EUROPEAN UNION

THE EUROPEAN PARLIAMENT THE COUNCIL

Brussels, 29 November 2010 (OR. en)

2010/0214 (COD) PE-CONS 59/10

WTO 353 UD 292 CODEC 1167

LEGISLATIVE ACTS AND OTHER INSTRUMENTS Subject: REGULATIONOFTHEEUROPEANPARLIAMENTANDOF THECOUNCILamendingAnnexItoCouncilRegulation(EEC) No2658/87asregardstheprovisionofdutyfreetreatmentforspecified pharmaceuticalactiveingredientsbearingan"international nonproprietaryname"(INN)fromtheWorldHealthOrganizationand specifiedproductsusedforthemanufactureoffinishedpharmaceuticals

PECONS59/10 NC/kp DGDDTE EN REGULATION (EU) No .../2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of

amending Annex I to Council Regulation (EEC) No 2658/87 as regards the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an "international non-proprietary name" (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals

THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,

HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,andinparticular Article207thereof,

HavingregardtotheproposalfromtheEuropeanCommission,

Aftertransmissionofthedraftlegislativeacttothenationalparliaments,

Actinginaccordancewiththeordinarylegislativeprocedure 1,

1 PositionoftheEuropeanParliamentof23November2010(notyetpublishedintheOfficial Journal)anddecisionoftheCouncilof.... PECONS59/10 NC/kp 1 DGDDTE EN Whereas:

(1) InthecourseoftheUruguayRoundnegotiations,theCommunityandanumberof countriesagreedthatdutyfreetreatmentshouldbegrantedtopharmaceuticalproducts fallingwithintheHarmonisedSystem(HS)Chapter30andHSheadings2936,2937,2939 and2941aswellastodesignatedpharmaceuticalactiveingredientsbearingan "internationalnonproprietaryname"(INN)fromtheWorldHealthOrganization,specified salts,estersandhydratesofsuchINNs,anddesignatedpharmaceuticalintermediatesused fortheproductionandmanufactureoffinishedpharmaceuticals.

(2) Theresultsofthediscussions,assetoutintheRecordofDiscussions,wereincorporated intothetariffschedulesoftheparticipantsannexedtotheMarrakeshProtocoltothe GeneralAgreementonTariffsandTrade(GATT)1994.

(3) ParticipantsconcludedthatrepresentativesofWorldTradeOrganization(WTO)members, partytotheRecordofDiscussions,wouldmeetundertheauspicesoftheCouncilforTrade inGoodsoftheWTO,normallyatleastonceeverythreeyears,toreviewtheproduct coveragewithaviewtoincluding,byconsensus,additionalpharmaceuticalproductsfor tariffelimination.

(4) Threesuchreviewshavetakenplacewiththeresultthatacertainnumberofadditional INNsandpharmaceuticalintermediatesusedfortheproductionandmanufactureof finishedpharmaceuticalshavebeengranteddutyfreetreatment,thatsomeofthose intermediateshavebeentransferredtothelistofINNs,andthatthelistofspecified prefixesandsuffixesforsalts,estersorhydratesofINNshasbeenexpanded.

PECONS59/10 NC/kp 2 DGDDTE EN (5) Afourthreviewwasdeemedappropriateandwaslaunchedin2009.Itconcludedthata certainnumberofadditionalINNsandpharmaceuticalintermediatesusedforthe productionandmanufactureoffinishedpharmaceuticalsshouldbegranteddutyfree treatment,thatsomeofthoseintermediatesalreadyincludedinthepharmaceuticalsectoral arrangementanditsrevisionsshouldbetransferredtothelistofINNs,andthatthelistof specifiedprefixesandsuffixesforsalts,estersorhydratesofINNsshouldbeexpanded.

(6) CouncilRegulation(EEC)No2658/87of23July1987onthetariffandstatistical nomenclatureandontheCommonCustomsTariff 1establishedtheCombined Nomenclature(CN)andsetouttheconventionaldutyratesoftheCommon CustomsTariff.

(7) Regulation(EEC)No2658/87shouldthereforebeamendedaccordingly.

(8) InordertoensurethatthemeasuresprovidedforinthisRegulationapply from1January2011,itshouldenterintoforceonthedayfollowingthatofitspublication,

HAVEADOPTEDTHISREGULATION:

1 OJL256,7.9.1987,p.1. PECONS59/10 NC/kp 3 DGDDTE EN Article 1

Annexes3,4and6ofSectionIIofPartThreeofAnnexItoRegulation(EEC)No2658/87(Listsof pharmaceuticalsubstanceswhichqualifyfordutyfreetreatment)areherebyamendedasfollows:

(1) Asfrom1January2011theUnionshallextenddutyfreetreatmenttotheINNslisted inAnnexI.

(2) Asfrom1January2011thelistofprefixesandsuffixeswhich,incombinationwiththe INNsincludedinthepharmaceuticalsectoralarrangementanditsrevisions,describethe salts,estersorhydratesofINNswhicharealsoeligiblefordutyfreetreatment,on conditionthattheyareclassifiableinthesamesixdigitHSsubheadingasthe correspondingINN,shallbeamendedassetoutinAnnexII.

(3) Asfrom1January2011theUnionshallextenddutyfreetreatmenttothepharmaceutical intermediatesusedintheproductionandmanufactureoffinishedpharmaceuticals,listed inAnnexIII.

(4) Asfrom1January2011thepharmaceuticalintermediateslistedinAnnexIVshallbe withdrawnfromthelistofsuchcompoundsreceivingdutyfreetreatment.

PECONS59/10 NC/kp 4 DGDDTE EN Article 2

ThisRegulationshallenterintoforceonthedayfollowingthatofitspublicationinthe Official Journal of the European Union .

Itshallapplyfrom1January2011.

ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinallMemberStates.

Doneat,

For the European Parliament For the Council The President The President

PECONS59/10 NC/kp 5 DGDDTE EN ANNEX I

List of international non-proprietary names (INNs) to be added to the list of products receiving duty-free treatment included in Annex 3 to Annex I to Regulation (EEC) No 2658/87

CNcode CASRN Name 28429080 119175483 fermagate 28439090 759457824 padeliporfin 28444030 123748561 iodofilticacid( 123 I) 29041000 21668779 eprodisate 29061900 199798840 elocalcitol 29093090 24150241 terameprocol 29161995 81485258 peretinoin 29163900 51543409 tarenflurbil 29181998 174022425 bevirimat 29199000 258516891 fospropofol 29209085 163133435 naproxcinod 29211999 3687181 tramiprosate 29221985 68392358 afimoxifene 29221985 753449671 ronacaleret 29222900 433265657 faxeladol 29225000 121524081 amibegron 29225000 329773355 cinaciguat 29225000 643094499 fasobegron 29231000 856676238 cholinefenofibrate 29242998 847353304 arbaclofenplacarbil

PECONS59/10 NC/kp 1 ANNEXI DGDDTE EN CNcode CASRN Name 29242998 194785198 bedoradrine 29242998 194085751 carisbamate 29242998 254750022 emricasan 29242998 355129156 eprotirome 29242998 402567162 firategrast 29242998 478296729 enacarbil 29242998 15866907 incyclinide 29242998 202844108 indantadol 29242998 96847551 levomilnacipran 29242998 608137322 lisdexamfetamine 29242998 652990073 milveterol 29242998 181816488 ombrabulin 29242998 289656457 senicapoc 29251995 19171198 pomalidomide 29280090 22033870 olesoxime 29280090 2675356 sivifene 29280090 816458318 tecovirimat 29280090 238750771 tosedostat 29280090 149647789 vorinostat 29299000 31645393 palifosfamide 29309099 608141419 apremilast 29309099 216167929 camobucol 29309099 211513370 dalcetrapib 29309099 69819869 darinaparsin 29309099 488832695 elesclomol

PECONS59/10 NC/kp 2 ANNEXI DGDDTE EN CNcode CASRN Name 29309099 216167952 elsibucol 29309099 168682539 ezatiostat 29309099 58569554 metenkefalin 29309099 887148698 monepantel 29309099 603139191 odanacatib 29309099 162520005 salirasib 29309099 216167827 succinobucol 29309099 125961822 tipelukast 29310099 125973560 amsilarotene 29321900 253128415 eribulin 29321900 186953560 pafuramidine 29322985 195883068 omtriptolide 29329900 664338390 arterolane 29329900 183133962 cabazitaxel 29329900 401925437 celivarone 29329900 461432268 dapagliflozin 29329900 118457151 dexnebivolol 29329900 156294369 larotaxel 29329900 118457162 levonebivolol 29329900 83461567 mifamurtide 29329900 117570533 vadimezan 29331990 496775612 eltrombopag 29331990 206884982 niraxostat 29331990 410528028 palovarotene 29331990 376592426 totrombopag

PECONS59/10 NC/kp 3 ANNEXI DGDDTE EN CNcode CASRN Name 29332990 183659725 catramilast 29332990 944263654 demiditraz 29332990 867153615 dulanermin 29332990 320367133 lixisenatide 29332990 698389003 rolipoltide 29332990 697766759 velafermin 29333999 147084104 alcaftadine 29333999 54966 29333999 249921195 anamorelin 29333999 319460850 axitinib 29333999 208110649 befiradol 29333999 330942057 betrixaban 29333999 201034755 daporinad 29333999 209783802 entinostat 29333999 412950277 goxalapladib

29333999 218791210 imisopasemmanganese

29333999 103129824 29333999 154357423 levonadifloxacin 29333999 108147542 migalastat 29333999 453562691 motesanib 29333999 139145270 parogrelil 29333999 459856189 pexacerfont 29333999 706779911 pimavanserin 29333999 362665563 pitolisant 29333999 861151124 rosonabant

PECONS59/10 NC/kp 4 ANNEXI DGDDTE EN CNcode CASRN Name 29333999 701977095 taranabant 29333999 189950116 tropantiol 29333999 793655648 vapitadine 29333999 139290656 volinaserin

