Legislation

Legislative references

Belgian legislation

  • Law on medicinal products of 25 March 1964 NLFR (Article 12bis, §1(11) and (13)),
  • Royal Decree of 6 June 1960 NLFR (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

 

Last updated on 29/10/2018