Regulation (EC) No 1901/2006 Article 33

Article 33

Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those products have already been marketed with other indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the product on the market taking into account the paediatric indication. A register, coordinated by the Agency, and made publicly available, shall mention these deadlines.

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CitationArticle 33 of Regulation (EC) No 1901/2006 (LawPlayer, data as of 2026-07-04)

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