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    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

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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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