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10-Jul-2020 21:18

Good progress had also been made for products with QPPVs and pharmacovigilance system master files (PSMFs) based in the UK.Although companies have reassured EMA that their plans are in place, the Agency reminds them of their responsibility to make the necessary changes required by EU law as soon as possible.For more information, see: They should submit a scanned and signed copy as well as an editable version of the request to EMA via email or Eudralink to [email protected](copying the Product Lead and the product mailbox for human medicines and [email protected] veterinary medicines) as soon as possible and no later than by the date of Brexit.EMA will notify individual marketing authorisation holders whether their request has been granted as quickly as possible.For procedural or regulatory queries related to type I variations for human medicines, contact [email protected] [email protected] human and veterinary initial marketing authorisation applications, EMA holds all pre-submission meetings requested as of 1 October 2018 remotely, either via teleconference or virtual meeting.EMA continues to urge pharmaceutical companies to make the changes required by EU law to enable them to continue to market a medicine in the EU after Brexit.

For more information and guidance, see: Marketing authorisation holders should email [email protected](copying the Product Lead and the product mailbox) if their plans change for submitting Brexit-related post-authorisation applications.(19 human medicines and 12 veterinary medicines) for which it remained concerned about potential Brexit-related supply disruptions.



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