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Worldwide Regulatory Updates

July 14, 2019

European Union

  • EMVO released a position paper that encourages National Competent Authorities (NCA) to enforce EU FMD standards across the supply chain to prevent stasis during the stabilization period. EMVO suggested that compliance efforts focus on primary issues such as non-connected manufacturers and end-users; end-users that are releasing a serialized product without uploading data; IT providers with inadequate software; and end-users dispensing packs without decommissioning, among other suggestions.
  • EMVO released its Guideline on Divestitures and Acquisitions which encompasses detailed guidelines and templates for managing transfers of marketing authorizations between onboarding partners (OBPs). The process includes changes beyond the PMD level, extending to contracting, legacy alert handling, and potentially product coding.
  • The European Commission released its Aide-Memoire for good manufacturing practice (GMP) inspections which include a checklist of potential questions from inspectors and auditors around EU FMD compliance.

India

  • A public notice has circulated announcing that aggregation and reporting have been postponed until April 1, 2020.
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