2.
The application shall be accompanied by the following: a reference to the original application; a technical dossier containing the new information in accordance with the guidelines referred to in Article 9(2); a new complete summary of the technical dossier in a standardised form.
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Source: EUR-Lex (Cellar) · retrieved 2026-10-30 · Text as adopted (Official Journal); later amendments are not incorporated in this text.