Life Science


Mrs. Christel Brion

Incentives and Benefits in the Context of Public Healthcare Tenders
15/07/2019

The Federal Agency for Medicinal and Health Products ("FAMHP") recently published a circular (Circular No 646) in which it reminds hospitals that in the context of public procuremen

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Mrs. Christel Brion
Mrs. Florence Verhoestraete

New Measures to Tackle the Unavailability of Medicinal Products
21/05/2019

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

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Acrylamide: zijn frieten ook juridisch schadelijk voor de gezondheid?

Acrylamide: zijn frieten ook juridisch schadelijk voor de gezondheid?
11/04/2019

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.

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EU continues fight against falsified medicines

EU continues fight against falsified medicines
02/04/2019

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.

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Belgium submits draft bill on distributing medicinal cannabis

Belgium submits draft bill on distributing medicinal cannabis
28/03/2019

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.

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Réglementation du secteur alimentaire : la France suspend l’E171

Réglementation du secteur alimentaire : la France suspend l’E171
11/10/2018

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.

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A drug prescription assistance software can be a medical device

A drug prescription assistance software can be a medical device
19/02/2018

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,

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"Whole genome sequencing" coming soon to a clinical practice in Belgium?
12/01/2018

On 19 October, Belgian health Minister Maggie De Block submitted to Parliament her traditional "note de politique générale" on health for the year 2018.

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New Royal Decree organizes the supervision of clinical trials

New Royal Decree organizes the supervision of clinical trials
12/12/2017

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. 

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Mrs. Christel Brion
Mrs. Florence Verhoestraete

Belgian Sunshine Act
26/09/2017

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).

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