Document 5LLQZnYm595zdkqVgw0o8GJ8J

Pharmaceutical Supply Chain -- Current Applicability of REACH! & CLP? Drug Substance Drug Product Finished Medi ross Manufacturing* Formulation & Packaging KvPramas gst i : Sl oo Pairs 2 Medicin ------ pir Hin ee avai [IT rr Retr pese er om Sok Fresno Rs Wh Seoe REACH LP. OS 53 eter ie on sas Res en pesmi || rs icpasne || _-- nese ge as emr e oe re ere res a ew | meme | oes = Bee | men] osm Ser rer Cr Co = Bares pee i Glossary of Terms Raw Material API Starting Material `isAnroatwimnactoerrpioarlaitea dassubastsaignnciefiocfanmtisxttruurcetuorfalsufbrsatgamnecnetsntthoathseuisreudctnurtehoef ptrhoddrucutgionsupbrsotcaenscseo(fe.ag.drpurgocseusbsstsaonlcveen,t,buctatwahliycsth reagent). => Pharmaceutical manufacturers are fypicaly the downstream user of aw materials mStaatretriinaglmsahtoeurlidablsedaetserumibneswhtoefradeentfhiceneAedPIch(eAcmtiicvaelpphraorpmearcteiuestiacnadl sitnrgurcetduireen.t)Nmoann-uifoalcattuerdinigntperromceedsisatbeesgianrse. usAusatlalrytinnogl cthoensAiPdIe[reIdCH0GubiedestlairnteinOg1m1a]ter=i>alsM.eetAssttahretidnegfimnaittieorniaolfiInitnecromrepdoiraatteead adesafisniegdniIfnicRaEntAsCtrHucAtrutriacllefr3a(g15m)ent nfo the structure of PIhnatremramcedeiuattiecal inAgctrievdeiepnhtarmaceutical bAmeactoemreiaslapnrAoPdIu.ceIndtdeurrmiendgiastteespsmaofytohremparoycensostibneg iosfolaanteAd.PIItChaHtGuuniddeerlgioneesQ7fu)rther molecular chao pnurifgicateion before it => Meets the definion of Intermediate as defined in REACH Article 315) (Amnedaicctiinvaels)upbrsotdaunccteaonrdAtPhIt,(Awchtievne puhsaerdmaicetuhteipcraolduincgtrieodnieonft)a, dirsugi,ntbenedceodmfeosbaenuascetdivienitnhgeremdaineunftaocfttuhreedoufg dprruogduct Such oSrubpsrteavnencteisonaroofidnitseenadseedofrtfuanfifsehctpthhaermstarcuocltougriecaanldafcutnlctyioonroofthtehre dboidcy.t eIfCfeHctGunidtehleidneiaQgOn)os, ure, mitigation, eaten, => As per Aticl 2(5)a) of REACH -Active substances used in he manufacture medicinal products are exempt fom Authorsation and Registration Medicinal Product Excipient pMreodpiecritineaspfroordturcetataisngdoerfipnreedveinntDiinrgecdiiisveea2se00i1n/hBu3m/EaCn-bAeinnygss;ubosrtAannycesourbsctoamnbcienaotficoonmobfinsautbisotnaonfcessubpsrteasnecnteesdwahsichhavmianyg be. sexeedrtiinnaogr aphdamrimnaicsotleorgeidcatlo,huimmanmbueinngosletoohregrmeiwticatbaohallcviaecwtifon,reostotrionmg,akcionrargemceidonicgralmocdiiafgynoisnsgs.physiological functions by A=c>oAnsstipteureAntocf a2m(e5d)iac)inofeRotEhAerCHtha-nexthcipaicetnitvseussuebdstIanntchee (mNapnsu:fawctwu.reemmead.ceiunraolpapreoudluecntgslaorsesaerxyelemxpctipfioenmt)Authorisation and Registaton Buk product prFoindiuschted medicinal InOtnesrimteedioartteransported AMannyufparcotduurcitnwghiPrcahcthiacsec(oGmpPl)etgeudidaelllipnreosc]essing stages up t, but not including, final packaging [EudraL-Volume 4 - Good VAomleudmieci4na-lGporoodducMtanwuhfiacchtuhraisngunPdraecrtgiocnee(aGllMPst)aggueisdeolfipnreosd]uction, including packaging ns inal container [EudraLex AprsocpeerssAirnglien o3r(1d5e)r, oabneitnrtaernmsefdoiramteedisiatosuabnsottahnecrestuhbasttiasnmcaen(uhfearceitnuarfetdefrorreafnerdecdofnassum"seynitnhoessu')s.edIffotrhechmeamniucfaalcture and Sfuabnseiqnuteenrtmseydnitahessitsorafnaspnoritnedtebretmweedeinanotroesuapnpoltiheedrtsoutbhstearncieest,akfeosr splyancteheosnistnhteosaanmoethseer,sutbisstancaen,oins-sffs ainttreramnesdpioartiee.d I=n>teArrmecdieat2e(.B)b) of REACH- intermediates, as defined in Ace 315), are exempt from Authorisation. Arce 68(1) of [REACH - restrictioinns genaral do not apply to on-site intermediates