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References legal basis

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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
7. Types of Marketing Authorisation Applications
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    Lesson 3: Principles and submission of Marketing Authorisation Applications (MAAs) and their types, including the Common Technical Document (CTD)
    References legal basis

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