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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 14 CELEX: 02006R1901-20190128 1. The Agency shall maintain a list of all waivers. The list shall be regularly updated (at least every year) and made available to the public. 2. The Paediatric Committee may, at any time, adopt an opinion advocating the review of a granted waiver.
In the case of a change affecting a product-specific waiver, the procedure laid down in Article 25 shall apply.
In the case of a change affecting a class waiver, paragraphs 6 and 7 of Article 25 shall apply. 3. If a particular product-specific or class waiver is revoked, the requirement set out in Articles 7 and 8 shall not apply for 36 months from the date of the removal from the list of waivers. |