Based on this template requests should be submitted as early as possible, but no later than on March 29, 2019 via e-mail or Eudralink (email@example.com).
If the exemption is granted, the MAH must provide a copy of such exemption to the EU27/EEA competent authority that granted the manufacturing authorisation for the batch release site and to the qualified person of the batch release site. Based on the exemption and batch control testing results from the site located in the UK, the qualified person can release batches specified in the exemption for placing on the Union market.
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