29334990 141388763 besifloxacin

29334990 697761981 elvitegravir

29334990 185055678 ferroquine

29334990 445041758 intiquinatine

29334990 378746646 nemonoxacin

29334990 245765417 ozenoxacin

29334990 412950084 rilapladib

29334990 871224645 almorexant 29334990 863029996 balamapimod 29334990 698387096 neratinib 29334990 154652832 tezampanel 29334990 128253316 veliflapon 29335995 791828585 aderbasib 29335995 840486933 adipiplon 29335995 850649615 alogliptin 29335995 859212161 bafetinib 29335995 380843754 bosutinib 29335995 839712128 cariprazine

PECONS59/10 NC/kp 5 ANNEXI DGDDTE EN CNcode CASRN Name 29335995 414910273 casopitant 29335995 288383200 cediranib 29335995 849550056 cevipabulin 29335995 827318978 danusertib 29335995 356057346 darapladib 29335995 501000368 dutacatib 29335995 247257483 fimasartan 29335995 3432993 folitixorin 29335995 668270120 linagliptin 29335995 441798330 macitentan 29335995 641571100 nilotinib 29335995 763113220 olaparib 29335995 686344296 otenabant 29335995 625115551 riociguat 29335995 486460326 sitagliptin 29335995 425637189 sotrastaurin 29335995 309913835 talmapimod 29335995 113857877 talotrexin 29335995 274693275 ticagrelor 29335995 306296479 vicriviroc 29336980 775351650 imeglimin 29337900 461443594 aplaviroc 29337900 189691063 bremelanotide 29337900 813452185 carmegliptin 29337900 405169166 dovitinib

PECONS59/10 NC/kp 6 ANNEXI DGDDTE EN CNcode CASRN Name 29337900 536748466 eribaxaban 29337900 473289622 ilepatril 29337900 180694977 mimopezil 29337900 579475186 orvepitant 29337900 449811012 pamapimod 29337900 248282011 paquinimod 29337900 380917975 perampanel 29337900 552292087 rolapitant 29337900 425386603 semagacestat 29337900 515814014 voclosporin 29339980 481629872 aleplasinin 29339980 394730600 boceprevir 29339980 649735637 brivanibalaninate 29339980 483369580 denagliptin 29339980 284019347 denibulin 29339980 481631452 diaplasinin 29339980 272105427 disitertide 29339980 227318710 epetirimod 29339980 259793969 favipiravir 29339980 871576033 flovagatran 29339980 229305399 golotimod 29339980 258818347 larazotide 29339980 571170779 laropiprant 29339980 616202927 lorcaserin 29339980 868771577 melogliptin

PECONS59/10 NC/kp 7 ANNEXI DGDDTE EN CNcode CASRN Name 29339980 803712676 obatoclax 29339980 404950807 panobinostat 29339980 625114412 piragliatin 29339980 74847351 pyronaridine 29339980 872178659 rabeximod 29339980 355151121 rotigaptide 29339980 497221382 rusalatide 29339980 187602115 sofigatran 29339980 227318754 sotirimod 29339980 402957282 telaprevir 29339980 848084833 tigapotide 29339980 393105538 tiplasinin 29339980 620948938 vabicaserin 29339980 794466709 29341000 544417405 capadenoson 29341000 302962498 dasatinib 29341000 223132374 inolitazone 29341000 241479674 isavuconazole

29341000 338990844 isavuconazoniumchloride

29341000 607723331 lobeglitazone 29341000 280782970 managlinatdialanetil 29341000 790299795 masitinib 29341000 223673618 mirabegron 29341000 501948056 rosabulin 29341000 447406782 sodelglitazar

PECONS59/10 NC/kp 8 ANNEXI DGDDTE EN CNcode CASRN Name 29341000 760937926 teneligliptin 29342080 848344365 bentamapimod 29342080 870093235 talarozole 29349990 320345991 aclidiniumbromide 29349990 222551179 adoprazine 29349990 207623209 agatolimod 29349990 475479346 aleglitazar

29349990 870524462 amolimogenebepiplasmid

29349990 875446370 anacetrapib 29349990 250386153 apadenoson 29349990 541550190 apilimod 29349990 160707697 apricitabine 29349990 147403030 azilsartan 29349990 863031214 azilsartanmedoxomil 29349990 757942431 bederocin

29349990 627861078 beperminogeneperplasmid

29349990 959961967 bevasiranib 29349990 769901964 capeserod 29349990 868540174 carfilzomib 29349990 872847660 cenersen 29349990 80295381 conestatalfa 29349990 903916278 custirsen 29349990 187865221 derquantel 29349990 134379774 dexelvucitabine

PECONS59/10 NC/kp 9 ANNEXI DGDDTE EN CNcode CASRN Name 29349990 247046522 dilopetine 29349990 480449705 edoxaban 29349990 188181422 elacytarabine 29349990 98819762 esreboxetine 29349990 763903679 fosalvudinetidoxil 29349990 172673200 fosaprepitant 29349990 522664637 ibodutant

29349990 405159593 idrabiotaparinuxsodium

29349990 188116076 29349990 335619186 inakalant 29349990 1391362 lancovutide 29349990 189059710 lapaquistat 29349990 327026937 lensiprazine 29349990 170632470 lificiguat 29349990 852313258 litenimod 29349990 1000120988 mipomersen 29349990 62253638 nepidermin

29349990 26833874 omacetaxinemepesuccinate

29349990 269718845 pardoprunox 29349990 219923850 pramiconazole 29349990 377727872 preladenant 29349990 524684524 prinaberel 29349990 865311473 quarfloxin 29349990 869884786 radezolid

PECONS59/10 NC/kp 10 ANNEXI DGDDTE EN CNcode CASRN Name 29349990 496054876 radiprodil 29349990 518048050 raltegravir 29349990 787548032 regrelor 29349990 820957388 retosiban 29349990 572924540 ridaforolimus 29349990 128517077 romidepsin 29349990 93265817 ropidoxuridine 29349990 151823142 sapacitabine 29349990 379231046 saracatinib 29349990 791635591 simotaxel 29349990 119567792 taribavirin 29349990 332012405 telatinib 29349990 925681614 trabedersen 29349990 189003927 trelanserin 29349990 296251724 velimogenealiplasmid 29349990 904302983 viquidacin 29349990 872525616 votucalis 29349990 221877549 zotarolimus 29350090 197904840 apricoxib 29350090 769169279 begacestat 29350090 414864009 belinostat 29350090 313682085 brecanavir 29350090 839673528 cevoglitazar 29350090 358970975 drinabant 29350090 865200200 giripladib

PECONS59/10 NC/kp 11 ANNEXI DGDDTE EN CNcode CASRN Name 29350090 464213103 ibipinabant 29350090 173424776 laromustine 29350090 398507556 lodenafilcarbonate 29350090 136564686 masilukast 29350090 170569887 mavacoxib 29350090 862189955 mirodenafil 29350090 439687691 nelivaptan 29350090 691852581 nesbuvir 29350090 778576628 oglemilast 29350090 444731526 pazopanib 29350090 362505848 relacatib 29350090 243984114 resatorvid 29350090 519055620 tasisulam 29350090 186497074 zibotentan 29362900 104121928 eldecalcitol 29362900 31690092 levomefolicacid 29371900 782500758 albiglutide 29371900 348119846 obinepitide 29371900 295350457 ozarelix 29371900 275371943 taspoglutide 29371900 218949485 tesamorelin 29371900 22006640 tridecactide

29372200 132245579 dexamethasonecipecilate

29372200 397864447 fluticasonefuroate 29372900 211254738 lonaprisan

PECONS59/10 NC/kp 12 ANNEXI DGDDTE EN CNcode CASRN Name 29375000 333963421 cobiprostone 29375000 172740146 posaraprost 29379000 834153876 elagolix 29379000 609799226 tasimelteon 29379000 342577382 velneperit

29391900 73232527 methylnaltrexonebromide

29395900 136199025 rolofylline 29399900 850607588 darotropiumbromide 29399900 187852637 delimotecan 29400000 9007721 ferriccarboxymaltose

29400000 442201243 remogliflozinetabonate

29400000 408504267 sergliflozinetabonate 29419000 467214206 alvespimycin 29419000 677017231 berubicin 29419000 229016733 ceftarolinefosamil 29419000 318498769 flopristin 29419000 145435729 gamithromycin 29419000 325965239 linopristin 29419000 857402234 retaspimycin 29419000 305841296 sagopilone 29419000 75747147 tanespimycin 29419000 328898404 tildipirosin 29419000 222400206 tomopenem 29419000 63409121 tylvalosin

PECONS59/10 NC/kp 13 ANNEXI DGDDTE EN CNcode CASRN Name 30019091 9041081 semuloparinsodium 30021091 792921109 abagovomab 30021091 910649320 anrukinzumab 30021091 648904283 bavituximab 402710274 (lightchain) 30021091 canakinumab 402710252 (heavychain)

30021099 945228499 citatuzumabbogatox

30021091 880486599 dacetuzumab 30021091 615258407 denosumab 30021091 762260742 efungumab 30021091 89957379 gantenerumab 30021091 680188334 ibalizumab 30021091 477202009 ipilimumab 30021091 640735097 iratumumab 30021091 845816026 lexatumumab 30021091 903512505 lucatumumab 30021091 899796839 milatuzumab 30021091 677010343 motavizumab

30021091 676258983 naptumomabestafenatox

30021091 828933513 nimotuzumab 30021091 949142501 obinutuzumab 30021091 637334453 ocrelizumab

PECONS59/10 NC/kp 14 ANNEXI DGDDTE EN CNcode CASRN Name 30021091 881191442 otelixizumab 30021091 372075371 sontuzumab 30021091 705287601 stamulumab 30021091 339086805 tadocizumab 592557432 (lightchain) 30021091 tenatumomab 592557410 (heavychain) 30021091 876387052 teplizumab 30021091 918127534 tigatuzumab 30021091 745013596 tremelimumab

30021091 339986902 tucotuzumabcelmoleukin

30021091 728917188 veltuzumab 30021091 896731821 conatumumab 30021091 892553423 etaracizumab 30021091 944548383 foravirumab 30021091 944548372 rafivirumab 30021091 880266579 tanezumab 30021091 815610630 ustekinumab 30021095 862111328 aflibercept 30021095 845264928 atacicept 30021095 909110254 baminercept 30021095 9001278 beroctocogalfa 30021095 879555132 epoetinkappa 30021095 762263149 epoetintheta

