• Inicio
  • Formações
  • Formação à Medida
  • News & Trends
  • Sobre nós
  • Contacto

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

              News & Trends

              Procurar

              Recentes

              • A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
              • Electronic Submission Template for Premarket Approval Applications (PMAs)
              • MDSAP Technical Review and Recognition Decision Procedure
              • Essential Principles and Content of Predetermined Change Control Plans. Final Document
              • Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024
              • GMP and GDP Question and Answer Guide Version 03 published by ECA
              • Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 2)
              • Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies

              91 257 00 03 (Chamada para a rede móvel nacional)
              info@formiventos.com

              • Follow
              • CLIENTES & TESTIMONIALS
              • ASSOCIAÇÕES OFICIAIS
              • CERTIFICAÇÕES E CREDITAÇÕES
              • ADVISORY BOARD
              • Política de Privacidade
              • Contacto