Document ID: 31997R0467

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31997R0467
Official Journal L 071 , 13/03/1997 P. 0001 - 0015
Ir-Regolament tal-Kunsill (KE) Nru 467/97tat-3 ta' Marzu 1997li jipprovdi għal trattament liberu mid-dazju għal ingredjenti speċifikati attiva farmaċewtikament li jkollhom "isem internazzjonali mhux proprjetarju" (INN) mill-Organiżżazzjoni Dinjija tas-Saħħa u prodotti speċifikati wżati għall-manifattura ta' farmaċewtiċi kompluti u li jirtira t-trattament liberu mid-dazju peress li prodotti farmaċewtiċi minn ċerti INNs li l-użu ewlieni tagħhom mhux farmaċewtikuIL-KUNSILL TA' L-UNJONI EWROPEA,Wara li kkunsidra t-Trattat li jistabbilixxi l-Komunità Ewropea, u partikolarment l-Artikolu 113 tiegħu,Wara li kkunsidra l-proposta tal-Kummissjoni,Billi, matul in-negozjati tas-Sensiela Urugwajana l-Komunità u numru ta' pajjiżi ddiskutew it-trattament liberu mid-dazju tal-prodotti farmaċewtiċi;Billi l-parteċipanti ta' dawk id-diskussjonijiet ikkonkludew li barra l-addizzjoni tal-prodotti li jaqgħu taħt is-Sistema ta' l-Armonizzazzjoni (HS) Kapitolu 30 u l-Intestaturi tal-HS 2936, 2937, 2939 u 2941, it-trattament liberu mid-dazju għandu jingħata lill-ingredjenti nnominati attivi farmaċewtikament li għandhom "isem internazzjonali mhux proprjetarju" (INN) mill-Organizzazzjoni Dinjija tas-Saħħa kif ukoll melħ, esters u hydrates speċifikati tat-tali INNs, u wkoll għall-prodotti nnominati wżati għall-produzzjoni u l-manifattura tal-prodotti kompluti;Billi r-riżultati tad-diskussjonijiet, kif preżentati fir-rekord tad-diskussjonijiet, kienu nkorporati fl-iskedi tat-tariffi tal-parteċipanti annessi mal-Protokoll Marrakesh mal-GATT 1994;Billi huma wkoll ikkonkludew li r-rappreżentanti tal-membri tal-WTO li għamlu parti mir-rekord tad-diskussjonijiet għandhom jiltaqgħu taħt l-awspiċi tal-Kunsill għall-Kummerċ tal-Merkanzija ta' l-WTO, normalment mill-anqas kull tlett snin – biex jirrevedu kemm hu kopert il-prodott bil-għan li jinkludu, b'kunsens, prodotti farmaċewtiċi addizzjonali għall-eliminazzjoni tat-tariffi;Billi t-tali l-ewwel reviżjoni saret bil-konklużjoni li ċertu numru ta' INNs addizzjonali u prodotti wżati għall-produzzjoni u l-manifattura ta' farmaċewtiċi kompluti għandhom ingħataw trattament liberu mid-dazju u li l-lista tal-prefissi u suffissi speċifikati għall-melħ u l-esters ta' l-INNs għandhom ikunu espanduti;Billi fil-kuntest tar-reviżjoni kien konkluż li huwa xieraq li tkun irranġata s-sitwazzjoni rigward ċerti INNs li l-użu ewlieni tagħhom ma kienx farmaċewtiku u li bi żball kienu fost dawk l-INNs li diġa' qed jirċievu trattament liberu mid-dazju,ADOTTAT DAN IR-REGOLAMENT:Artikolu 1Mill-1 ta'April 1997 il-Komunità għandha wkoll tagħti t-trattament liberu mid-dazju għall-INNs imniżżla fl-Anness I kif ukoll għall-melħ, l-esters u l-hydrates tat-tali prodotti.Artikolu 2Mill-1 ta'April 1997 il-Komunità għandha wkoll tagħti trattament liberu mid-dazju għall-prodotti wżati fil-produzzjoni u l-manifattura tal-prodotti farmaċewtiċi mniżżla fl-Anness II.Artikolu 3Mill-1 ta'April 1997 il-prefissi u s-suffissi speċifikati ta' l-INNs eliġibbli għat-trattament liberu mid-dazju għandhom ukoll jinkludu dawk imniżżla fl-Anness III.Artikolu 4Mill-1 