Ir para o conteúdo principal
Se continuar a navegar neste site, concorda com as nossas políticas:
  • Terms and Conditions
  • Privacy & Cookies Policy
Continuar
x
    • Página principal
    • About
      About Open Classroom EUPATI Fellows Our Impact FAQ
    • Open Classroom
      Patient Expert Training Programme Learning Catalogue
    • Resources
      Glossary EUPATI Toolbox Patient Engagement Roadmap Accessibility Resources
    • EUPATI website
    • Mais
    Português - Portugal ‎(pt)‎
    English ‎(en_wp)‎ Português - Portugal ‎(pt)‎ Ελληνικά ‎(el_wp)‎
    A aceder como visitante
    Entrar

      Side Drawer

      EUPATI Open Classroom
      Course home
      Profile Calendar Página principal About Contrair Expandir
      About Open Classroom EUPATI Fellows Our Impact FAQ
      Open Classroom Contrair Expandir
      Patient Expert Training Programme Learning Catalogue
      Resources Contrair Expandir
      Glossary EUPATI Toolbox Patient Engagement Roadmap Accessibility Resources
      EUPATI website

      Side Drawer

      Expandir tudo Contrair tudo
      Course home
      1. Regulatory procedures - Marketing-Authorisations and their lifecycle management
      2. Lesson 3: Principles and submission of Marketing Authorisation Applications (MAAs) and their types, including the Common Technical Document (CTD)
      3. References legal basis

      References legal basis

      Requisitos de conclusão
      Visualizar

      References

      1. Regulation (EC) No 726/2004
      2. Directive 2001/83/EC, as amended
      3. Annex I in Directive 2001/83/EC, as amended
      4. The Rules governing Medicinal Products in the European Union, Notice to Applicants, Volume 2A, Chapter 1
      5. CHMP guideline on similar biological medicinal products
      Previous Activity
      Next Activity

      Footer

      A aceder como visitante (Entrar)
      Políticas
      Obter a Aplicação móvel
      Fornecido por Moodle

      The EUPATI Open Classroom was initially launched with support from the EUPATI Reload project, funded by EIT Health. EIT Health is supported by EIT, a body of the European Union. 

      For more information about EUPATI, please access our website www.eupati.eu or contact us at openclassroom@eupati.eu

      EIT Health logo and EU logo

      Terms and Conditions

      Privacy and Cookie Policy

      © 2024 EUPATI

      Select banner image