Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto.

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• Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto.

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• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
• Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets
• 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)
• Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)Text with EEA relevance



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• Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)
• Treaty establishing the European Community