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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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