PECONS59/10 NC/kp 15 ANNEXI DGDDTE EN CNcode CASRN Name 30021095 501081761 rilonacept 30021095 267639769 romiplostim 30021095 869858139 thrombinalfa

30021095 897936899 vatreptacogalfa(activated)

30021095 472960228 albinterferonalfa2b 30021095 869881549 briobacept 30021095 606138083 catridecacog 30021095 716840323 denenicokin 30021095 931101847 troplasminogenalfa 30021099 934216543 alacizumabpegol 30022000 181477430 disomotide 30022000 181477918 ovemotide 30022000 915019088 tertomotide 30022000 295371005 verpasepcaltespen

30029090 473553865 alferminogenetadenovec

30029090 929881050 alipogenetiparvovec

30029090 600735737 contusugeneladenovec

30029090 851199592 linaclotide

30029090 898830541 sitimageneceradenovec

30029090 721946425 transferrinaldifitox 35079090 9026000 bucelipasealfa 35079090 885051901 pegloticase 35079090 884604915 velaglucerasealfa 39119099 892497017 azoximerbromide

PECONS59/10 NC/kp 16 ANNEXI DGDDTE EN ANNEX II

List of prefixes and suffixes which, in combination with the INNs of Annex 3 to Annex I to Regulation (EEC) No 2658/87, describe the salts, esters or hydrates of INNs; these salts, esters and hydrates are free of duty, on condition that they are classifiable in the same six-digit HS subheading as the corresponding INN

Thereferencesto"InternationalNonproprietaryNames(INN)forpharmaceuticalsubstances, namesforradicalsandgroups,comprehensivelist2004"arereplacedby"International NonproprietaryNames(INN)forpharmaceuticalsubstances,namesforradicals,groupsandothers, comprehensivelist2007".

ThefollowingprefixesorsuffixesareaddedtothelistincludedinAnnex4toAnnexIto Regulation(EEC)No2658/87:

Preferredprefixor Synonym Systematicnamewhen suffix different alanetil(INNRG) [(S)1ethoxy1oxopropan 2yl]amino(INNCN) alaninate(INNRG) Lalaninate(INNCN) alapivoxil(INNRG) Lalanyl,[(2,2 dimethylpropanoyl)oxy]metyl (INNCN)

PECONS59/10 NC/kp 1 ANNEXII DGDDTE EN Preferredprefixor Synonym Systematicnamewhen suffix different aldifitox(INNRG) (4iminobutane1,4 diyl)sulfanediyl[(3RS)2,5 dioxopyrrolidine1,3diyl] 1,3phenylenecarbonyland forminganNbenzoyl derivativeofaprimaryamine groupofdiphtheria[550L phenylalanine]toxinfrom Corynebacterium diphtheriae (26560)peptide (INNCN) besudotox(INNRG) LlysylLalanylL serylglycylglycine(linker) fusionproteinwithdes(365 380) [Asn 364 ,Val 407 ,Ser 515 ,Gln 590 ,G ln 606 ,Arg 613 ]exotoxinA (Pseudomonas aeruginosa ) (251613)peptide(toxinwith regionIAandfirst16 residuesofregionIBdeleted) (INNCN) ceribate(INNRG) rac2,3dihydroxypropyl carbonate(ester)(INNCN)

PECONS59/10 NC/kp 2 ANNEXII DGDDTE EN Preferredprefixor Synonym Systematicnamewhen suffix different cipecilate(INNRG) cyclohexanecarboxylate (ester), cyclopropanecarboxylate (ester)(INNCN) dalanated(INNRG) desB30alanine(INNCN) enacarbil(INNRG) {rac1[(2 methylpropanoyl)oxy]ethoxy }carbonyl(INNCN) estafenatox(INNRG) glycylglycylLproline (linker)fusionproteinwith enterotoxintypeA (Staphylococcus aureus )(1 33)peptidylL seryl[Ser 36 ,Ser 37 ,Glu 38 ,Lys 39 , Ala 41 ,Thr 46 ,Thr 71 ,Ala 72 ,Ser 75 , Glu 76 ,Glu 78 ,Ser 80 ,Ser 81 ,Thr 214 , Ser 217 ,Thr 219 ,Ser 220 ,Ser 222 ,Ser 2 24 ]enterotoxintypeE (Staphylococcus aureus )(32 230)peptide(synthetic superantigenSEA/E120) (INNCN) etexilate(INNRG) ethyl,(hexyloxy)carbonyl

PECONS59/10 NC/kp 3 ANNEXII DGDDTE EN Preferredprefixor Synonym Systematicnamewhen suffix different fosamil(INNRG) phosphono(INNCN) glucuronide(INNRG) βDglucopyranosiduronic acid[oside](INNCN) medocaril(INNRG) [(5methyl2oxo1,3dioxol 4yl)methoxy]carbonyl (INNCN) paptox(INNRG) proteinPAP( Phytolacca americana antiviral) (INNCN) placarbil(INNRG) (R)2methyl1[(2 methylpropanoyl)oxy]propox y}carbonyl)(INNCN)

Thesystematicnameofthefollowingprefixorsuffixisamendedasfollows:

Preferredprefixor Synonym Systematicnamewhen suffix different aritox(INNRG) ricinAchain(INNCN)

PECONS59/10 NC/kp 4 ANNEXII DGDDTE EN ANNEX III

List of pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to be added to the list of products receiving duty-free treatment included in Annex 6 to Annex I to Regulation (EEC) No 2658/87

CNcode CASRN Name [4aminoN(pyrimidin2(1H)ylidene 28432900 22199082 κN1)benzenesulfonamidatoκO]silver (2R,3R)2,3dimethylbutane1,4diylbis(4 29053995 281214275 methylbenzenesulfonate) 29055998 441002171 4chlorobutyl2nitrobenzenesulfonate 29093090 92878950 2(3chloropropoxy)1methoxy4nitrobenzene

290930 503070573 2({2[(6bromohexyl)oxy]ethoxy}methyl)1,3dichlorobenzene

290930 461432235 4(5bromo2chlorobenzyl)phenylethylether

29094980 185954750 (3R)3methoxydecan1ol 29094980 85309917 2[(2,6dichlorobenzyl)oxy]ethanol

29094980 160969039 2[2(2,2,2trifluoroethoxy)phenoxy]ethylmethanesulfonate

29095000 167145133 2[2(3methoxyphenyl)ethyl]phenol 29102000 15448472 (2R)2methyloxirane 29109000 62600719 (2R)2(3chlorophenyl)oxirane 29109000 702687421 (2R)2[(5bromo2,3difluorophenoxy)methyl]oxirane

PECONS59/10 NC/kp 1 ANNEXIII DGDDTE EN CNcode CASRN Name

29109000 683276644 [(2R)2methyloxiran2yl]methyl4nitrobenzenesulfonate

29130000 90035340 4'(trifluoromethyl)biphenyl4carbaldehyde 29144090 17752168 (3β)3hydroxycholest5en24one

29145000 974232 (3β,16α)3hydroxy16,17epoxypregn5en20one

29147000 13054814 4chloroheptane3,5dione

29147000 10226309 6chlorohexan2one 29156090 53064792 iodomethylpivalate 29159000 22328901 (3R)3methylhexanoicacid 29159000 1069665 sodium2propylpentanoate 29162000 211515467 1(2ethylbutyl)cyclohexanecarbonylchloride 29162000 381209092 1(2ethylbutyl)cyclohexanecarboxylicacid 29162000 7077056 trans4(propan2yl)cyclohexanecarboxylicacid 29163900 21900390 5fluoro2methylbenzoylchloride 29163900 17625035 sodiumhydrogen3sulfonatobenzoate

29171990 76722 diethylethyl(pentan2yl)propanedioate

29182900 376592584 5'chloro2'hydroxy3'nitrobiphenyl3carboxylicacid

29189990 709031287 (3hydroxytricyclo[3.3.1.1(3,7)]dec1yl)(oxo)aceticacid

29189990 35480525 2,5bis(2,2,2trifluoroethoxy)benzoicacid 29189990 4651676 (3α,5β)3hydroxy7oxocholan24oicacid ethyl2[4(2,2dichlorocyclopropyl)phenoxy]2 29189990 52179289 methylpropanoate

PECONS59/10 NC/kp 2 ANNEXIII DGDDTE EN CNcode CASRN Name methyl3(5{[4(cyclopentyloxy)2hydroxyphenyl]carbonyl}2 29189990 530141607 hydroxyphenyl)propanoate 29209010 91526180 4(hydroxymethyl)5methyl1,3dioxol2one

29214900 334477600 (1R)1[3,5bis(trifluoromethyl)phenyl]Nmethylethanamine

(1R,2S)2(3,4difluorophenyl)cyclopropanaminium(2R) 29214900 376608718 hydroxy(phenyl)ethanoate

29214900 1034457072 2(2,3dihydro1Hinden2yl)propan2aminehydrochloride

29214900 945717055 2(4chloro3ethylphenyl)ethanaminehydrochloride 29214900 89974 2chlorobenzylamine

29214900 945717431 N(4tertbutylbenzyl)2(4chloro3ethylphenyl)ethanamine

29215190 150812218 N4[(4fluorophenyl)methyl]2nitro1,4benzenediamine

(2R)1(5bromo2,3difluorophenoxy)3{[1(2,3dihydro1H 29221985 1035455903 inden2yl)2methylpropan2 yl]amino}propan2olhydrochloride [2(chloromethyl)4(dibenzylamino)phenyl]methanol 29221985 0000 hydrochloride

29221985 133517 antimonicacid1deoxy1(methylamino)Dglucitol(1:1)

