Mdeon is approved to ensure, in self-regulation, the prior visa procedure as stated in article 10, §3 of the Law on Medicinal products.
Mdeon was first approved by the Royal Decree of February 25, 2007 with retroactive effect on January 1st, 2007, date on which the visa procedure came into force.
In the light of its annual activity report and of an annual independent external audit, Mdeon’s approval was renewed by the King year after year:
- for the first time on April 11, 2008, by Royal Decree of March 11, 2008
- for the second time on April 10, 2009 by Royal Decree of March 30, 2009
- for the third time on April 21, 2010 by Royal Decree of April 6, 2010
- for the fourth time on April 6, 2011 by Royal Decree of March 22, 2011
- for the fifth time on April 16, 2012 by Royal Decree of March 29, 2012
- for the sixth time on April 19, 2013 by Royal Decree of April 3, 2013
- for the seventh time on May 8, 2014, by Royal Decree of April 10, 2014
- for the eighth time on May 8, 2015, by Royal Decree of 3 April 2015
- for the ninth time on April 28th, by Royal Decree of April 19th 2017
- for the tenth time on July 6th, by Royal Decree of June 6th 2018
- for the eleventh time on May 19th, by Royal Decree of May 6th 2021.
The current approval is valid until 31 May 2024.