Legislation

Legislative references

Belgian legislation

• Law on medicinal products of 25 March 1964 NL – FR (Article 12bis, §1(11) and (13)),
• Royal Decree of 6 June 1960 NL – FR (subparagraph 13, second sentence)
• Royal Decree of 14 December 2006 (part 1 NL FR - Articles 81 and 82, part 2 NL FR– Articles 208 and 209, Annexes IV and IV ter).

The detailed guidelines of volume 4 of Eudralex were previously only available in English; from now on, they are being progressively published in Dutch en in French, in accordance with the Royal Decree of 14 December 2006.

European legislation

• Directive (EU) 2017/1572
• Directive 2003/94/EC 
• Directive 2001/83/EC (Articles 40, 46, 47)
• Directive 2001/20/EC (Article 13)
• Directive 91/412/EEC for medicinal products for veterinary use
• Regulation 1394/2007 for ATMPs and which refers to Part IV of Volume 4 of Eudralex