PECONS59/10 NC/kp 3 ANNEXIII DGDDTE EN CNcode CASRN Name ethyl(2E)3(3{[(2R)3{[1(2,3dihydro1Hinden2yl)2 29221985 1035455878 methylpropan2yl]amino}2hydroxypropyl]oxy}4,5 difluorophenyl)prop2enoatehydrochloride ethyl3(3{[(2R)3{[1(2,3dihydro1Hinden2yl)2 29221985 702686973 methylpropan2yl]amino}2hydroxypropyl]oxy}4,5 difluorophenyl)propanoatehydrochloride 29222900 20059738 2[4(aminomethyl)phenoxy]N,Ndimethylethanamine 29224985 848133357 (2E)4(dimethylamino)but2enoicacidhydrochloride 29224985 610300077 (3S,5R)3amino5methyloctanoicacid 29224985 610300000 (3S,5R)3amino5methyloctanoicacidhydrochloride 29224985 143785868 4(1aminocyclopropyl)2,3,5trifluorobenzoicacid 29224985 848949859 4fluoroLleucineethylhydrogensulfate(1:1) 29224985 39068934 methyl2(dimethylamino)2phenylbutanoate 29224985 168619258 methyl3'aminobiphenyl3carboxylate 29224985 82834126 N[(2S)1ethoxy1oxopentan2yl]Lalanine 29224985 94133843 sodium2amino2phenylbutanoate triphenylaceticacid4{(1R)2[(6{2[(2,6 29225000 503070584 dichlorobenzyl)oxy]ethoxy}hexyl)amino]1hydroxyethyl}2 (hydroxymethyl)phenol(1:1) 29241900 62009476 2aminomalonamide 29241900 7355580 N(2chloroethyl)acetamide

PECONS59/10 NC/kp 4 ANNEXIII DGDDTE EN CNcode CASRN Name {2[(tertbutoxycarbonyl)amino]3 29242998 361442004 hydroxytricyclo[3.3.1.1(3,7)]dec1yl}aceticacid 29242998 266993720 2,3diaminobenzamidedihydrochloride 2chloro4{[(5fluoro2methylphenyl)carbonyl]amino}benzoic 29242998 168080497 acid

29242998 317374086 2methyl4{[(2methylphenyl)carbonyl]amino}benzoicacid

29242998 143785846 4(1carbamoylcyclopropyl)2,3,5trifluorobenzoicacid

29242998 143785879 4[1(acetylamino)cyclopropyl]2,3,5trifluorobenzoicacid

29242998 108166229 4{[(2methylphenyl)carbonyl]amino}benzoicacid

29242998 150812230 ethyl{4[(4fluorobenzyl)amino]2nitrophenyl}carbamate

ethyl3[(5chloro2nitrophenyl)(phenyl)amino]3 29242998 22316456 oxopropanoate methyl(1S,2S,3S,4R)3[(1S)1amino2ethylbutyl]4[(tert 29242998 316173292 butoxycarbonyl)amino]2hydroxycyclopentanecarboxylate 29242998 1142207 NbenzyloxycarbonylLalanine 29242998 84996930 Ncyclohexyl5hydroxypentanamide propyl{4[2(diethylamino)2oxoethoxy]3 29242998 579494669 ethoxyphenyl}acetate

PECONS59/10 NC/kp 5 ANNEXIII DGDDTE EN CNcode CASRN Name ethyl3amino4[2(1,3dioxo1,3dihydro2Hisoindol2 29251995 265136650 yl)ethoxy]but2enoate 29269095 855425386 1(2ethylbutyl)cyclohexanecarbonitrile

29269095 846023243 2cyanoN(2,4dichloro5methoxyphenyl)acetamide

29269095 591769050 3cyclopentylprop2enenitrile 29269095 20099892 4(bromoacetyl)benzonitrile 29269095 474554455 4,5diethoxy3fluorobenzene1,2dicarbonitrile 29269095 79370788 5hydroxybenzene1,3dicarbonitrile methyl2{[(2'cyanobiphenyl4yl)methyl]amino}3 29269095 139481280 nitrobenzoate 1({[(2,5dioxopyrrolidin1yl)oxy]carbonyl}oxy)ethyl2 29280090 860035105 methylpropanoate 29280090 910656450 2hydroxy2(trifluoromethyl)butanehydrazide

29280090 95759107 4chloro2[(2methoxy2oxoethoxy)imino]3oxobutanoicacid

29280090 473927638 ethyl(2Z)chloro[2(4methoxyphenyl)hydrazinylidene]ethanoate

29280090 158671295 N,2dihydroxy4methylbenzamide tertbutyl(2Z)2[(2methoxy2oxoethoxy)imino]3 29280090 84080682 oxobutanoate

29280090 268544509 tertbutyl2[(2methoxy2oxoethoxy)imino]3oxobutanoate

29309099 13459626 {2[(4chlorophenyl)sulfanyl]phenyl}aceticacid

PECONS59/10 NC/kp 6 ANNEXIII DGDDTE EN CNcode CASRN Name

29309099 211513212 1(2ethylbutyl)N(2sulfanylphenyl)cyclohexanecarboxamide

29309099 860035070 1{[(methylsulfanyl)carbonyl]oxy}ethyl2methylpropanoate

29309099 893407186 2,2,2trifluoro1[4'(methylsulfonyl)biphenyl4yl]ethanone

29309099 60759004 3,4diethoxybenzenecarbothioamide 29309099 21048055 Nmethylbenzenecarbothiohydrazide 29310099 13682945 (2bromoethenyl)(trimethyl)silane (2R,4R)4[[(1,1dimethylethyl)dimethylsilyl]oxy]Nmethoxy 29310099 914922897 N,2dimethyl7oxoheptanamide (2R,4R)4{[tertbutyl(dimethyl)silyl]oxy}NmethoxyN,2 29310099 914922886 dimethyloct7enamide (4R)2bromo7{[tertbutyl(diphenyl)silyl]oxy}hept1en4yl4 29310099 871355805 methylbenzenesulfonate 29310099 89694484 (5chloro2methoxyphenyl)boronicacid [(1R,5S)5[dimethyl(phenyl)silyl]2{[(2methoxypropan2 29310099 701278082 yl)oxy]methyl}cyclopent2en1yl]methanol {(4S,5R)5[(benzyloxy)methyl]4 29310099 701278093 [dimethyl(phenyl)silyl]cyclopent1en1yl}methanol 1(2fluoro5methylphenyl)3[4(4,4,5,5tetramethyl1,3,2 29310099 796967185 dioxaborolan2yl)phenyl]urea

PECONS59/10 NC/kp 7 ANNEXIII DGDDTE EN CNcode CASRN Name 29310099 172732524 2(1,3,2dioxaborinan2yl)benzonitrile 29310099 185411125 methyl3(trimethylsilyl)pent4enoate (1S)1,5:7,10dianhydro12,13bisO[tertbutyl(dimethyl)silyl] 2,3,4,6,8,11hexadeoxy1{2[(2S,5S)5(3hydroxypropyl)3 29321900 253128108 methylidenetetrahydrofuran2yl]ethyl}3methyl9Omethyl4 methylidene8[(phenylsulfonyl)methyl]DarabinoDaltro tridecitol (1S,3S,6S,9S,12S,14R,16R,18S,20R,21R,22S,26R,29S,31R,32S, 33R,35R,36S)20[(2S)3amino2hydroxypropyl]21methoxy 29321900 441045176 14methyl8,15bis(methylene)2,19,30,34,37,39,40,41 octaoxanonacyclo[24.9.2.13,32.13,33.16,9.112,16.018,22.029,36. 031,35]hentetracontan24onemethanesulfonate 29322985 916069802 (4S)4(fluoromethyl)dihydrofuran2(3H)one 29322985 63106934 1phenyl3oxabicyclo[3.1.0]hexan2one 29322985 7734807 2oxo2Hchromene6carboxylicacid

29322985 0000 4(4fluorophenyl)7(isothiocyanatomethyl)2Hchromen2one

29322985 947408915 6[(2,4dihydroxyphenyl)carbonyl]2Hchromen2one 29322985 947408904 6[(2,4dimethoxyphenyl)carbonyl]2Hchromen2one

PECONS59/10 NC/kp 8 ANNEXIII DGDDTE EN CNcode CASRN Name (1R)2(benzylamino)1(2,2dimethyl4H1,3benzodioxin6 29329900 452342084 yl)ethanol (1R,2S,3R,4R,5R)4azido2{[(4aR,6S,7R,8S,8aR)7,8 29329900 99541238 bis(benzyloxy)2phenylhexahydropyrano[3,2d][1,3]dioxin6 yl]oxy}6,8dioxabicyclo[3.2.1]oct3ylacetate (1S)2,3,4,6tetraOacetyl1,5anhydro1[4chloro3(4 29329900 461432257 ethoxybenzyl)phenyl]Dglucitol (2E)1,2,6,7tetrahydro8Hindeno[5,4b]furan8 29329900 196597792 ylideneethanenitrile

29329900 3308949 2(3chloropropyl)2(4fluorophenyl)1,3dioxolane

[(3aS,4R,6S,6aR)6hydroxy2,2dimethyltetrahydro3aH 29329900 274693537 cyclopenta[d][1,3]dioxol4yl]carbamate [6(2Z,3R)]3Odecyl2deoxy6O[2deoxy3O(3 metoxydecyl)6methyl2[(1oxo11octadecenyl)amino]4O 29329900 185954987 phosphonoβDglucopyranosyl]2[(1,3dioxotetradecyl)amino] αDglucopyranose1(dihydrogenphosphate)tetrasodiumsalt 1,6diOacetyl2azido3,4diObenzyl2deoxyD 29329900 136172582 glucopyranose 2[(8S)1,6,7,8tetrahydro2Hindeno[5,4b]furan8 29329900 196597805 yl]ethanaminehydrochloride

PECONS59/10 NC/kp 9 ANNEXIII DGDDTE EN CNcode CASRN Name 2amino2oxoethyl{3[trans5(6methoxynaphthalen1yl)1,3 29329900 666860599 dioxan2yl]propyl}carbamate 29329900 117661720 5(chloromethyl)6methyl1,3benzodioxole