ta'April 1997 il-prodotti mniżżla fl-Anness IV flimkien mal-melħ, l-esters u l-hydrates tat-tali prodotti m'għandhomx jibbenefikaw aktar mit-trattament liberu mid-dazju.Artikolu 5Dan ir-Regolament jidħol fis-seħħ fil-ġurnata ta' wara dik tal-pubblikazzjoni tiegħu fil-Ġurnal Uffiċjali tal-Komunitajiet Ewropej.Dan ir-Regolament għandu jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha.Magħmul fi Brussell, fit-3 ta' Marzu 1997.Għall-KunsillIl-PresidentM. De Boer--------------------------------------------------ANNESS IINNs addizzjonali li għandhom jirċievu trattament bla dazjuKodiċi NM | SAK RN | Isem |28444030 | 113716-48-6 | Iolopride (123 I) |142481-95-6 | Technetium (99 m Tc) furifosmin |28469000 | 131069-91-5 | Gadoversetamide |135326-11-3 | Gadoxetic aċidu |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 aċidu |124351-85-5 | Incadronic aċidu |63132-39-8 | Olpadronic aċidu |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 aċidu |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 | Ilomastat |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 | Deriotivir |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 | Rocepaf ant |132418-35-0 | Setipaf ant |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 |--------------------------------------------------ANNESS IIIntermedji farmaċewtiċi addizzjonali, i.e. komposti użati għall-manifattura ta' prodotti farmaċewtiċi raffinati, li għandhom jirċievu trattament bla dazjuKodiċi NM | SAK RN | Isem |28433000 | 12192-57-3 | (alpha-D-glucopyranosylthio) deheb |29036990 | 42074-68-0 | 1-klorin-2-(chlorodiphenylmethyl) benżin |76283-09-5 | alpha,4-dibromo-2-fluorotoluene |29062990 | 104265-58-9 | 2-S,2R)-6-fluoro-2-hydroxy-l-isopropyl-1,2,3,4-tetrahydro-2-naphthylħ ethyl p-toluenesulfonate |29072990 | 700-13-0 | 2,3,5-trimethyihydroquinone |29095090 | 63659-16-5 | 4-ġ2(cyclopropylmethoxy) ethyħ phenol |29144090 | 80-75-1 | 1 1-alpha-hydroxypregn-4-ene-3,20-dione |29145000 | 2107-69-9 | 5,6-dimethoxyindan-1-onee |24916-90-3 | 9-beta,11-beta-epoxy-17,21-dihydroxy-l6-alpha-methylpregna-1,4-diene-3,20-dione |29147090 | 83881-08-7 | 21-chloro-9-beta,1 1-beta-epoxy-17-hydroxy-16-alpha-methylpregna-1,4-diene-3,20-dione |29153990 | 979-02-2 | 20-oxopregna-S,16-dien-3-beta-yl acetate |29159020 | 638-41-5 | pentyl chioroformate |29163900 | 49708-81-8 | Transitu-4-(p-chlorophenyl)cyclohexanecarboxylic aċidu |29171990 | 48059-97-8 | (E)-oct-4-ene-1,8-dioic aċidu |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 aċidu |29181700 | 4358-88-7 | DL-mandelate ethyl |29181980 | 56188-04-6 | (1 R,3R,5S)-3,5-dihydroxy-2-ġ(E)-(3S)-3-hydroxyoct-1-enylħcyclopentylĦacetic aċidu |29182990 | 167678-46-8 | 3-chloroformyl-o-tolyl acetate |29183000 | 56105-81-8 | (R)-2-ġ3-benzoylphenyl) propionic aċidu |22161-86-0 | (RS)-2-ġ3-benzoylphenyl) propionic aċidu |78834-75-0 | enthyl 7-chloro-2-oxoheptarioate |1944-63-4 | 3-ġ(3aS,4S,7aS)-7a-methyl-1,5-dioxooctahydro-1H-inċiż-4-ylħ propionic acid |39562-17-9 | methyl 2-ġ3-nitrobenzylidene)-3-oxobutyrate |29189090 | 26159-31-9 | (RS)-2-(6-methoxy-2-naphthyl)propionic aċidu |105560-93-8 | methyl (2R,3S)-2,3-epoxy-3-(4-methoxyphenyl) propionate |40098-26-8 | Methyl 