxo-6,9-dihydro-lH-purin-2- 10310-21-1 2-amino-6-chloropurine yl)acetamide 124832-31-1 2-[(2-amino-6-oxo-l,6-dihydro-9H-purin-9- yl)methoxy]ethyl N-(benzyloxycarboayl)-L- valinate 150378-17-9 (2R,4S)-2-benzyl-5-[2-(tert-butylcarbamoyl)-4- (3-pyridylmethyl)piperaz in-1-yl]- 4 -hydroxy-N- [ (1S. 2R)-2-hydroxyindan-l-yl]valeramida 2933 59 70 157810-81-6 (2R,4S)-2-benzyl-5-[2-(tert-butylcarbamoyl)-4- (3-pyridylmethyl)piperazin-l-yl]-4-hydroxy-N- [(IS,2R)-2-hydroxyindan-1-yl]valeramide sulfate 150323-35-6 (3S)-1-(tert-butoxycarbonyl)-3-(tert- butyl carbamoyl)pipera z ine 41202-32-8 <l-(2-chlorophenyl)piperazine hydrochloride 13078-15-4 1-(3-chlorophenyl)piperazine hydrochloride 71-30-7 cytoaine 149062-75-9 1,3-dlchlorO-6,7,8,9,10, 12- hexahydroazepino[2,l-b]quinazoline hydrochloride ,41202-77-1 1-(2, 3-dichlorophenyl)piperazine hydrochloride 56177-80-1 2-ethoxy-5-fluorapyrimidin-4(1H)-one 112733-45-6 ethyl (7-chloro-2,4-dioxo-l, 2 , 3 , 4- 59703-00-3 4-ethyl-2,3-dioxopiperazine-l-carbonyl tetrahydroquinazolin-1-yl)acetate chloride 64090-19-3 1-(4-fluorophenyl)piperazine dihydrochloride 147539-21-7 i3opropyl[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-phenylpiperaziniura chloride 111641-17-9 4-(piperazin-1-yl)-2,6-bia(pyrrolidin-I- yl)pyrimxdine 68-94-0 purin-6(1H)-one 2933 69 80 70849-60-4 1-(o-tolyl)piperazine hydrochloride 58909-39-0 tetrahydro-2-methyl-3-thioxo-l,2,4-criazine- 2933 79 00 135297-22-2 (3S,4R)-3-[(R)-1-(tert- 5. 6-dione butyldimethylsilyloxy)ethyl]-4-[(lR,3S)-3- methoxy-2-oxocyclohexyl]azetidin-2-one 141646-08-4 l-{[(cyclohexyloxy)carbonyl]oxy}ethyl l-(l- hydroxyethyl)- 5-methoxy-2-oxo- 1,2,5,6,7,8,8a,8b-octahydroazeto[2,1- a]isoindale-4-carboxylate 132127-34-5 (3R,4S)-3-hydroxy-4-phenylazetidin-2-one 75363-99-4 p-nitrobenzyl (2R. 5R,6S)-6-[(R)-l- hydroxyethyl]-3,7-dioxo-l- ANNEX II CM code CAS RM 141316-45-2 potassium l-(1-hydroxyethyl)-5-raethoxy-2-oxo- azabicyclo[3. 2. o] hop tane-2-car boxy late 1,2,5,6,7,8,8a,8b-octahydroazeto[2,1- a]isoindole-4-carboxylate 2933 90 60 59467-64-0 [7-chloro-5-(2-fluorophenyl)-2,3-dihydro-lH- 59469-29-3 [7-chloro-5-(2-fluorophenyl)-2,3-dihydro-lH- 1,4-benzodiazepin-2-yl]methylamine l,4-benzodiazepin-2-ylmethyl]ammonium bis(maleate) 59467-69-5 8-chloro-6-(2-fluorophenyl)-l-methyl-3a,4- dihydro-3H-imidazo[l', 5-a] [1, 4] benzodiazepine 5946 9-63-5 7-chloro-5-(2-fluorophenyl)-3-methyl-2- (nitromethylene)-2,3-dihydro-lH-l,4- benzodiazepine 4-oxide 59467-63-9 7-chloro-5-(2-fluorophenyl)-2- (nitromethylene)-2,3-dihydro-lH-l, 4- benzodiazapine 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--i-deoxy-l- methylamino-D-glucitol (1:1) 122536-48-5 3-[(S)-3-(L-alanylamino)pyrrolidin-i-yl]-i- cyclopropyl-6-fluoro-4-oxo-l, 4-dihydro-l,8- naphthyridine-3-carboxylic acid hydrochloride 122536-91-8 7-{(S)-3-[(S)-2-(tert-butoxycarbonylamino)-l- oxopropylamino]pyrrolidin-1-yl}-l-cyclopropyl- 6-fluoro-4-oxo-l,4-dihydro-l,8-naphthyridine- 3-carboxylic acid 134575-17-0 tert-butyl meso-3-azabicyclo[3. 