Guidance is Relevant to DCP/MRP/National Marketing Authorisations

CMDh has issued an updated Questions and Answers document regarding Brexit for how Marketing Authorisation activities will proceed in the event of no withdrawal agreement and hence without a transition period. 
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_361_2017_Rev3_01_2019_clean_-_QA_on_BREXIT.pdf

Key points in the document and new updates are:

  • If the UK is RMS at time of Brexit a MAA procedure will terminate and the applicant will need to resubmit with a new RMS. If the product is deemed a critical product, a CMS may become the RMS and complete the procedure.
  • If the UK is RMS at time of Brexit ongoing variations and renewal procedures will be terminated.
  • Falsified Medicinal product Directive (FMD) and unique identifiers.  The UK will become a 3rd country and will not have access to the Union hub for uploading the unique identifiers.
  • Parallel trade of medicines sourced in the UK will no longer be allowed post-Brexit however products sourced and brought into the EEA prior to Brexit can continue to circulate.
  • PV and ICSRs. Suspected non-serious adverse reactions occurring after Brexit in the UK do not have to be reported to EudraVigilance. MHRA will no longer have access to EudraVigilance.
  • PSURs. Post Brexit, for the calculation of exposure UK patient exposure should be considered as part of the non-EU/EEA regions.

Feedback at the Euro DIA meeting was that:

  • 49% of products where the UK was the RMS have switched to a new RMS
  • 25% of products have the switch agreed in principle but pending completion of other procedures
  • 26% of RMS switch are still due which is of concern to CMDh.
  • New RMS distribution is still not equal but more countries are involved: DE (n=486), IE (n=397), NL (n=219), DK (n=112), IT (n=111), SE (n=102), AT (n=98) …
  • Batch release in the UK.  Trade association considers it could be legally allowed for the UK to continue to release batches which states ‘where arrangements are in place’. Previously this was met via a Mutual Recognition Agreement (MRA) however this is not a legal requirement.