7-ġ(3RS)-3-hydroxy-5-oxocyclopent-1-enylħheptaneate |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'-ġ2-(dimethylamino) ethoxyħ-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-onee |29224970 | 37441-29-5 | 5-amino-2,4,6-triiodoisophthaloyl dichloride |42854-62-6 | benzyl L-alaninate--p-toluenesulfonic aċidu (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 aċidu (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-L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysine |29242990 | 40188-45-2 | 3'-acethyl-4'-hydroxybutyranilide |1149-26-4 | N-(benzylxycarbonyl)-L-valine |116661-86-0 | (2S,3S)-3-(tert-butoxycarbonylamino)-2-hydroxy-4-phenylbutyric aċidu |144163-85-9 | tert-butyl ġ(1S,3S,4S)-4-amino-1-benzyl-3-hydroxy-5-phenylpentylħ carbamate |149451-80-9 | tert-butyl ġ S,2S)-1-benzyl-2,3-dihydroxypropylħ carbamate |98737-29-2 | tert-butyl Ġ(S)-alpha-ġ(S)-oxiranylħphenethylĦcarbamate |0-00-0 | 2-chloro-N--ġ2-(2-chlorobenzoyl)-4-nitrophenylħ acetamide |125971-96-2 | 2-ġalpha-(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-Ġ4-ġbis(2-chloroethy)aminoħphenylħ-2-phthalimidopropionate hydrochloride |29269080 | 58311-73-2 | (Z)-(2-cyanovinyl)trimethylammonium p-toluenesulfonate |133481-10-4 | ethyl (1-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-(benzylxycarbonyl)-S-phenyl-L-cysteine |29309070 | 159878-02-1 | benzyl (1 R,2S)-3-chloro-2-hydroxy-1-(phenylthiomethyl)propylcarbamate |136511-43-8 | ethyl N-Ġ2-ġ(acethylthio)methylħ-3-(o-tolyl)-1-oxopropyl)-L-methionate |29321900 | 97148-39-5 | ammonium (Z)-2-methoxyimino-2-(2-furyl)acetate |29322980 | 517-23-7 | alpha-acethyl-gamma-butyrolactone |6559-91-7 | 4'-demethylepipodophyllotoxin |39521-49-8 | (3aR,4bS,4R,4aS,SaS)-4-(S,S-dimethyl-1,3-dioxolan-2-yl) hexahydrocyclopropaġ3,4ħ cyclopentaġ1,2-bħfuran-o-2(3H)-onee |39746-01-5 | (3aR,4R,5R,6aS)-4-formyl-2-oxohexahydro-2H-cyclopenta (b)furan-5-ylu benzoate |976-70-5 | 3-oxopregn-4-ene-21,17-alpha-carbolactone |29329950 | 32981-86-5 | 10-deacethylbaccatin III |29329970 | 7512-17-6 | 2-acetamido-2-deoxy-beta-D-glucopyranose |79944-37-9 | Transitu-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol |125971-94-0 | tert-butyl ġ (4R,6R)-6-(cyanomethyl)-2,2-dimethyl-1,3-dioxolan-4-yl) acetate |467-55-0 | 3-beta-hydroxy-5-alpha-spirostan-12-onee |533-31-3 | 3,4-(methylenedioxy)phenol |29331190 | 6150-97-6 | magnesium bisġ(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)methylamino)methane-o-sulfonate |29331990 | 27511-79-1 | 3-aminopyrazole-4-carboxamide hemisulfate |29332990 | 4897-25-0 | S-chloro-1-methyl-4-nitroimidazole |29333995 | 142057-79-2 | (RS)-2ġ(1-benzyl-4-piperidyl)methyl)-5,6-dimethoxyindan-1-one |120014-07-5 | 2-ġ(1-benzyl-4-piperidyl)methylene)-5,6-dimethoxyindan-1-one |6935-27-9 | benzyl(2-pyridyl)amine |87848-95-1 | 6-bromo-2-pyridyl-p-tolyl ketone |32998-95-1 | N-(tert-butyl)-3-methylpirydine-2-carboxamide |84449-80-9 | 1-ġ2-(4-carboxyphenoxyħethyl)piperidinium chloride |83949-32-0 | 4-carboxy-4-phenylpiperidinium p-toluenesulforiate |38092-89-6 | 8-chloro-6,1 1-dihydro-1 1-(1-methyl-4-piperidylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pirydine |31255-57-9 | 3-(2-ġ3-chlorophenyl)ethyl)pyridine-2-carbonitrile |107256-31-5 | 