1. 0]hex-6- 122536-66-7 tert-butyl { (S) -l-methyl-2-oxo-2- [ (S) -1 ylcarbamate pyrrolidin-3-ylamino]ethyl}carbamate 140629-77-2 tert-butyl [(RS)-pyrrolidin-3-yl]carbamate 100361-18-0 7-chloro-l-cyclopropyl-6-fluoro-4-oxo-l,4- 38150-27-5 S-chloro-2-[3-(hydroxymethyl)-5-methyl-4H- dihydro-1,8-naphthyridine-3-carhoxylic acid 1,2,4-triazol-4-yl]benzophenone 36916-19-5 5-chloro-2- (3r-methyl-4H-l, 2 ,4-triazol-4- yl )benzophenone 54196-62-2 2' , 5-dichloro-2- [3- (hydroxymethyl) -5-mathyl- 4H-1,2,4-triazol-4-yl]benzophenone 54196-61-1 2',5-dichloro-2-(3-methyl-4H-1,2,4-triazol-4- 141113-28-2 (E)-(+)-2-(2,4-difluorophenyl)-l-{3-[4- yl)benzophenone (2,2,3,3-tecrafluoropropoxy)styryl]-1H-1,2,4- triazol-i~yl}-3-(1H-1,2,4-triazol-l-yl)propan • 2-ol 141113-41-9 (R)-2-(2,4-difluorophenyl)-3-(1H-1, 2,4- triazol-l-yl)propane-l,2-diol 144034-80-0 dimethyl{2-[5-(1H-1,2,4-triazol-1- 122665-86-5 ethyl [3-(cyanomechyl)-4-oxo-3, 4- ylmethyl)indol-3-yl]ethyl)amine dihydrophthalazin-l-yl]acetate 41340-36-7 2-(7-ethyl-iH-indol-3-yl)'ethanol 95885-13-5 5-ethyl-4- (2-phenoxyethyl)-4H-1, 2. 4»triazol- ^ ANNEX II CM coda CAS RN Name 3 (2H) -one 96107-94-7 ethyl 1H-tetrazole-5-carboxylate, sodium salt 96034-57-0 trans-4-hydroxy-i-(4-nitrobenzyloxycarbonyl)- L-proline 160194-26-3 2-iodo-4-(1H-1,2. 4-triazol-l-ylmethyl)aniline 66635-71-0 isopropyl 2,3-dihydro-lH-pyrrolizine-l- carboxylate 4928-88-5 methyl 1H-1,2,4-triazole-3-carboxylate 0-00-0 1,4,7,10-tetraazacyclododecane-i,4,7-triacetic acid sulfate 112193-77-8 1,4,7,10-tetraazoniacyclododecane bis(sulfate) —• —; 3641-08-5 lH-l,2,4-triazole-3-carboxaroide 4928-87-4 1H-1,2. 4-triazole-3-carboxylic acid 6969-71-7 l,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)phénoxymethyl]-2,5,7,8- tetramethylchroman-6-yl acetate 65872-41-5 (Z)-2-(2-aminothiazol-4-yl)-2- methoxyiminoacetic acid 64486-18-6 (2)-2-[2-(chloroacetamido)thiazol-4-yl]-2- 76823-93-3 1-{4-[(2-cyanoethyl)thiomethyl]thiazol-2- (mechoxyimino)acetic acid yl}guanidine 2934 10 00 139340-56-0 (S-[(Z)-3,S-di(tert-butyl)-4- hydroxybenzylidene]-4-oxo-4,5-dihydrothiazol- 2-yl}ammonium methanesulfonate 64485-88-7 ethyl (Z)-2-(2-aminothiazol-4-yl)-2 - 66339-00-2 ethyl 2-(hydroxyimino)-2-[2- (methoxyimino)acetate (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- 154212-59-6 4-nitrophenyl thiazol-5-ylmethyi carbonate 4-yl]acetic acid hydrochloride 38585-74-9 thiazol-5-ylmethanol 155213-67-5 thiazol-5-ylmethyl (IS,2S,4S)-l-benzyl-2- hydroxy-4-{(2S)-2-[3-(2-iaopropylthia2ol-4- ylmethyl) -3-methylureido] -3-methylbuty*;avnido} - 5-phenylpentylcarbamate 2934 20 50 80756-85-0 S- (benzothiazol-2-yl) (Z)-2- (2-aminotbi-(sol-4- yl)-2-methoxyiminothioacetate 2934 20 90 87691-88-1 1-(I,2-bensisothiazdl-3-yl)piperazine hydrochloride 2934. 