EMA guidance

EMA guidance

The EMA and HMA have issued a number of documents in relation to Brexit and on the regulatory implications of the UK becoming a third country as of 30 March 2019 for companies and manufacturers.

This guidance includes the requirements for companies to ensure that activities that must be completed in an EU or EEA member state, such as batch release or testing, will be compliant and implemented by 29 March 2019. In order to meet this requirement, there may need to be a change in MAH or RMS in addition to variations or updated manufacturing authorisations.

The EMA guidance is based on the UK becoming a third country with no transitionary period in place. Any changes to this guidance will only become clear once a transition period has been agreed.

The CMDh expects marketing authorisation holders to prepare and proactively screen any authorisations they hold for changes.

All holders of products registered via the centralised procedure should have already received and completed a questionnaire from EMA on Brexit preparedness.

Some of the areas highlighted in the EMA & HMA guidance documents related to location within an EU/EEA member state include:

  • MAH
  • Local Contact Person
  • QPPV
  • ASMF
  • Batch Release Site
  • RMS in MR/DC Procedures
  • Reference products for generic marketing authorisation applications

 

The following Brexit guidance documents can be obtained here:

  • European Commission/EMA questions and answers
  • EMA procedural guidance
  • European Commission/EMA notice to marketing authorisation holders

 

MHRA update to pharmaceutical companies on exit preparations published on 16 January 2018 is available here.

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