3-ġ2-ġ3-chlorophenyl)ethylħ-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-(1-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-i-yl)-1-(p-tolyl)propan-i-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-dihydro-o-quinoline-3-carboxylic aċidu |86393-33-1 | 7-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic aċidu |112811-72-0 | 1-cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic aċidu |98349-25-8 | ethyl 1-cyclopropyl-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate |29334090 | 159878-04-3 | benzyl (1S,2S)-3-ġ3S,4aS,8aS)-3-tert-butylcarbamoylperhydro-2-isoquinolyħ-2-hydroxy-1-(phenylthio o methyl) propylcarbamate |159989-64-7 | (3S,4aS,8aS)-N-(tert-butyl)-2-ġ(2S,3S)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylthio)butylħ o perhydroisoquinoline-3-carboxamide |159989-65-8 | (3S,4aS,8aS)-N-(tert-butyl)-2-ġ(2S,3S)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylthio)butyl) perhydroisoquinoline -3-carboxamide—methanesulfonic aċidu (1:1) |120578-03-2 | 3-ġ(E)-2-(7-chloro-2-quinolyl)vinyl)benzaldehyde |1087-69-0 | (9S,13S,14S)-3-methoxymorphinan hydrochloride |64228-78-0 | pentamethylene bis 3-Ġ3-(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-1,2,3,4-tetrahydro-2-isoquinolyl) propionateĦ--oxalic aċidu (1:2) |29335970 | 75128-73-3 | 2-ġ(2-acetamido-6-oxo-6,9-dihydro-1H-purin-9-yl)methoxyħethyl acetate |3056-33-5 | N-(9-acethyl-6-oxo-6,9-dihydro-1H-purin-2-yl)acetamide |10310-21-1 | 2-amino-6-chloropurine |124832-31-1 | 2-ġ(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxyħethylN-(benzyloxycarbonyl)-L-valinate |150378-17-9 | (2R,4S)-2-benzyl-5-(2-(tert-butylcarbamoyl)-4-(3-pyridylmethyl)piperazin-1-ylħ-4-hydroxy-N-ġ(1S,2R)-o2-hydroxyindan-1–yl)valermide |157810-81-6 | (2R,4S)-2-benzyl-5-ġ2-(tert-butylcarbamoyl)-4-(3-pyridylmethyl)piperazin-1-ylħ-4-hydroxy-N-ġ(1S,2R)-2-hydroxyindan-1-ylħvalermide 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-6,7,8,9,10,12-hexahydroazepino(2,1-b)quinazoline hydrochloride |41202-77-1 | 1-(2,3-dichlorophenyl)piperazine hydrochloride |56177-80-1 | 2-ethoxy-5-fluoropyrimidin-4(1H)-one |112733-45-6 | ethyl (7-chloro-2,4-dioxo-1,2,3,4-tetrahydroquinazolin-1-yl)acetate |59703-00-3 | 4-ethyl-2,3-dioxopiperazin-1-carbonylu 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(1,2-a)pirazin-7-yl methanol |2210-93-7 | chloride 1-phenylpiperazinium |111641-17-9 | 4-(piperazin-1-yl)-2,6-bis(pyrrolidin-1-yl)pyrimidine |68-94-0 | purin-6(1H)-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-ġ(R)-1-(tert-butyldimethylsilyloxy)ethylħ-4-ġ(1R,3S)-3-methoxy-2-oxocyclohexyl)azetidin-2-one |141646-08-4 | 1-Ġġ(cyclohexyloxy)carbonyl)oxyĦethyl-1-(1-hydroxyethyl)-5-methoxy-2-oxo-1,2,5,6,7,8,8a,8b-octahydroazeto o ġ2,1 –aħisoindole-4-carboxylate |132127-34-5 | (3R,4S)-3-hydroxy-4-phenylazetidin-2-one |75363-99-4 | p-nitrobenzyl (2R,5R,6S)-6-ġ(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-1,2,5,6,7,8,8a,8b-octahydroazeto(2,1-a)isoindole-4-carboxylate |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-1H-1,4-benzodiazepin-2-ylmethylħ ammonium bis(maleate) |59467-69-5 | 8-chloro-6-(2-fluorophenyl)-1-methyl-3a,4-dihydro-3H-imidazo(1,5-a)(1,4)benzodiazepine |59469-63-5 | 