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In the case of medicinal products authorised under Directive 2001/83/EC, an application as referred to in Article 8 of this Regulation may be submitted, in accordance with the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC, for authorisation of a new indication, including the extension of an authorisation for use in the paediatric population, a new pharmaceutical form or a new route of administration.
That application shall comply with the requirement laid down in point (a) of Article 7(1).
The procedure shall be limited to the assessment of the specific sections of the summary of product characteristics to be varied.