29329900 959624249 6(hydroxymethyl)4phenyl3,4dihydro2Hchromen2ol

but2yne1,4diolmethyl1C[4chloro3(4 29329900 960404595 ethoxybenzyl)phenyl]αDglucopyranoside(1:1) disodium5,5'[(2hydroxypropane1,3diyl)bis(oxy)]bis(4oxo 29329900 15826376 4Hchromene2carboxylate) ethyl(3aR,7R,7aR)2,2dimethyl7[(methylsulfonyl)oxy] 29329900 204254842 3a,6,7,7atetrahydro1,3benzodioxole5carboxylate methyl(2S,3S,4S,5S,6S)6{[(1S,2S,3S,4R,5R)3(acetyloxy)4 29329900 99541261 azido6,8dioxabicyclo[3.2.1]oct2yl]methyl}4,5 bis(benzyloxy)3hydroxytetrahydro2Hpyran2carboxylate methyl6Oacetyl4O(2Oacetyl3Obenzyl6methylαL 29329900 114869975 idopyranuronosyl)3Obenzyl2{[(benzyloxy)carbonyl]amino} 2deoxyαDglucopyranoside (4S)3(4chlorophenyl)Nmethyl4phenyl4,5dihydro1H 29331990 1035677601 pyrazole1carboximidamide2,3dihydroxybutanedioate

PECONS59/10 NC/kp 10 ANNEXIII DGDDTE EN CNcode CASRN Name

29331990 18048641 2(3,4dimethylphenyl)5methyl2,4dihydro3Hpyrazol3one

3(4chlorophenyl)Nmethyl4phenyl4,5dihydro1Hpyrazole 29331990 1035675241 1carboximidamide 5methyl1(propan2yl)4[4(propan2yloxy)benzyl]1,2 29331990 1028026836 dihydro3Hpyrazol3one 5{[3,5diethyl1(2hydroxyethyl)1Hpyrazol4 29331990 473921129 yl]oxy}benzene1,3dicarbonitrile 29332990 65902592 2bromo4nitro1Himidazole 29332990 57531370 2chloro4nitro1Himidazole 3(1,1dimethylethyl)N[(9Hfluoren9ylmethoxy)carbonyl]1 29332990 1000164351 (triphenylmethyl)Lhistidyl2methylalanylLαglutamylglycine LαaspartylLαglutamylLasparaginylLprolylLvalylL valylLhistidylLphenylalanylLphenylalanylLlysylL 29332990 152074970 asparaginylLisoleucylLvalylLthreonylLprolylLarginylL threonine LαaspartylLαglutamylLasparaginylLprolylLvalylL valylLhistidylLphenylalanylLphenylalanylLlysylL 29332990 781666306 asparaginylLisoleucylLvalylLthreonylLprolylLarginylL threoninetetraacetate methyl3'(2methyl4,5dihydro1Himidazol1yl)biphenyl3 29332990 451470330 carboxylate

PECONS59/10 NC/kp 11 ANNEXIII DGDDTE EN CNcode CASRN Name (+)5[6(1methyl1Hpyrazol4yl)pyridin3yl]1 29333999 925978490 azabicyclo[3.2.1]octane (1S,5S)3(5,6dichloropyridin3yl)3,6 29333999 876170444 diazabicyclo[3.2.0]heptanebenzenesulfonate

29333999 741705704 (2R)phenyl[(2R)piperidin2yl]ethanoicacidhydrochloride

(2S)hydroxy(phenyl)ethanoicacid(2R)2(4fluoro2 29333999 414910137 methylphenyl)piperidin4one(1:1) (3aR,6aR)1(pyridin3yl)octahydropyrrolo[3,4b]pyrrole4 29333999 0000 methylbenzenesulfonate (3aR,6aR)1(pyridin3yl)octahydropyrrolo[3,4b]pyrrole 29333999 370882578 dihydrochloride 29333999 334618234 (3R)piperidin3aminedihydrochloride (3R,4R)1benzylN,4dimethylpiperidin3amine 29333999 1062580522 dihydrochloride

29333999 27262471 (S)1butylN(2,6dimethylphenyl)piperidine2carboxamide

29333999 105812815 [(3S,4R)4(4fluorophenyl)1methylpiperidin3yl]methanol

[(3S,4S)4amino1(5,6dichloropyridin3yl)pyrrolidin3 29333999 876068518 yl]methanol 1({4[({[2oxo3(propan2yl)2,3dihydro1Hbenzimidazol1 29333999 871022149 yl]carbonyl}amino)methyl]piperidin1 yl}methyl)cyclobutanecarboxylicacid

PECONS59/10 NC/kp 12 ANNEXIII DGDDTE EN CNcode CASRN Name 29333999 5421921 1(pyridin4yl)pyridiniumchloridehydrochloride 1,1'binaphthalene2,2'diol 5methoxy2{(S)[(4methoxy3,5dimethylpyridin2 29333999 272776122 yl)methyl]sulfinyl}1Hbenzimidazole (1:1) 1[(4{[(tertbutoxycarbonyl)amino]methyl}piperidin1 29333999 871022194 yl)methyl]cyclobutanecarboxylicacid 2,8dimethyl5[2(6methylpyridin3yl)ethyl]2,3,4,5 29333999 3613738 tetrahydro1Hpyrido[4,3b]indole 29333999 179687797 2[(2chloro4nitrophenoxy)methyl]pyridine 29333999 122321044 2[methyl(pyridin2yl)amino]ethanol 2methyl3[(2S)pyrrolidin2ylmethoxy]pyridine2,3 29333999 945405378 dihydroxybutanedioate

29333999 936637400 3,3'piperidine1,4diyldipropan1ol4methylbenzenesulfonate

3ethyl5methyl4(2chlorophenyl)2{[2(1,3dioxo1,3 29333999 88150623 dihydro2Hisoindol2yl)ethoxy]methyl}6methyl1,4 dihydropyridine3,5dicarboxylate 29333999 84100549 4(ethylamino)piperidine4carboxamide 4,4'[piperidine1,4diylbis(propane3,1diyloxy)]bis(N' 29333999 873546306 hydroxybenzenecarboximidamide) 4,4'[piperidine1,4diylbis(propane3,1diyloxy)]bis[N' 29333999 873546748 (acetyloxy)benzenecarboximidamide]

PECONS59/10 NC/kp 13 ANNEXIII DGDDTE EN CNcode CASRN Name 4,4'[piperidine1,4diylbis(propane3,1 29333999 873546384 diyloxy)]dibenzenecarboximidamidetrihydrochloride pentahydrate

29333999 873546806 4,4'[piperidine1,4diylbis(propane3,1diyloxy)]dibenzonitrile

29333999 78750615 4[(3nitropyridin2yl)amino]phenol 4{4[4(trifluoromethoxy)phenoxy]piperidin1yl}phenol4 29333999 866109935 methylbenzenesulfonate 29333999 927889518 4bromo2,6diethylpyridine4methylbenzenesulfonate 4hydroxybenzoicacid(2S,4E)Nmethyl5[5(propan2 29333999 691882470 yloxy)pyridin3yl]pent4en2amine(1:1) 29333999 876068461 5,6dichloroN(2,2dimethoxyethyl)pyridin3amine 29333999 1072986 5chloropyridin2amine 29333999 298692349 6(chloroacetyl)pyridine2carboxylicacid 7chloro3(6methoxypyridin3yl)N,N,5trimethyl4oxo4,5 29333999 550349581 dihydro3Hpyridazino[4,5b]indole1carboxamide benzyl2(4fluoro2methylphenyl)4oxo3,4dihydropyridine 29333999 414909981 1(2H)carboxylate

29333999 56880116 ethyl[(3endo)8methyl8azabicyclo[3.2.1]oct3yl)acetate

PECONS59/10 NC/kp 14 ANNEXIII DGDDTE EN CNcode CASRN Name N(2{[(2S)3{[1(4chlorobenzyl)piperidin4yl]amino}2 29333999 548797973 hydroxy2methylpropyl]oxy}4hydroxyphenyl)acetamide N[(S)1azabicyclo[2.2.2]oct2yl(phenyl)methyl]2,6dichloro 29333999 0000 3(trifluoromethyl)benzamidehydrochloride sodiumhydrogen[1hydroxy1phosphono2(pyridin3 29333999 329003658 yl)ethyl]phosphonatehemipentahydrate

4{3chloro4[(cyclopropylcarbamoyl)amino]phenoxy}7 29334910 417716928 methoxyquinoline6carboxamidemethanesulfonate

2ethylbutyl(3S,4aS,6S,8aR)6[3chloro2(1Htetrazol5 29334990 503291530 yl)phenoxy]decahydro3isoquinolinecarboxylate4 methylbenzenesulfonate benzyl(3S)6,7dimethoxy1,2,3,4tetrahydroisoquinoline3 29334990 103733320 carboxylatehydrochloride (3S,4aS,6S,8aR)6hydroxy2 29334990 503293989 (methoxycarbonyl)decahydroisoquinoline3carboxylicacid (3S,4aS,6S,8aR)6[3chloro2(2Htetrazol5 29334990 503290662 yl)phenoxy]decahydro3isoquinolinecarboxylicacid hydrochloride (3S,4aS,8aR)2(methoxycarbonyl)6oxodecahydroisoquinoline 29334990 134388957 3carboxylicacid (1R)1phenylethanamine(1:1)

PECONS59/10 NC/kp 15 ANNEXIII DGDDTE EN CNcode CASRN Name 4(4{[(2S,4R)4[acetyl(4chlorophenyl)amino]2methyl3,4 29334990 868210144 dihydroquinolin1(2H)yl]carbonyl}phenoxy)2,2 dimethylbutanoicacid methyl2[(3R)3{3[(E)2(7chloroquinolin2 yl)ethenyl]phenyl}3({[1 29334990 00000 (hydroxymethyl)cyclopropyl]methyl}sulfanyl)propyl]benzoate hydrochloride 29334990 848133766 N(4chloro3cyano7ethoxyquinolin6yl)acetamide (3,3difluoropyrrolidin1yl){(2S,4S)4[4(pyrimidin2 29335995 869490233 yl)piperazin1yl]pyrrolidin2yl}methanone (3R)3cyclopentyl3[4(7{[2(trimethylsilyl)ethoxy]methyl} 29335995 941685401 7Hpyrrolo[2,3d]pyrimidin4yl)1Hpyrazol1yl]propanenitrile (3R)3cyclopentyl3[4(7Hpyrrolo[2,3d]pyrimidin4yl)1H 29335995 941678495 pyrazol1yl]propanenitrile (3S)3cyclopentyl3[4(7{[2(trimethylsilyl)ethoxy]methyl} 29335995 941685412 7Hpyrrolo[2,3d]pyrimidin4yl)1Hpyrazol1yl]propanenitrile [(8R)8(3,5difluorophenyl)10oxo6,9diazaspiro[4.5]dec9 29335995 957187347 yl]aceticacid {2[(4fluorobenzyl)sulfanyl]4oxo4,5,6,7tetrahydro1H 29335995 356058429 cyclopenta[d]pyrimidin1yl}aceticacid