7-chloro-5-(2-fluorophenyl)-3-methyl-2-(nitromethylene)-2,3-dihydro-1H-1,4-benzodiazepine 4-oxide |59467-63-9 | 7-chloro-5-(2-fluorophenyl)-2(nitromethylene)-2,3-dihydro-1H-1,4-benzodiazepine |29339095 | 130404-91-0 | N-ġ(R)-2-(Ġ(R)-2-ġ(2-adamantyloxycarbonyl)aminoħ-3-(1H-indol-3-yl)-2-methyl-1-oxopropylĦamino)-1-phenylethylħsuccinamic aċidu-1-deoxy-1-methylamino-D-glucitol (1:1) |122536-48-5 | 3-ġ(S)-3-(L-alanylamino)pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine–3-carboxylic aċidu hydrochloride |122536-91-8 | 7-Ġ(S)-3-ġ(S)-2-(tert-butoxycarbonylamino)-1-oxopropylamino)pyrrolidin-1-ylĦ-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic aċidu |134575-17-0 | tert-butyl meso-3-azabicyclo(3,1,0)hex-6-ylcarbamate |122536-66-7 | tert-butyl Ġ(S)-1-methyl-2-oxo-2-ġ(S)-pyrrolidin-3-ylaminoħ ethylĦcarbamate |140629-77-2 | tert-butyl ġ(RS)-pyrrolidin-3-yl)carbamate |100361-18-0 | 7-chloro-1-cycopro?yl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic aċidu |38150-27-5 | 5-chloro-2-ġ3-(hydroxymethyl)-5-methyl-4H-1,2,4-triazol-4-ylħbenazophenone |36916-19-5 | 5-chloro-2-ġ3-methyl-4H-1,2,4-triazol-4-ylħbenazophenone |54196-62-2 | 2',5-dichloro-2-ġ3-(hydroxymethyl)-5-methyl-4H-1,2,4-triazol-4-yħbenazophenone |54196-61-1 | 2',5-dichloro-2-(3-methyl-4H-1,2,4-triazol-4-yl)benazophenone |141113-28-2 | (E)-(+)-2-(2,4-difluorophenyl)-1-Ġ3-ġ4-(2,2,3,3-tetrafluoropropoxy)styrylħ-1Η-1,2,4-triazol-1-ylĦ-3-(1H-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 | dimethylĠ2-(5-(1H-1,2,4-triazol-1-ylmethyl)indol-3-yl)ethylĦamine |122665-86-5 | ethyl ġ3-(cyanomethyl)-4-oxo-3,4-dihydrophtalazin-1-ylħacetate |41340-36-7 | 2-(7-ethyl-1H-indol-3-yl)ethanol |95885-13-5 | 5-ethyl-4-(2-phenoxyethyl)-4H-1,2,4-triazol-3(2H)-one |96107-94-7 | ethyl 1H-tetrazole-5-carboxylate, sodium salt |96034-57-0 | Transitu-4-hydroxy-1-(4-nitrobenzyloxycarbonyl)-L-proline |160194-26-3 | 2-iodo-4-(1H-1,2,4-triazol-1-ylmethyl)aniline |66635-71-0 | isopropyl 2,3-dihydro-1H-pyrrolizine-1-carboxylate |4928-88-5 | methyl 1H-1,2,4-triazole-3-carboxylate |0-00-0 | 1,4,7,1 0-tetraazacyclododecane-1,4,7-triacetic aċidu sulfate |112193-77-8 | 1,4,7,1 0-tetraazoniacyclododecane bis(sulfate) |3641-08-5 | 1H-1,2,4-triazole-3-carboxamide |4928-87-4 | 1?-1-1,2,3-triazole-3-carboxylic aċidu |6969-71-7 | 1,2,4-triazoloġ4,3-aħpyridin-3(2H)-one |29341000 | 171485-87-3 | 2-ġ4-(2-amino-4-oxo-4,5-dihydrothiazol-5-ylmethylħphenoxymethyl)-2,5,7,8-tetramethylchroman-6-yl acetate |65872-41-5 | (Z)-2-(2-aminothiazol-4-yl)-2-methoxyiminoaetic aċidu |64486-18-6 | (Z)-2-(2-(chloroacetamido)thiazol-4-yl)-2-(methoxyimino)acetic aċidu |76823-93-3 | 1-Ġ4-ġ(2-cyanoethyl)thiomethylħthiazol-2-ylĦquanidine |139340-56-0 | Ġ5-ġ(Z)-3,5-di(tert-butyl)-4-hydroxybenzylidene)-4-oxo-4,5-dihydrothiazol-2-ylĦammonium methane 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-ġ2-(tritylamino)thiazol-4-ylħacetic aċidu |154212-59-6 | 4-nitrophenyl thiazol-5-ylmethyl carbonate hydrochloride |38585-74-9 | thiazol-5-ylmethanol |155213-67-5 | thiazol-5-ylmethyl (1S,2S,4S)-1-benzyl-2-hydroxy-4-Ġ(2S)-2-ġ3-(2-isopropylthiazol-4-ylmethyl)-3-methylureido)-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-Ġ2-(4-(dibenzo(b,f)(1,4)thiazepin-11-yl)piperazin-1-yl)ethoxyĦethanol |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-Ġ5-ġ(1,4-dihydro-2-methyl-4-oxoquinazolin-6-ylmethyl)methylaminoħ-2-thenoylĦ-L-glutamic aċidu |161005-84-1 | (S)-N,N-dimethyl-(3-(2-thienyl)-3-(1–naphthyloxy)propyl)amine--phosphoric aċidu (1:1) |104795-66-6 | 3-isopropoxy-5-methoxy-N-(1H-tetrazol-5-yl)benzoġbħthiophene-2-carboxamide |104795-67-7 | 3-isopropoxy-5-methoxy-N-(1H-tetrazoI-5-olo)benzoġbħthiophene-2-carboxamide--1H-imidazole (1:1) |104795-68-8 | 3-isopropoxy-5-methoxy-N-(1H-tetrazol-5-yl)benzoġbħthiophene-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-ġ(2-aminoethyl)amino)-2-(2-diethylaminoethyl)-2H-(1)benzothiopyranoġ4,3,2-cdħindazol-8-ol |147086-81-5 | (4S,6S)-5,6-dihydro-6-methyl-4H-thienoġ2,3-bħthiopyran-4-ol 7,7-dioxide |29349098 | 58-61-7 | adenosine |1 52305-23-2 | (S)-4-(4-aminobenzyl)oxoazolidin-2-one |71420-85-4 | 7-amino-3-H-tetrazol-5-ylthiomethylħ-3-cephem-4-carboxylic aċidu, sodium salt |29706-84-1 | 3'-azido-3'-deoxy-S'-O-tritylthymidine |51762-51-7 | benzhydryl 3-hydroxy-7-(phenylacetamido)cepham-4-carboxylate |110314-42-6 | 5-ġ(benzofuran-2-ylcarbonyl)amino)indolo-2-carboxylic aċidu |131986-28-2 | 3-(4-chloro-1,2,S-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-Ġ(3-(2-dimethylaminoethyl)-1H-indol-5-iIo)methylĦoxoazolidin-2-one |110351-94-5 | (S)-4-ethyl-4-hydroxy-7,8-dihydro-1H-pyrano(3,4-f)indolizyno-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-Ġ3-(2-(4-fluorophenyl)-1,3-dioxolan-2-yl)propylĦ-4-piperidyl)-2,3-dihydro-1H-benzimidazole-2-thione |125995-03-1 | (4R,6R)-6-Ġ2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl)ethylĦ-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)-mentyl (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 aċidu |0-00-0 | (1R,2S,3S,6R)ġ(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-ġ(R)-(2-aminopropyl))-2-methoxybenzenosulfonamide |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 aċidu |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-tetrahydroisoquinolone--dibenzoyl-L-tartaric aċidu (1:1) |0-00-0 | Konċentrat intermedju miksub minn medium ta' fermentazzjoni ta' Escherichia coli mmodifikata ġenetikament, li fih fattur ta' human granulocyte-macrophage colony-stimulating uman; għall-użu fil-manifattura ta' medikamenti ta' HS Nru 30.02 |0-00-0 | Konċentrat intermedju miksub minn medium ta' fermentazzjoni ta' Escherichia coli mmodifikata ġenetikament, li fih interferon alpha-2b uman; għall-użu fil-manifattura ta' medikamenti ta' HS Nru 30.02 |0-00-0 | Konċentrati intermedji miksuba minn medium ta' fermentazzjoni ta' Micromonospora inyoensis użat għall-manifattura ta' l-antibijotiċi sisomicin (INN) u netilmicin (INN) |0-00-0 | Konċentrati intermedji miksuba minn medium ta' fermentazzjoni ta' Micromonospora purpurea użata għall-manifattura ta' l-antibijotiċi gentamicin sulfate (INNM) u isepamicin (INN) |38249095 | 0-00-0 | ethyl 7-chloro-2-oxoheptanoate, fl-għamla ta' soluzzjoni f'toluene |391190 | 162430-94-6 | 1,6-hexanediamine, polymer with 1,10-dibromodecane |39139080 | 83513-48-8 | danaparoid sodju |--------------------------------------------------ANNESS IIIŻidiet mal-lista ta' prefissi u suffissi li, flimkien ma' l-INNs, jiddeskrivu mluħ, esters