As of March 30, 2019, the United Kingdom will become a “third country.” Applicants and marketing authorization holders (MAHs) of centrally authorized medicinal products for human and veterinary use should consider how Brexit will impact their medicines and make the necessary changes in a timely manner before that date. The European Medicines Agency (EMA) recently published Additional Guidance for procedures related to Brexit for medicinal products for these centrally authorized products. The Additional Guidance provides clarifications on practical and procedural requirements regarding the submission of changes to marketing authorizations and related fees that MAHs should follow. The Additional Guidance also addresses the transfer of orphan designations.
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