Document mmLvMm34mRnq7V3DoJvBrOZjQ

efpXik,a Inandd Associs ations Pharmaceutical Industry -- Identified PFAS Uses mcEs I NY , ms Car MS a) oes >Y EFPIAI Iz We ] Bi =e I Development, Manufacture& SuopfMpedilcinyal Products -- PFAS Use Aimm eeo-- peense eee ySebT aooe oggoe]t ps PEAScontainingmaterials handledin anindustrialset s--I---- -- -- ZtVIe YO i : hos ae FuarinedAPY {activepharmaceutical ingredient) feyromcoonsi ceo) i J Saey be 0) Swearing, . |A = f= rr --_ tty, -- Fs . == 2 `Substitution Impossible (AP! = molecule) `Substitutionchallenges - uniquesubstanceproperties &processvalidation 1 - 3 5 i 7 - etn eont LB [---- =D vv A" " or ------ PFAS Chemicals Used in the Synthesis, Purification or AnalysisofAPIs pr -- + Teheiraspe,utoicwpehpteidfecsleanrcey,a Wun,iqeueocplasosrofoipsharmaceutical agents, intended for a variety of treatments including | F o Aemrineoscasndrttteh ksiengabtlBooouftpcedpkrttidesecstwihoinhta<raeciaosnsetmobelemd oomatrienc. iTWAnis redotsoloef etnhdeopfeIstdeStom | cw, 3 esc reatn EEET,CETT Co = NI -- + (OO QD roviie QED). EE) :0 ror RE La Tolneeate rwesiteerpeaectpioencaokiannisc ficminimaldamageonthepepe Tears sro om ol tra Ifatechnicallyfeasiblealternative Sonne ahars became avai-rlepalabcelmenetof TFA would vcrmaive espe cescinedinth ern og ite sd (Trifluoromethanesulfaocniidc)is also a PFAS -> regrettable substitution PFAS Chemicals Used in the Synthesis, Purification or Analysis of APls LEE TTTa + EDQM produce Pharmacopoeia monographs, which are mandateidn the quality control analysis of medicinal products ado + PEASreagenates used in more than 170pharmcopocia monographs. Of these, 100 prescritbheuseof tflioroacetic acid in the mobile phase of HPLC analytical methods. SE - + More than 50% of 0M reference standards (02500 re preofteercetnict veesltaaynede rartdos)a,vairode socuhpempmlii"ceadlinregealcattsisonvesialbnsewtoiwtehr+ena (1]@ osure components ndcontents + etsiesaurcnhcleanadir.f tdheeveRlesotprmiectnitonaepxpleimepstitoon iQnCLREA(qCuHalfiotry contol laborstory)analysis - rSeuapgpelntyschaanind astkiicnesthies paprooscsuirbielmteyntof FASlaboratory Le -- , i JINiy r]e 5 D oT ne.E 0 a (0 3 he cBoyn =EWsir PZ A a ] k | 7 LZ a -- Te UseofFluoropolymers in production equipment such as reactors, pipework, seals, gaskets and single use systems -- | |fMoParrnpuorfcaoecctseusrsiSasnfegefetaylcayinndedsppraroordduecucdteqpueanlqdiuetaynltiorneraeafsoolnusoropolymer use E oh-- PIgp SERB | oueniicaton of fuorapolymer mates usedis halene: RTF i L AnceGIeSS| EYI || + pirnoecdepsispiinnggan(mdilultiiimteytesrytshtiecmksnwesisl)l,vcaolnvteasi,nskiiglhotmegtlearsssoesfetc. f Eie mes n EE " EE|RR fl | | oorhave compet verve of 1S componentisn complexarticies Lull a Ni er a RON regulatoryapprovalbyglobal healthauthorities i required ay Aflnuyorcoonpdoiltyimoenrsspcloaucleddroensutltheinspurpopdluicetrisoenxipthiansgetohfe market > a,ra supplychain risk is apossibility Hr H n NINN ='\ | hrougthheoenutirte Ifeocfydercoglateed uses vray soem SACHA MER FRYETED MosemoesSons Srereeos ERs Rom sree Human Health Medicinal Products Sector Survey - Impact of PFAS Restriction on Patient Access to Medicines & EU Strategic Autonomy Approximately 1900 active substances impacted by the Restriction because: PFAS used in manufacturing and packaging operations at an EU facility and/or PFAS constituents present in the intermediate packaging or drug delivery device of a medicinal product placed on the EU market Only 7% of the active substances contain the PFAS moiety, and therefore fall under the proposed derogation for APIs Supply chains of 93% of the active substances involve EU manufacturing operations, which depend on fluoropolymers, within plant, equipment and single use systems if these facilities are sole global supplier in a supply chain, medicine shortages are a possibility A wide range of therapeutic areas are impacted e.g. cancer treatment, cardiovascular disease, diabetes, mental health conditions, respiratory disorders. Some products are on critical medicines lists: >600 medicines on WHO Essential Medicines list EU Member State "Critical Medicine" listing e.g. 78% of critical medicines in Norway could be impacted Key Takeaways and quality assurance) owe 3. Partnerships develop across supply chains to: + Develop suitable alternatives that maintain the highly controlled environment required for product efficacy and safety ohio fe