jew idrati ta' INNsN-acethylglycinate 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-1-carboxylate mofetil octil olamine oxoglurate pendetide 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 |--------------------------------------------------ANNESS IVINNs li m'għandhomx jibbenefikaw iktar minn trattament bla dazjuKodiċi NM | SAK RN | Isem |29032200 | 79-01-6 | trichioroethylene |29033010 | 811-97-2 | norflurane |29035110 | 58-89-9 | lindane |29062100 | 100-51-6 | benzyl alcohol |29152900 | 82279-57-0 | zinc acetate, Bażiku |29224100 | 56-87-1 | lysine |29224290 | 56-86-0 | glutamic aċidu |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 |--------------------------------------------------

Summary:
Trattament mingħajr dazju ta’ ingredjenti attivi farmaċewtiċi speċifikati
Trattament mingħajr dazju ta’ ingredjenti attivi farmaċewtiċi speċifikati
 
SOMMARJU TA’:
IrRegolament (UE) Nru 1238/2010 – trattament mingħajr dazju ta’ ingredjenti attivi farmaċewtiċi speċifikati u sustanzi farmaċewtiċi lesti
Ir-Regolament (KE) Nru 467/97 – trattament mingħajr dazju ta’ ingredjenti u prodotti speċifikati użati fi prodotti farmaċewtiċi kompluti u li jirtira dan it-trattament għal oħrajn
X’INHU L-GĦAN TAR-REGOLAMENTI?
Ir-Regolamenti jinkorporaw fid-dritt tal-Unjoni Ewropea (UE) deċiżjonijiet mingħajr dazju għal ċerti sustanzi farmaċewtiċi u ingredjenti attivi. Dawn ittieħdu l-ewwel fiċ-Ċiklu tal-Urugwaj tan-negozjati kummerċjali internazzjonali. L-oġġetti kollha għandhom denominazzjoni internazzjonali komuni (INN)* u oħrajn ġodda ġew miżjuda mal-listi f’diversi okkażjonijiet. IrRegolament (UE) Nru 1238/2010 jaġġorna l-listi wara r-raba’ evalwazzjoni li tnediet fl-2009. Ir-Regolament tal-Kunsill (KE) Nru 467/97 jaġġorna l-listi wara l-ewwel evalwazzjoni.
PUNTI EWLENIN
Ir-Regolament (UE) Nru 1238/2010Hu jemenda l-Anness I (listi ta’ sustanzi farmaċewtiċi li jikkwalifkaw għal trattament mingħajr dazju) għar-Regolament (KEE) Nru 2658/87 li jistabbilixxi n-nomenklatura magħquda tal-UE. Dan jagħti trattament mingħajr dazju mill-1 ta’ Jannar 2011 lil:prodotti b’denominazzjoni internazzjonali komuni tal-Organizzazzjoni Dinjija tas-Saħħa (Annes I);il-lista ta’ prefissi u suffissi li, flimkien mal-INNs, jiddeskrivu l-imluħa, l-esteri jew l-idrati tagħhom li huma eliġibbli wkoll għal trattament mingħajr dazju (Anness II);Intermedjarji farmaċewtiċi użati għall-produzzjoni u l-manifattura ta’ sustanzi farmaċewtiċi lesti (Anness III). Dan ineħħi ċerti intermedjarji farmaċewtiċi mil-lista ta’ dawk li jirċievu trattament mingħajr dazju (Anness IV).Ir-Regolament (KE) Nru 467/97Dan jagħti trattament mingħajr dazju mill-1 ta’ April 1997 lil:231 ingredjent attiv farmaċewtiku speċifiku li għandu INN, flimkien mal-imluħa, l-esteri u l-idrati tagħhom (Anness I);234 prodott speċifiku użat għall-produzzjoni u l-manifattura ta’ sustanzi farmaċewtiċi lesti (Anness II). Huwa jespandi l-lista ta’ prefissi u sufissi speċifikati ta’ INNs eliġibbli billi jżid 84 isem mat-trattament mingħajr dazju (Anness III). Dan ineħħi 25 prodott - flimkien mal-imluħa, l-esteri u l-idrati tagħhom - mit-trattament mingħajr dazju peress li l-użu tagħhom kien fil-biċċa l-kbira mhux farmaċewtiku. (Anness IV).
