Document 3evYKn70qyvOB1epErM2xv5o0

rvecs vBerrmouthPeat ofSEAS o--n Pol EACH and ent roduc ios iy 203 po f--Grrnowa..a.InE NRNE S--l H o{erosARR i)ER ve rvei rip ewnesn shephlromwaia cnegchegiaion snd REACH mations of REACH cveronon Aaa EE ------------ re eet fe poe greene ss at steed om Seneca ot eGRdOWon3hstaatnedethlt,ialctohnocuegrh.phhoromaireguhtcmlsdweronrot kellyybobon hre nrrfooresrictions PA inmeptos ott emt ese fo ra perm nToeugShoirmtaA etefcoorsteiA tehefocroimepmlpetcosteeswmalnthtWhtereecponotsacet,orhse cEtoemNpraicntga rier interning srt rast ges te rg ree re th durionof the repmhorsron ovr 1. mEaVof)eocensmiktereury0nvr18 eSernr gereege-- t pate pte lo ition ar nd gede BEEN Erioerara edasemre cooncnnreaeringetheere Coracael pderoeriAngrnoioa ncrch 5 Boi tenE , proces va at tapei dos rors gor Et: individual patient. EFPIAalso expressed the opinion that the options for either the REACH Committee or the MSC to assess essentiaity were inappropriate in the case of pharmaceutical products and insisted for EMA to be involved. In sum, EFPIA took the view that an authorised ``pGhRaOrWm.aFc.e1utrieccaolgpnriosdeudctthawtoCulOdMhawvoeultdo nboetdweaenmtetdotiontfeulrffielrtehweietshsemnetdiiaciatlypcrriotfeersisoino.nals assessments, but that it might not be possible to avoid such discussionsonalternatives. EFPIA offered to contribute with its expertise, for example following the authorisation applications for OPE, in the development of guidance for the revised REACH. GROW F.1 informed that in view of the early stage of the REACH revision, guidance was not currently on the table. However, there was a lear commitment for guidance and this would need lots of discussion. Aso the One Substance One Assessment concept, EFPIA expressed concern regarding ts application for the risk-benefit assessment for pharmaceutical. They expressed some doubts `whether EMA was properly engaged in the ongoing discussions. They urged for the risk-benefit assessmentot take precedence for pharmaceutical products as wel a for the avoidance of delays in pharmaceutical productsreaching the market. `GROW.F.1 welcomed EFPIA' offer to contact EMA inorder tomake them aware of the importance of the One Substance One Assessment discussions, although it was noted that EMA is already involved in Commission's internal meetings on the subject. `Ongoing Commission impact assessment EFPIA confirmed that it was collecting and preparing data on the number of substances that Would fall under the GRA extension in order to support the ongoing Commission impact assessment for the REACH Revision and inquired about the applicable timelines. EFPIA noted that the REACH registration data might not provide the full picture for the pharmaceutical sector, because pharmaceuticals are not subject to REACH registration requirements. GROW.F.1 informed that the impact assessment was scheduled for submission to the Regulatory Scrutiny Board mid-September and would therefore have to be finalised a few weeks before that. Therefore, the timeline to submit any additional data is verytight and data would need to be submitted by the endofAugust a the latest. EFPIA agreed to share what information they can collect from their members within this timeline. The infographics referred to by EFPIA in the meeting are attached.