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  • Notice to stakeholders on the withdrawal of the United Kingdom and EU rules for national authorised medicinal products for human use (February 2019) [Track version]

  • Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human use (February 2019) [Track version]
  • Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (February 2019)[Track version]
  • Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products (February 2019)

  • Template for Notification of request for a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product (February 2019)
  • Contact points for requests for exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product (February 2019)

  • National information on MAH transfers (January 2019)
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