MINN META JAPPLIKAW IR-REGOLAMENTI?
Ir-Regolament (UE) Nru 1238/2010 ilu japplika mill-1 ta’ Jannar 2011. Ir-Regolament (KE) Nru 467/97 ilu japplika mill-14 ta’ Marzu 1997.
SFOND
Matul iċ-Ċiklu tal-Urugwaj, l-aktar produtturi importanti - l-UE, l-Istati Uniti, il-Ġappun, il-Kanada, l-Iżvizzera, in-Norveġja u ċ-Ċina - qablu li jnaqqsu d-dazji fuq is-sustanzi farmaċewtiċi għal żero. Il-ftehim kopra aktar minn 6,000 prodott. Bl-iżvilupp ta’ mediċini ġodda, saru evalwazzjonijiet fl-1995–1996, fl-1998 u fl-2006, li żiedu kważi 2,400 prodott. Ir-raba’ evalwazzjoni żiedet 718 sustanza ġdida, li jġibu t-total tal-importazzjonijiet farmaċewtiċi mingħajr dazju fl-UE għal 8,619. Għal iktar informazzjoni, ara:Programm ta’ denominazzjoni internazzjonali komuni u klassifikazzjoni ta’ prodotti mediċi (Organizzazzjoni Dinjija tas-Saħħa).
TERMINI EWLENIN
Denominazzjonijiet internazzjonali komuni (INN). Magħrufa wkoll bħala ismijiet ġeneriċi, huma jidentifikaw sustanzi farmaċewtiċi jew ingredjenti farmaċewtiċi attivi. Kull INN huwa isem uniku li huwa rikonoxxut globalment u li huwa kklassifikat bħala proprjetà pubblika. L-Organizzazzjoni Dinjija tas-Saħħa taħdem mill-qrib mal-esperti tal-INN u mal-kumitati nazzjonali tan-nomenklatura biex tagħżel isem uniku li huwa aċċettat madwar id-dinja għal kull sustanza attiva li għandha tiġi kkummerċjalizzata bħala sustanza farmaċewtika.
DOKUMENTI EWLENIN
Regolament (UE) Nru 1238/2010 tal-Parlament Ewropew u tal-Kunsill tal-15 ta’ Diċembru 2010 li jemenda l-Anness I tar-Regolament tal-Kunsill (KEE) Nru 2658/87 f’dak li huwa l-forniment ta’ trattament mingħajr dazju għal ingredjenti attivi farmaċewtiċi speċifikati li għandhom “isem komuni internazzjonali” (INN_ mill-Organizzazzjoni Dinjija tas-Saħħa u prodotti speċifikati użati għall-manifattura ta’ sustanzi farmaċewtiċi lesti (ĠU L 348, 31.12.2010, pp. 36–73).
Ir-Regolament tal-Kunsill (KE) Nru 467/97 tat-3 ta’ Marzu 1997 li jipprovdi għal trattament liberu mid-dazju għal ingredjenti speċifikati attiva farmaċewtikament li jkollhom “isem internazzjonali mhux proprjetarju” (INN) mill-Organiżżazzjoni Dinjija tas-Saħħa u prodotti speċifikati wżati għall-manifattura ta’ farmaċewtiċi kompluti u li jirtira t-trattament liberu mid-dazju peress li prodotti farmaċewtiċi minn ċerti INNs li l-użu ewlieni tagħhom mhux farmaċewtiku (ĠU L 71, 13.3.1997, pp. 1–15).
DOKUMENTI RELATATI
Ir-Regolament tal-Kunsill (KEE) Nru 2658/87 tat-23 ta’ Lulju 1987 dwar in-nomenklatura tat-tariffa u l-istatistika u dwar it-Tariffa Doganali Komuni ta’ Dwana (ĠU L 256, 7.9.1987, pp. 1–675).
L-emendi suċċessivi għar-Regolament (KEE) Nru 2658/87 ġew inkorporati fit-test oriġinali. Din il-verżjoni konsolidata għandha valur dokumentarju biss.
l-aħħar aġġornament 14.12.2021