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EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol
26.03.2021

EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol

EMA published Revision 3 of the Q&A on the Protocol on Ireland and Northern Ireland on 5 March 2021. The 11-page document contains 28 pairs of questions and answers. It is updated regularly and will be of interest to all GMP professionals who have business relationships with companies in Northern Ireland.

Of particular note in the Q&A document are Q&A 14 "GMP and manufacturing" and Q&A 15 "Parallel distribution":  

  • Manufacturing and import authorizations as well as GMP certificates and GMP non-compliance reports issued for manufacturers in Northern Ireland after the end of the transition period will be made available by the UK authorities in the EudraGMDP database and will be recognized in the EU or EEA.  
  • GMP certificates issued to manufacturers in the rest of the UK and third countries after the end of the transition period will be treated as third country GMP compliance information and will no longer be held in the EudraGDMP database.  
  • GMP inspections are recognized under the EU-UK agreement between the two parties.  
  • There is the possibility of recognition of inspections carried out by UK authorities in third countries. More information on this will follow at a later date.  
  • Notices will remain in place after 31 December 2020 for parallel distributors who have a site in Northern Ireland or who repackage there. However, notices for parallel distributors located at and/or repackaging at other sites in the U.K. will no longer be valid after 31 December 2020. Here, the EMA Guidance on parallel distribution can help.

Source:

EMA: Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland



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