The unavailability of certain medicines in Belgium is nothing new, and this situation is certainly not unique in Europe. However, with shortages of 428 products reported at the end of April 2019
De risico’s door de aanwezigheid van acrylamide in levensmiddelen noopten de EU tot het nemen van risicobeperkende maatregelen. Exploitanten van levensmiddelenbedrijven van bepaalde levensmiddelen (o.a. frieten, chips, koekjes, …) kregen de verplichting om tal van maatregelen te nemen. De juridische kwalificatie van acrylamide en het regime van deze maatregelen worden in deze blog toegelicht.
Following the European Falsified Medicines Directive, new safety measures entered into force in the EU on 9 February 2019 that guarantee the identification and authenticity of medicinal products and must be adopted by players in the medicinal distribution chain. The European Commission adopted this Regulation that contains detailed rules on safety measures for the packaging of drugs.
On 6 February 2019, a draft bill was submitted to the House of Representatives establishing a government agency for cannabis that would have the exclusive right to distribute medicinal cannabis.
The draft bill proposes that the Federal Agency for Medicines and Health Products (FAMHP) has the authority to organise the cultivation and distribution of cannabis for medicinal use.
L'adoption ce mardi 2 octobre 2018 de la dite loi "Egalim" par l'Assemblée nationale française entraîne la suspension de l’usage du colorant alimentaire E171 dans le secteur alimentaire n’affecte pas que les entreprises françaises mais concerne aussi les entreprises étrangères, dont les entreprises belges, mettant leurs produits sur le marché français. Une entreprise contrevenante s’expose à des sanctions pénales.
In its judgment dated 7 December 2017 (case C-329/16), the Court of Justice of the European Union (CJEU) considered that software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia,
On 19 October, Belgian health Minister Maggie De Block submitted to Parliament her traditional "note de politique générale" on health for the year 2018.
Following the European Regulation on clinical trials on medicinal products for human use, the Belgian legislator adopted a law on 7 May 2017 applying this Regulation in the Belgian legal landscape.
The Sunshine Act [available for consultation here] and its implementing royal decree [available for consultation here] require pharmaceutical and medical devices companies to document and disclose annually on the beTransparent platform [available here] premiums and benefits granted, as from 1 January 2017, directly or indirectly to healthcare professionals (HCPs), healthcare organisations (HCOs) and patient organisations (POs).
On 22 May 2017, the new Belgian law of 7 May 2017 on clinical trials on medicinal products for human use was published in the Official Belgian Journal. This law is in response to Regulation No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use1. The objective of this Regulation is to harmonize clinical trial procedures between EU Member States.
