Belgium

New Belgian life sciences regulations on pricing and clinical trials published

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

Belgian consumer association announces potential complaint for abuse of dominance based on excessive pricing allegations

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

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

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

Belgium: Mobile health apps can now be published on mhealthbelgium.be

Kaat Van Delm

From the end of October 2018 onwards, companies can apply for publication of their mobile health-applications (mhealth apps) on the governmental website “mhealthbelgium.be“. The website aims to encourage mobile health and make mhealth patient care an integrated pillar of the healthcare sector. It has been created through cooperation among Belgian authorities for food, medicines and Read More