PECONS59/10 NC/kp 16 ANNEXIII DGDDTE EN CNcode CASRN Name 2,3dihydroxy2,3bis(phenylcarbonyl)butanedioicacidethyl 29335995 0000 [(8R)8(3,5difluorophenyl)10oxo6,9diazaspiro[4.5]dec9 yl]acetate(1:1) 29335995 90213664 2,4dichloro7Hpyrrolo[2,3d]pyrimidine 29335995 3934201 2,4dichloropyrimidine 2[(4fluorobenzyl)sulfanyl]1,5,6,7tetrahydro4H 29335995 451487186 cyclopenta[d]pyrimidin4one 2[(6chloro3methyl2,4dioxo3,4dihydropyrimidin1(2H) 29335995 865758969 yl)methyl]benzonitrile 2[3(6{[2(2,4dichlorophenyl)ethyl]amino}2 29335995 934815711 methoxypyrimidin4yl)phenyl]2methylpropanoicacid phosphate 2{ethyl[3({4[(5{2[(3fluorophenyl)amino]2oxoethyl}1H 29335995 722543319 pyrazol3yl)amino]quinazolin7yl}oxy)propyl]amino}ethyl dihydrogenphosphate 2amino9{(1S,3R,4S)3[(benzyloxy)methyl]4 29335995 1032066968 [dimethyl(phenyl)silyl]2methylidenecyclopentyl}1,9dihydro 6Hpurin6onemethanesulfonate(2:1) 3{(3R,4R)4methyl3[methyl(7Hpyrrolo[2,3d]pyrimidin4 29335995 540737299 yl)amino]piperidin1yl}3oxopropanenitrile2hydroxypropane 1,2,3tricarboxylate

PECONS59/10 NC/kp 17 ANNEXIII DGDDTE EN CNcode CASRN Name 3{[6(ethylsulfonyl)pyridin3yl]oxy}5{[(2S)1 29335995 1137917124 hydroxypropan2yl]oxy}benzoicacid1,4 diazabicyclo[2.2.2]octane(2:1) 3cyclopentyl3[4(7{[2(trimethylsilyl)ethoxy]methyl}7H 29335995 941685398 pyrrolo[2,3d]pyrimidin4yl)1Hpyrazol1yl]propanenitrile 4(1Hpyrazol4yl)7{[2(trimethylsilyl)ethoxy]methyl}7H 29335995 941685274 pyrrolo[2,3d]pyrimidine 29335995 1780263 4,6dichloro2methylpyrimidine 29335995 145783148 4,6dichloro5nitro2(propylsulfanyl)pyrimidine 29335995 3680691 4chloro7Hpyrrolo[2,3d]pyrimidine 29335995 61379644 4cyclopentylpiperazin1amine 29335995 55112420 4methylpiperazine1carbonylchloridehydrochloride 5(benzylamino)2(3methoxyphenyl)7(4methylpiperazin1 29335995 0000 yl)[1,2,4]triazolo[1,5a]quinoline4carbonitrile(2E)but2 enedioate(2:1)hydrate

29335995 55293964 5,7dimethyl[1,2,4]triazolo[1,5a]pyrimidine2carbaldehyde

29335995 179688018 7(benzyloxy)6methoxyquinazolin4(3H)one

29335995 444731742 N(2chloropyrimidin4yl)2,3dimethyl2Hindazol6amine

PECONS59/10 NC/kp 18 ANNEXIII DGDDTE EN CNcode CASRN Name N(5fluoro3methyl1Hindol1yl)4methyl2(pyridin2 29335995 0000 yl)pyrimidine5carboxamide ()3{3bromo4[(2,4difluorobenzyl)oxy]6methyl2 29337900 586414484 oxopyridin1(2H)yl}N,4dimethylbenzamide (1S)1amino3methyl1,3,4,5tetrahydro2H3benzazepin2 29337900 425663714 onehydrochloride (4S)1[(2S,3S,11bS)2amino9,10dimethoxy1,3,4,6,7,11b 29337900 813452141 hexahydro2Hpyrido[2,1a]isoquinolin3yl]4 (fluoromethyl)pyrrolidin2onedihydrochloride 29337900 5162903 3(2oxo1,2dihydroquinolin4yl)alanine

29337900 536760299 3chloro1(4nitrophenyl)5,6dihydropyridin2(1H)one

29337900 4876102 4(bromomethyl)quinolin2(1H)one 29337900 5057125 4,6,7,8tetrahydroquinoline2,5(1H,3H)dione 29337900 54197669 6hydroxy3,4dihydroquinolin2(1H)one 29337900 22246180 7hydroxy3,4dihydroquinolin2(1H)one ethyl1(4methoxyphenyl)6(4nitrophenyl)7oxo4,5,6,7 29337900 536759918 tetrahydro1Hpyrazolo[3,4c]pyridine3carboxylate ethyl1(4methoxyphenyl)7oxo6[4(2oxopiperidin1 29337900 503614913 yl)phenyl]4,5,6,7tetrahydro1Hpyrazolo[3,4c]pyridine3 carboxylate methyl3(4hydroxy6methyl2oxopyridin1(2H)yl)4 29337900 586379615 methylbenzoate

PECONS59/10 NC/kp 19 ANNEXIII DGDDTE EN CNcode CASRN Name (1S,3S,5S)2azabicyclo[3.1.0]hexane3carboxamide 29339980 709031458 methanesulfonate (2R)1({4[(4fluoro2methyl1Hindol5yl)oxy]5 29339980 649735466 methylpyrrolo[2,1f][1,2,4]triazin6yl}oxy)propan2ol 29339980 51077146 (2S)1(tertbutoxycarbonyl)azetidine2carboxylicacid (2S)N{4[(Z)amino(methoxyimino)methyl]benzyl}1{(2R)2 [3chloro5(difluoromethoxy)phenyl]2 29339980 631916977 hydroxyethanoyl}azetidine2carboxamidebenzenesulphonic acid(1:1) 29339980 80875985 (2S,3aS,7aS)octahydro1Hindole2carboxylicacid (2S,3S)2,3bis[(phenylcarbonyl)oxy]butanedioicacidethyl 29339980 948846400 (3aR,6aR)hexahydropyrrolo[3,4b]pyrrole5(1H)carboxylate (1:1) (5S,8S,11S,14S,17S,20S,23S,26S,29S,32S,35S,38S)5(3amino 3oxopropyl)20benzyl23[(2S)butan2yl]14,38bis{4[(tert butoxycarbonyl)amino]butyl}29{[1(tertbutoxycarbonyl)1H indol3yl]methyl}17(3tertbutoxy3oxopropyl)1(1H 29339980 1000164362 fluoren9yl)8,11,26,41,41pentamethyl32(2methylpropyl) 3,6,9,12,15,18,21,24,27,30,33,36,39tridecaoxo35(propan2yl) 2oxa4,7,10,13,16,19,22,25,28,31,34,37,40 tridecaazadotetracontan42oicacid

PECONS59/10 NC/kp 20 ANNEXIII DGDDTE EN CNcode CASRN Name 29339980 22162512 1(2nitrobenzyl)1Hpyrrole2carbaldehyde 29339980 35681404 1(propan2yl)1,3dihydro2Hbenzimidazol2one 29339980 166170156 1(tertbutoxycarbonyl)2methylDproline 1[4(3amino1Hindazol4yl)phenyl]3(2fluoro5 29339980 796967163 methylphenyl)urea 1[4(3amino1Hindazol4yl)phenyl]3(2fluoro5 29339980 0000 methylphenyl)ureahydrochloride 29339980 444731720 2,3dimethyl2Hindazol6amine 29339980 19686056 2,8dimethyl2,3,4,5tetrahydro1Hpyrido[4,3b]indole 2[(2R)2methylpyrrolidin2yl]1Hbenzimidazole4 29339980 912444009 carboxamide 2[(2S)2methylpyrrolidin2yl]1Hbenzimidazole4 29339980 912445364 carboxamidedihydrochloride 29339980 163457236 3,3difluoropyrrolidinehydrochloride 3{5[(2R)2aminopropyl]7cyano2,3dihydro1Hindol1 29339980 239463855 yl}propylbenzoate(2R,3R)2,3dihydroxybutanedioate 29339980 55321998 3oxo3,4dihydropyrazine2carboxamide 4[(4fluoro2methyl1Hindol5yl)oxy]5methylpyrrolo[2,1 29339980 952490016 f][1,2,4]triazin6yl2,2dimethylpropanoate 4amino8(2,5dimethoxyphenyl)Npropylcinnoline3 29339980 942436933 carboxamide

