Belgium
New Belgian Royal Decree liberalises the distribution of medical devices
06 March 2019 - Posted by: Kaat Van Delm
On 7 February 2019, the Royal Decree on the liberalisation of the distribution channel of medical devices became applicable (published in the Belgian Official Journal on 28 January 2019). The Royal Decree revokes certain articles in existing Royal Decrees relating to medical devices and two Ministerial Decrees implementing those articles, all of which restricted the › Read More
New Belgian life sciences regulations on pricing and clinical trials published
06 February 2019 - Posted by: Tine Carmeliet
Two new Belgian regulations relevant to life sciences stakeholders were published in the Belgian Official Journal on 31 December 2018. A Ministerial Decree adopted on 21 December 2018 has amended the Ministerial Decree of 17 June 2014, which sets the maximum prices for medical implants, refundable and non-refundable medicines, generic medicines and medicines that are imported › Read More
29 January 2019 - Posted by: Francesca Miotto
Last week, a spokesperson for the Belgian consumer association Test Aankoop/Test Achats announced that the association is likely to lodge a complaint with the Belgian Competition Authority against the Italian pharmaceutical company Leadiant. Allegedly, Leadiant abused its dominant position in the market for chenodeoxycholic acid (CDCA), the active substance in the treatment of the rare › Read More
New Belgian Healthcare Act: Impact on the health sector
21 January 2019 - Posted by: Veerle Pissierssens
The Belgian law of 30 October 2018 concerning several amendments to legislation applicable in the healthcare sector (the Healthcare Act) was published on 16 November 2018. The Healthcare Act introduces the following changes: Introduction of mandatory electronic prescriptions. However, a royal decree has yet to set the date for the introduction of the electronic prescription › Read More
US FDA recognises GMP inspections from Belgian Federal Agency for Medicines and Health Products
24 December 2018 - Posted by: Kaat Van Delm
In November 2018, the FDA recognised the Belgian FAMHP as being capable of carrying out good manufacturing practice (GMP) inspections at a level equivalent to those in the United States. On 1 March 2017, the European Union and the U.S. agreed to amend the Mutual Recognition Agreement from 1998, with regard to the “Sectoral Annex › Read More