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Art. 54a

812.21TPAFederal ActJan 1, 2002Original source
  1. For each medicinal product, a paediatric investigation plan shall be drawn up with a view to its marketing authorisation which sets out the requirements for the development of the medicinal product in paediatrics and which must be submitted to the Agency.
  2. The Federal Council shall regulate:
    1. the procedure;
    2. the requirements for the paediatric investigation plan in accordance with the EU provisions.
  3. It may waive the obligation to prepare a paediatric investigation plan, in particular for medicinal products for the treatment of diseases that occur only in adults. It may provide for a paediatric investigation plan assessed by a foreign authority to be taken into account.

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