PECONS59/10 NC/kp 21 ANNEXIII DGDDTE EN CNcode CASRN Name 4amino8(2fluoro6methoxyphenyl)Npropylcinnoline3 29339980 942437378 carboxamide 29339980 288385886 4fluoro2methyl1Hindol5ol 29339980 503293478 5(2chloro6fluorophenyl)2Htetrazole 29339980 73963425 5(4chlorobutyl)1cyclohexyl1Htetrazole 5[(4bromo2chlorophenyl)amino]4fluoroN(2 29339980 606143526 hydroxyethoxy)1methyl1Hbenzimidazole6carboxamide 5fluoro1(3fluorobenzyl)N(1Hindol5yl)1Hindole2 29339980 0000 carboxamide 5methyl4oxo1,4dihydropyrrolo[2,1f][1,2,4]triazin6yl2,2 29339980 872206478 dimethylpropanoate 29339980 259793889 6bromo3oxo3,4dihydropyrazine2carboxamide 6fluoro3oxo3,4dihydropyrazine2carbonitrileN 29339980 1137606746 cyclohexylcyclohexanamine(1:1) 29339980 261953360 6iodo1Hindazole 8,9difluoro5methyl1oxo6,7dihydro1H,5Hpyrido[3,2,1 29339980 80076477 ij]quinoline2carboxylicacid 29339980 52602398 9Hcarbazol4ol benzyl(2S,3aR,7aS)octahydro1Hindole2carboxylate 29339980 145641356 hydrochloride benzyl(2S,3aS,6aS)octahydrocyclopenta[b]pyrrole2 29339980 87269872 carboxylatehydrochloride

PECONS59/10 NC/kp 22 ANNEXIII DGDDTE EN CNcode CASRN Name ethyl2amino9,10dimethoxy1,6,7,11btetrahydro4H 29339980 1012065723 pyrido[2,1a]isoquinoline3carboxylate ethyl6bromo5hydroxy1methyl2[(phenylsulfanyl)methyl] 29339980 131707249 1Hindole3carboxylate ethyl7(3aminopyrrolidin1yl)1(2,4difluorophenyl)6fluoro 29339980 105152952 4oxo1,4dihydro1,8naphthyridine3carboxylate methyl1[(2'cyanobiphenyl4yl)methyl]2ethoxy1H 29339980 139481440 benzimidazole7carboxylate methyl1tertbutyl2hydroxy1Hpyrrolo[2,3b]pyridine3 29339980 0000 carboxylate N2[(benzyloxy)carbonyl]LglutaminylLasparaginylSbenzyl 29339980 21688119 LcysteinylLprolylLleucylglycinamide tertbutyl(1S,3S,5S)3carbamoyl2azabicyclo[3.1.0]hexane2 29339980 361440677 carboxylate tertbutyl(2S)2carbamoyl2,3dihydro1Hpyrrole1 29339980 709031389 carboxylate tertbutyl[(1S)2[(1S,3S,5S)3cyano2azabicyclo[3.1.0]hex2 29339980 709031436 yl]1(3hydroxytricyclo[3.3.1.1(3,7)]dec1yl)2 oxoethyl]carbamate

PECONS59/10 NC/kp 23 ANNEXIII DGDDTE EN CNcode CASRN Name methyl2((R)3(3((E)2(7chloroquinolin2yl)vinyl)phenyl) 29334990 936359250 3(((1 (hydroxymethyl)cyclopropyl)methyl)sulfanyl)propyl)benzoate

29341000 110130886 (2Z)[(acetyloxy)imino](2amino1,3thiazol4yl)ethanoicacid

(2Z){[(1tertbutoxy2methyl1oxopropan2yl)oxy]imino}[2 29341000 68672662 (tritylamino)1,3thiazol4yl]ethanoicacid 29341000 291536351 (5Z)5(4fluorobenzylidene)1,3thiazolidine2,4dione 2aminoN(2chloro6methylphenyl)1,3thiazole5 29341000 302964245 carboxamide 3[2chloro4({4methyl2[4(trifluoromethyl)phenyl]1,3 29341000 866920243 thiazol5yl}methoxy)phenyl]1,2,4oxadiazol5(4H)one 4(2chloro4methoxy5methylphenyl)N[(1S)2cyclopropyl 29341000 752253397 1(3fluoro4methylphenyl)ethyl]5methylN(prop2yn1yl) 1,3thiazol2amine Llysine{[(2R,3R)3[4(4cyanophenyl)1,3thiazol2yl]2 (2,4difluorophenyl)1(1H1,2,4triazol1 29341000 914361458 yl)butan2yl]oxy}methyldihydrogenphosphateethanol (1:1:1)

PECONS59/10 NC/kp 24 ANNEXIII DGDDTE EN CNcode CASRN Name N(2chloro6methylphenyl)2[(6chloro2methylpyrimidin4 29341000 302964085 yl)amino]1,3thiazole5carboxamide

29341000 127660042 sodium(2Z)(2amino1,3thiazol4yl)(hydroxyimino)ethanoate

29349990 17381543 (1benzothiophen5yl)aceticacid (1R)1,2anhydro4C{(1E,3E)4[(1S,2S,3E,5R,6R,9R)5(1 carboxylato4cycloheptylpiperazin2yl)6,9dihydroxy2,6 29349990 630100902 dimethyl11oxooxacyclododec3en1yl]penta1,3dien1yl} 3,5dideoxy1[(2R,3S)3hydroxypentan2yl]Derythropentitol (2R)3'Hspiro[4azabicyclo[2.2.2]octane2,2'furo[2,3 29349990 220099912 b]pyridine] (2R)3'Hspiro[4azabicyclo[2.2.2]octane2,2'furo[2,3 29349990 220100812 b]pyridine](S,S)2,3dihydroxybutanedioate (2R,3R,4R,5R)2(4amino5fluoro2oxopyrimidin1(2H)yl)2 29349990 161599468 fluoro5methyltetrahydrofuran3,4diyldiacetate (2R,3S,4R)5(4amino2oxopyrimidin1(2H)yl)2azido2 29349990 690270656 {[(2methylpropanoyl)oxy]methyl}tetrahydrofuran3,4diylbis(2 methylpropanoate)hydrochloride

PECONS59/10 NC/kp 25 ANNEXIII DGDDTE EN CNcode CASRN Name (3{[(2R,3S)2{(1R)1[3,5bis(trifluoromethyl)phenyl]ethoxy} 3(2fluorophenyl)morpholin4yl]methyl}5oxo2,5dihydro 29349990 265121048 1H1,2,4triazol1yl)phosphonicacid1deoxy1 (methylamino)Dglucitol(1:2) (3S)10[1(acetylamino)cyclopropyl]9fluoro3methyl7oxo 29349990 163680806 2,3dihydro7H[1,4]oxazino[2,3,4ij]quinoline6carboxylicacid (3S)N,Ndimethyl3(naphthalen1yloxy)3(thiophen2 29349990 132335467 yl)propan1amine (3S,6R,9S,12R,15S,18R,21S,24R)6,18dibenzyl 4,10,12,16,22,24hexamethyl3,9,15,21tetrakis(2methylpropyl) 29349990 133413704 1,7,13,19tetraoxa4,10,16,22tetraazacyclotetracosane 2,5,8,11,14,17,20,23octone (5R)3(6{2[(2,6dichlorobenzyl)oxy]ethoxy}hexyl)5(2,2 29349990 503068368 dimethyl4H1,3benzodioxin6yl)1,3oxazolidin2one (5R)5(2,2dimethyl4H1,3benzodioxin6yl)1,3oxazolidin2 29349990 452339730 one (6R)6cyclopentyl6[2(2,6diethylpyridin4yl)ethyl]3[(5,7 29349990 877130284 dimethyl[1,2,4]triazolo[1,5a]pyrimidin2yl)methyl]4hydroxy 5,6dihydro2Hpyran2one 29349990 132335445 (S)3(dimethylamino)1(thiophen2yl)propan1ol

PECONS59/10 NC/kp 26 ANNEXIII DGDDTE EN CNcode CASRN Name {(2R,3S,4R,5R)2azido5(2,4dioxo3,4dihydropyrimidin 29349990 812647806 1(2H)yl)3,4bis[(phenylcarbonyl)oxy]tetrahydrofuran2 yl}methyl3chlorobenzoate 1(1{4[2(4fluorophenyl)1,3dioxolan2yl]butyl}1,2,3,6 29349990 00000 tetrahydropyridin4yl)1,3dihydro2Hbenzimidazol2one 1(1ethoxyethyl)4(4,4,5,5tetramethyl1,3,2dioxaborolan2 29349990 1029716446 yl)1Hpyrazole 1[(2R,5S)5(hydroxymethyl)2,5dihydrofuran2yl]5 29349990 165172601 methylpyrimidine2,4(1H,3H)dione1methylpyrrolidin2one (1:1) 1[3(2benzo[b]thien5ylethoxy)propyl]3azetidinol(2Z)2 29349990 519187974 butenedioate(1:1) 1{[(2R,3S)2(2,4difluorophenyl)3methyloxiran2yl]methyl} 29349990 127000902 1H1,2,4triazole 2({[(1R,3S)3{[2(3methoxyphenyl)5methyl1,3oxazol4 29349990 710281337 yl]methoxy}cyclohexyl]oxy}methyl)6methylbenzoicacid 29349990 96803304 2(1benzothiophen5yl)ethanol 2[({4[(2,2dimethyl1,3dioxan5yl)methoxy]3,5 29349990 913695008 dimethylpyridin2yl}methyl)sulfinyl]1Hbenzimidazole,sodium salt(1:1)

PECONS59/10 NC/kp 27 ANNEXIII DGDDTE EN CNcode CASRN Name 2{[(3aR,4S,6R,6aS)6{[5amino6chloro2 29349990 376608741 (propylsulfanyl)pyrimidin4yl]amino}2,2dimethyltetrahydro 3aHcyclopenta[d][1,3]dioxol4yl]oxy}ethanol 2bromo1[3tertbutyl4methoxy5(morpholin4 29349990 474554488 yl)phenyl]ethanone

3(5{[4(cyclopentyloxy)2hydroxyphenyl]carbonyl}2[(3 29349990 530141721 hydroxy1,2benzoxazol6yl)methoxy]phenyl)propanoicacid

3[2(1benzothiophen5yl)ethoxy]1(3hydroxyazetidin1 29349990 519188557 yl)propan1one 29349990 519188422 3[2(1benzothiophen5yl)ethoxy]propionicacid 3{(E)2[(3R)pyrrolidin3yl]ethenyl}5(tetrahydro2Hpyran 29349990 753015428 4yloxy)pyridine 3chloro6methyldibenzo[c,f][1,2]thiazepin11(6H)one5,5 29349990 26638539 dioxide 3oxo4(2,3,5triOacetylβDribofuranosyl)3,4 29349990 499785818 dihydropyrazine2carboxamide

