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New guidance documents related to a no-deal scenario

MHRA released six  new guidance documents related to a no-deal scenario —five on importing and exporting medicines and active substances, and one on pediatric studies

Importing and exporting

  1. Importing medicines from an EEA State which is on an approved country for import list
    • List of approved countries for authorised human medicines in a no deal scenario
      • Guidance on importation of investigational medicinal products from approved countries
        • Exporting active substance manufacturer in the UK if we leave the EU without a deal
          • Guidance on air freight of medicines in a no deal scenario

            Medicines for children

            1. Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario

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