Document NoM0dYbzRVE8gxkMaGqRe45w

Van: Verzonden: Aan: CC: Onderwerp: (SPF Sante Publique - FOD Volksgezondheid) Reach (SPF Sante Publique - FOD Volksgezondheid) < woensdag, 22 november 2023 11:09 @health.fgov.be> RE: Regulatory challenges faced by medicinal products Dear Thank you for your mail and apologies for my delayed response. Unfortunately we will not be able to organize any more stakeholder meetings this year. However you are kindly invited to send us written information, which we can then share with the Belgian Committee for REACH (BCR). Kind regards, Health Food Chain Safety Environment Chemicals policy advisor =@health.fgov.be Avenue Galilee / Galileelaan, 5 box 2 1210 Bruxelles www.health.belgium.be .be From: @fipra.com> Sent: mardi, 14 novembre 2023 14:31 To: (SPF Sante Publique - F0D Volksgezondheid) < Cc: @fipra.com> Subject: Regulatory challenges faced by medicinal products @health.fgov.be> Dear I am contacting you on behalf of MSD Animal Health, a company developing and producing medicinal products for veterinary uses. We would like to discuss with you the impacts of ongoing regulatory changes in the field of chemicals on the sector. As you know, veterinary medicinal products are currently exempt from REACH authorizations and restrictions. However, certain changes brought by the EU Chemicals Strategy for Sustainability would directly threaten the affordability and accessibility of medicines in the EU as the exemptions do not cover manufacturing and packaging of our products for instance. Packaging, manufacturing as well as imports and exports are being affected in different ways by current regulatory changes in the field of chemicals, including a possible full stop in the use of certain crical substances for products performance and safety as we now can witness also from the current universal PFAS restricon. 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. Given the acve role your country has taken on chemicals, and given the importance to keep medicines supplies available in the EU, would you be available for a call over the next month to discuss these challenges for the veterinary medicinal products sector? We appreciate your kind consideraon and look forward to hearing back from you. Kind regards, Eliot Goarant Consultant M: 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