29349990 356782848 3oxo4(βDribofuranosyl)3,4dihydropyrazine2carboxamide

4[3hydroxy3phenyl3(thiophen2yl)propyl]4 29349990 6504570 methylmorpholin4iummethylsulfate

PECONS59/10 NC/kp 28 ANNEXIII DGDDTE EN CNcode CASRN Name 4[4({3[(4deoxy4fluorobDglucopyranosyl)oxy]5(propan 29349990 871484321 2yl)1Hpyrazol4yl}methyl)phenyl]N[1,3dihydroxy2 (hydroxymethyl)propan2yl]butanamide 29349990 166964096 4chloro3methyl1,2oxazol5amine 4nitrobenzyl(6R,7R)7amino8oxo3[(2S)tetrahydrofuran2 29349990 655233393 yl]5thia1azabicyclo[4.2.0]oct2ene2carboxylate hydrochloride 29209085 89729099 5,7dioxa6thiaspiro[2.5]octane6oxide 5[4[[3chloro4[(3fluorophenyl)methoxy]phenyl]amino]6 29349990 388082755 quinazolinyl]2furancarboxaldehyde4 methylbenzenesulfonate(1:1) 29349990 4923879 5bromo1benzothiophene

29349990 947408959 6(bromomethyl)2triphenylmethyl1,2benzisoxazol3(2H)one

29349990 947408948 6methyl2trityl1,2benzoxazol3(2H)one diphenylmethyl(2R)3methyl2[(1R,5S)3(4methylphenyl)7 29349990 67978056 oxo4oxa2,6diazabicyclo[3.2.0]hept2en6yl]but3enoate DNA(syntheticplasmidvectorpCORhumaninterferonbeta 29349990 1001859466 signalpeptidefusionproteinwith21154humanacidicfibroblast growthfactorspecifying)

PECONS59/10 NC/kp 29 ANNEXIII DGDDTE EN CNcode CASRN Name DNA,d(TspCGspTspCGspTspTspTspTspGspA 29349990 665058786 spCGspTspTspTspTspGsp TspCGspTspT) methyl(5R,7S,10S)10tertbutyl15,15dimethyl3,9,12trioxo 6,7,9,10,11,12,14,15,16,17,18,19dodecahydro1H,5H2,23:5,8 29349990 923591064 dimethano4,13,2,8,11benzodioxatriazacyclohenicosine7(3H) carboxylate 29349990 59337927 methyl3(chlorosulfonyl)thiophene2carboxylate methyl3[5[4(cyclopentyloxy)2hydroxybenzoyl]2[(2 29349990 947409010 triphenylmethyl1,2benzisoxazol3(2H)on 6yl)methoxy]phenyl]propionate 29349990 85006311 methyl3amino4methylthiophene2carboxylate N(5chloro1,3benzodioxol4yl)7[2(4methyl1 29349990 893428723 piperazinyl)ethoxy]5[(tetrahydro2Hpyran4yl)oxy]4 quinazolinamine(2E)2butenedioate(1:2) N,N',N''(boroxin2,4,6triyltris{[(1S)3methylbutane1,1 29349990 390800881 diyl]imino[(2S)1oxo3phenylpropane1,2diyl]})tripyrazine2 carboxamide 29349990 112913947 N{[4(4fluorobenzyl)morpholin2yl]methyl}acetamide

PECONS59/10 NC/kp 30 ANNEXIII DGDDTE EN CNcode CASRN Name

29349990 120788036 S[(1R,3S)1oxidotetrahydrothiophen3yl]ethanethioate

(1R,2R)1[(cyclopropylsulfonyl)carbamoyl]2 29350090 1198178652 ethylcyclopropanaminium4methylbenzenesulfonate (2R)3(benzylsulfanyl)N[(2S)1{[(2S,3S)1hydrazinyl3 methyl1oxopentan2yl]amino} 29350090 39570962 3(4hydroxyphenyl)1oxopropan2yl]2{[(4 methylphenyl)sulfonyl]amino}propanamide 1[(4methylphenyl)sulfonyl]1,2,3,4tetrahydro5H1 29350090 24310369 benzazepin5one 2(cyclohexylmethyl)N{2[(2S)1methylpyrrolidin2yl]ethyl} 29350090 0000 1,2,3,4tetrahydroisoquinoline7sulfonamidedi[(2E)but2 enedioate]hydrate 3[(methylsulfonyl)amino]2phenylN[(1S)1 29350090 941690557 phenylpropyl]quinoline4carboxamide 29350090 6973097 5amino2methylbenzenesulfonamide 7chloro1[(4methylphenyl)sulfonyl]1,2,3,4tetrahydro5H1 29350090 193686769 benzazepin5one 29350090 123664846 N(5methoxy2phenoxyphenyl)methanesulfonamide N[4(Nformylglycyl)5hydroxy2 29350090 149457034 phenoxyphenyl]methanesulfonamide N[4(Nformylglycyl)5methoxy2 29350090 149456984 phenoxyphenyl]methanesulfonamide

PECONS59/10 NC/kp 31 ANNEXIII DGDDTE EN CNcode CASRN Name N{2[(4hydroxyphenyl)amino]pyridin3yl}4 29350090 141450488 methoxybenzenesulfonamidehydrochloride N{5[(diphenylphosphoryl)methyl]4(4fluorophenyl)6 29350090 289042100 (propan2yl)pyrimidin2yl}Nmethylmethanesulfonamide (4S)4ethyl4hydroxy1Hpyrano[3',4':6,7]indolizino[1,2 29399900 7689034 b]quinoline3,14(4H,12H)dione 29399900 477292 colchicoside 29400000 604693 1,2,3,4,6pentaOacetylβDglucopyranose

29400000 647834159 2(4methoxybenzyl)thiophen3ylβDglucopyranoside

(6R,7R)7({N[(4ethyl2,3dioxopiperazin1yl)carbonyl]D threonyl}amino)3{[(1methyl1Htetrazol5 29419000 76610929 yl)sulfanyl]methyl}8oxo5thia1azabicyclo[4.2.0]oct2ene2 carboxylicacid poly(oxy1,2ethanediyl),αhydroωmethoxy,diesterwith21N6, 21'N6[[(N2,N6dicarboxyLlysylβalanyl)imino]bis(1oxo2, 1ethanediyl)]bis[NacetylglycylLleucylLtyrosylLalanylL 39072099 913976279 cysteinylLhistidylLmethionylglycylLprolylLisoleucylL threonyl3(1naphthalenyl)LalanylLvalylLcysteinylL glutaminylLprolylLleucylLarginylNmethylglycylL lysinamide]cyclic(6→15),(6'→15')bis(disulfide)

PECONS59/10 NC/kp 32 ANNEXIII DGDDTE EN ANNEX IV

List of pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products, to be withdrawn from the list of products receiving duty-free treatment included in Annex 6 to Annex I to Regulation (EEC) No 2658/87 due to their transfer to the list of products receiving duty-free treatment included in Annex 3 to Annex I to Regulation (EEC) No 2658/87

CNcode CASRN Name 29153900 17alphahydroxy3,20dioxopregna4,9(11)diene21ylacetate 7753608 seeanecortave(INN) 29372900 4(nitrooxy)butyl(2S)2(6methoxy2naphthyl)propanoate 29209085 163133435 seenaproxcinod(INN) 2(2chlorophenyl)2hydroxyethylcarbamate 29242998 194085751 seecarisbamate(INN) 3ethyl5methyl2[(2aminoethoxy)methyl]4(2 chlorophenyl)6methyl1,4dihydropyridine3,5dicarboxylate 29333999 103129824 seelevamlodipine(INN)

PECONS59/10 NC/kp 1 ANNEXIV DGDDTE EN CNcode CASRN Name Nmethyl2{[3((E)2pyridin2ylvinyl)1Hindazol6 yl]sulfanyl}benzamide 29333999 319460850 seeaxitinib(INN) N(2chloro6methylphenyl)2({6[4(2 hydroxyethyl)piperazin1yl]2methylpyrimidin4 29341000 302962498 yl}amino)thiazole5carboxamide seedasatinib(INN) (2R,5S)4amino5fluoro1[2(hydroxymethyl)1,3oxathiolan 5yl]pyrimidin2(1H)one 29349990 143491570 seeemtricitabine(INN) (2S)2[(S)(2ethoxyphenoxy)phenylmethyl]morpholine 29349990 98819762 seeesreboxetine(INN) (2S)2methoxy3{4[2(5methyl2phenyl1,3oxazol4 yl)ethoxy]1benzothiophen7yl}propanoicacid 29349990 475479346 seealeglitazar(INN) 2(2furyl)7(2{4[4(2methoxyethoxy)phenyl]piperazin1 yl}ethyl)7Hpyrazolo[4,3e][1,2,4]triazolo[2,3c]pyrimidin5 29349990 377727872 amine seepreladenant(INN)

PECONS59/10 NC/kp 2 ANNEXIV DGDDTE EN CNcode CASRN Name 2{7fluoro2oxo4[2(4thieno[3,2c]pyridin4ylpiperazin1 yl)ethyl]quinolin1(2H)yl}acetamide 29349990 189003927 seetrelanserin(INN) 4amino5fluoro1[(2R,5S)5(hydroxymethyl)2,5 dihydrofuran2yl]pyrimidin2(1H)one 29349990 134379774 seedexelvucitabine(INN) potassium4[N(2fluorobenzyl)carbamoyl]1methyl2[1 methyl1(5methyl1,3,4oxadiazole2carboxamido)ethyl]6 29349990 518048050 oxo1,6dihydropyrimidine5olate seeraltegravir(INN) 4[5(4fluorophenyl)3(trifluoromethyl)pyrazol1yl]benzene 1sulfonamide 29350090 170569887 seemavacoxib(INN) N(3methoxy5methylpyrazin2yl)2[4(1,3,4oxadiazol2 yl)phenyl]pyridine3sulfonamide 29350090 186497074 seezibotentan(INN)

PECONS59/10 NC/kp 3 ANNEXIV DGDDTE EN