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      Profile Calendar Αρχική About Accessibility Resources EUPATI Fellows FAQ Learning Catalogue Our Impact Patient Engagement Roadmap Patient Expert Training Programme Toolbox About Σύμπτυξη Ανάπτυξη
      About Open Classroom EUPATI Fellows Our Impact FAQ
      Open Classroom Σύμπτυξη Ανάπτυξη
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      Resources Σύμπτυξη Ανάπτυξη
      Glossary EUPATI Toolbox Patient Engagement Roadmap Accessibility Resources
      EUPATI website

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      1. Regulatory procedures - Marketing-Authorisations and their lifecycle management
      2. References legal basis

      References legal basis

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      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
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