My bookmarksSign up free

Regulation (EC) No 1901/2006 CHAPTER 3 — Identification

Article 32 · 1 article

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 32

Open ↗

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.

Back to Regulation (EC) No 1901/2006 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next