Brexit - EMA publishes questions and answers document on the implementation of the Protocol on Ireland / Northern Ireland for centrally authorised medicines

News Category: Regulatory news

Date: 02/12/2020

This questions and answers document provides additional practical guidance on the applicable rules in Northern Ireland after the transition period with respect to European Medicines Agency (EMA) activities and medicinal products for human and veterinary use within the framework of the centralised procedure.

The information complements the Notice to Stakeholders on the Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medical products and the EMA Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use (within the framework of the centralised procedure).

The Q&A document contains information on:

  • Changes required in the Article 57 database
  • Fees
  • Safety reporting into EudraVigilance and access to EudraVigilance data
  • European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)
  • Electronic Application Forms
  • Periodic safety update report (PSUR) Repository
  • Organisation Management Services
  • Product information
  • Marketing status reporting
  • Dossier submission
  • SME incentives
  • Orphan designation sponsors
  • Good manufacturing practice and manufacturing
  • Parallel distribution

Further information can also be found on the EMA website.

Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a ‘third country’. The Withdrawal Agreement provides for a transition period ending on 31 December 2020. Until that date, EU law in its entirety applies to and in the United Kingdom. As from the end of the transition period, the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) applies.

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