CRED Successful and Skilful Communications 2025

Recap: Who are the external “regulators/ gate-keepers”?

• The European Medicines Agency • The Biocidal Products Committee/ European Chemicals Agency • National Competent Authorities (e.g. AIFA, BfArM, DIKLZ, FAMHP, FDA, HPRA, MHRA, URPLWMiPB) • Notified Bodies (e.g. BSI, LRQA, NSAI, SGS Belgium, TÜV NORD) • Trade Associations: ● Biocides: EFTA, ● Cosmetics: Cosmetics Europe, CTPA ● Medicines: EFPIA, EuropaBio, Animal Health Europe, Pharma.be, BAH ● Medical Devices, ABHI, BIVDA, BVMed, EMIG, Eucomed, MedTech Europe

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Some gatekeepers suggested by you

• Regional team – supporting a local issue or product roll-out • Local affiliate – regional team may need to negotiate and brief on meeting with a national authority • Local exporter/ importer • Authorised representative (for medical devices) • Research Ethics Committee • Health Technology Assessment Institute • Other company – divestment, due diligence, licence acquisition • Quality Assurance • External manufacturer

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