30 50 111974-69-7 2-(2-[4-(dibenzo [b, f ] [l, 4) thiazepin-i:5- yl) piperazin-1-yl] ethaxy}atha. nol 42399-49-5 (3S, 3S) - 3 - hydroxy - 2 - (4-methoxyphenyl) •". ^ dihydro-l,5-benzothiazepin-4(5H)-on® 2934 90 60 115787-67-2 2 » (2-amino-5-nltro-6-oxo-l, 6-dihydropyr : ' ixdi. n- 4-yl) -3- (3-thienyl)propionon. itrile 117829-20-6 2~amino~7-thenyl-i,7-dihydro-4H-pyrraXoD(3~ d]pyrimidin-4. -one hydrochloride 1 CM coda CAS RM Nam* ANNEX n 112887-68-0 N-{5-[(1,4-dihydro-2-mcthyl-4-oxoquinazolin-6- ylmethyl)methylamino]-2-thenoyl}-L-glutamic acid 161005-84-1 (S)-N,N-dimethyl-[3-(2-thienyl)-3-(l- naphthyloxy)propyl]amine--phosphoric acid (1:1) 104795-66-6 3-isopropoxy-5-methoxy-N-(lH-tetrazol-5- yl)benzo[b]thiophene-2-carboxamide 104795-67-7 3-isopropoxy-5-methoxy-N-(lH-tetrazol-5- yl)benzo[b]thiophene-2-carboxamide--lH- imidazole (1:1) 104795-68-8 3-iaopropoxy-5-methoxy-N-(lH-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- 2934 90 70 2934 90 80 119221-49-7 5-[(2-aminoethyl)amino]-2-(2- 25229-97-4 2-cyano-3-morpholinoacrylamide carbonitrile diethylaminoethyl)-2H- (l]benzothiopyrano[4,3,2-cd]indazol-8-ol 147086-81-5 (43. 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-(aulforaethyl)-lH-tetrazol-5- ylthiomethyl]-3-cepham-4-carboxylic acid, sodium salt 2934 90 98 29706-84-1 3•' -azido-3 ' -deoxy-5 ' -O-tritylthymidine 51762-51-7 benzhydryl 3-hydroxy-7- 110314-42-6 5-[(benzofuran-2-ylcarbonyl)amino]indole-2- (phenylacetamido)cepham-4-carboxylate carboxylic acid 131986-28-2 3- (4-chloro-l,2, 5-thiadiazol-3-yl)pyridine 107452-89-1 omega-conotoxin M VIIA 126429-09-2 2-(dichloromethyl)-4,5-dihydro-5-(4- meaylphenyl)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)-lH-indol-5- yl]methyl}oxazolidin-2-one 110351-94-5 (S) -4-ethyl-4,-hydroxy-7,8-dihydro-lH- pyrano[3,4-f]indolizine-3,6,10(4H)-trione 140841-32-3 6- [3-fluora-5-(4-methoxytetrahydropyran-4- 94732-98-6 1-(l-{3-[2-(4-fluorophenyl)-1,3-dioxolan-2- yl)phenoxymethyl]-l-methyl-2-quinolone yl]propyl}-4-piperidyl)-2,3-dihydro-lH- benzimidazole-2-thione 125935-03-1 (4R,6R)-G-{2- [2-(4-fluorophenyl)-5-isopropyl- 3-phenyl-4-(phenylcarbamoyl)pyrrol-1 - yl]ethyl}-4-hydroxytetrahydro-2H-pyran-2-one 131988,-19-7 3- (4-hexyloxy-l,2. S-thiadiazol-3-yl! -1- methylpyridinium iodide 147027-10-9 (1R,2S,5R)-menthyl (2R,5S)-5-(4-amino-2-oxo- l, 2-dihydropyrimidin-l-yl)-1,3-oxathiolane-2- CM c o de CAS RM Mane ANNEX II 147126-62-3 104218-44-2 27255-72-7 0-00-0 32231-06-4 55612-11-8 2935 00 90 151140-66-8 112101-81-2 120298-38-6 1S0975-9S-4 84522-34-9 2939 10 00 2940 00 90 3824 90 64 66820-84-6 13035-61-5 330-95-0 104832-01-1 0-00-0 3824 90 64 0-00-0 0-00-0 0-00-0 3824 90 95 3911 90 3913 90 80 0-00-0 162430-94-6 83513-48-8 carboxylate (1R,2S,5R)-menthyl (2R,5R)-5-hydroxy-1,3- oxathiolane-2-carboxylate 3'-0-mesyl-5'-O-tritylthymidine 3-methyl-7-(phenylacetamido)-3-cephem-4- carboxylic acid (1R,2S,3S,6R)-[(S)-l-phenylethyl]-3. 