Document 70yg16Y4R2BQzgJpyOpbgrJjg

(SPF Sant Publique - FOD Volksgezondheid) From: (SPF Sant Publique - FOD Volksgezondheid) Sent: To: Cc: Subject: Attachments: lundi, 23 octobre 2023 11:48 (SPF Sant Publique - FOD Volksgezondheid) (SPF Sant Publique - FOD Volksgezondheid) TR: PFAS restriction & medicinal products efpia-ahe-pfas_position_june-2023-final.pdf; efpia-report-in-response-the-annex-xvpfas-restriction-proposal.pdf Dag , FYI , Ik denk dat FIPRA was uitgenodigd aan onze BCR open sessie EUPFAS . Als ja > ik zou liever weigeren Groetjes, De : (SPF Sant Publique - FOD Volksgezondheid) < Envoy : lundi, 23 octobre 2023 11:45 : (SPF Sant Publique - FOD Volksgezondheid) < Objet : TR: PFAS restriction & medicinal products A toi de voir ... @health.fgov.be> @health.fgov.be> D @fipra.com> Envoy : lundi, 23 octobre 2023 10:58 : (SPF Sant Publique - FOD Volksgezondheid) < Objet : PFAS restriction & medicinal products @health.fgov.be> Dear , I am contacting you on behalf of MSD Animal Health, a global company developing and producing medicinal products for veterinary uses. We would like to exchange with you on the impacts the universal PFAS restriction proposal might have on the animal health sector; proposal which is currently being discussed in ECHA's RAC and SEAC committees. This REACH Restriction aims to ban the manufacture, use and placing on the market of at least 10,000 PFAS, and is the most complex restriction ever proposed in the EU. Such a broad ban might entail significant impact and unintended consequences across various industries, including the pharmaceutical sector. Medicinal products are supervised by the European Medicines Agency, subject to very strict sectoral regulations, complex authorization procedures as well as long R&D cycles and costly clinical trials. This makes substitution far more challenging than for almost any other product. Due to various industry activities and particularly to our sectoral regulations, the risks both in terms of health and environment are sufficiently under control and we are constantly looking at ways to improve. This will include also measures to better monitor and report use and emission of PFAS as well as ways to speed substitution. Given the active role your country has taken on this important issue, and given the urgency of the matter, would you be available for a call over the next month to discuss the challenges of the PFAS restriction proposal for the veterinary medicinal products sector, in view of upcoming RAC/SEAC meetings? 1 We appreciate your kind consideration and look forward to hearing back from you. Please find attached the position of our sector for information. Kind regards, Consultant A: Rue de la Loi 227, Brussels 1040, Belgium FIPRA fipra.com | Twitter | LinkedIn This transmission is confidential. If received in error please notify the sender and delete. FIPRA Network: public affairs in over 50 countries 2