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Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) article 32 CELEX: 02006R1901-20190128 1. Where a medicinal product is granted a marketing authorisation for a paediatric indication, the label shall display the symbol agreed in accordance with paragraph 2. The package leaflet shall contain an explanation of the meaning of the symbol. 2. By 26 January 2008, the Commission shall select a symbol following a recommendation of the Paediatric Committee. The Commission shall make the symbol public. 3. The provisions of this Article shall also apply to medicinal products authorised before the entry into force of this Regulation, and to medicinal products authorised after the entry into force of this Regulation but before the symbol has been made public, if they are authorised for paediatric indications.
In this case, the symbol and the explanation referred to in paragraph 1 shall be included in the labelling and package leaflet respectively of the medicinal products concerned not later than two years after the symbol has been made public. |