6- epoxyt et rahydrophtha1imide 1-piperonylpiperaziiMS 5 *-O-tritylthymidine (4-amino-3-iodophenyl)-N- methylmethanesulfonamide 5-[(R)-(2-aminopropyl)]-2- methoxybenzeneaulfonamide N-(5,6-dihydro-6-methyl-2-sulfamoyl-4H~ thieno[2,3-b]thiopyran-4-yl)acetamide 7,7- dioxide 5-methanesulfonamidoindole-2-carboxy1ic acid sodium 4-[2-(5-methylpyrazine-2- carboxamido)ethyl]benzenesulfonamide (RS)-tetrahydropapaverine hydrochloride 1,2. 3,5-tetraacetyl-beta-D-ribofuranose 1,3-bis(4-nitrophenyl)urea- -4,6- dimathylpyrimidin-2-ol (1:1) (R)-6,7-dimethoxy-2-methyl-1-(3,4,5- trimethoxybenzyl)-1,2, 3,4- tetrahydroisoquinoline--dibenzoyl-L-tartaric acid (1:1) 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 Mo. 3002 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. 3002 Intermediate concentrates obtained from a Micromonospora inyoensis fermentation medium used for the manufacture of the antibiotics sisomiein (INN) and netilmicin (INN) Intermediate concentrates obtained from a Micromonospora purpurea fermentation medium used for the manufacture of the antibiotics gentaraicin sulfate (ÏNNM) and isepamicin (INN) ethyl 7-chloro-2-oxoheptanoate, in the form of a solution in toluene 1,6-hexanediamine, polymer with 1,10- dibromodecane danaparoid sodium c2o Annex III Additions to the list of prefixes and suffixes which, in combination with the INNs, describe salts, esters or hydrates of INNs. 51 ACETURATE N-ACETYLGLYCINATE ACISTRATE ACOXIL AMSONATE BENZATHINE BEZOMIL BUCICLATE BUNAPSILATE BUTEPRATE BUTYL ESTER CARBESILATE p-CHLOROBENZENESULFONATE p-CHLOROBENZENESULPHONATE CICLOTATE CIPIONATE CLOSILATE CLOS YL ATE CROBEFATE CROMACATE CROMESILATE CYCLOPENTANEPROPIONATE CYCLOTATE CYPIONATE DAPROPATE DEANIL DECIL DIBUDINATE DIBUNATE DIETHANOLAMINE DIGOLIL N,N-DIMETHYL-beta-ALANINE DIOLAMINE DOCOSEL 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 n PIVOXETIL PROXETIL 1 -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 2903 30 10 2903 51 10 2906 21 00 2915 29 00 2922 41 00 2922 42 90 2922 49 10 2922 50 00 2923 10 10 2928 00 90 2930 90 20 2933 90 95 3102 70 10 3904 61 10 3906 90 90 3907 20 3907 20 12 3907 20 21 3907 60 10 3908 10 00 3910 00 00 3912 20 11 3912 31 00 3912 39 80 79-01-6 811-97-2 58-89-9 100-51-6 82279-57-0 56-87-1 56-86-0 56-40-6 72-19-5 67-48-1 79-17-4 111-48-8 73-22-3 156-62-7 9002-84-0 54182-57-9 0-00-0 25322-68-3 25301-02-4 25038-59-9 25038-54-4 9006-65-9 9004-70-0 9000-11-7 8063-82-9 trichloroethylene norflurane lindane benzyl alcohol zinc acetate, basic lysine glutamic acid glycine threonine choline chloride pimagedine thiodiglycol tryptophan calcium carbimide politef carbomer macrogol ester macrogol tyloxapol pegoterate policapram dimeticone pyroxylin carmellose hypromellose l\ ISSN 0254-1475 COM(96) 563 final DOCUMENTS EN 02 05 09 15 Catalogue number : CB-C0-96-562-EN-C ISBN 92-78-10884-7 Office for Official Publications of the European Communities L-2985 Luxembourg 25