Belgium

Belgian regulator amends guidelines on labelling and packaging of human medicines

Tine Carmeliet

On 1 March 2018, the Federal Agency for Medicines and Health Products (FAMHP) published amended guidelines on the labelling of medicines within the context of new marketing authorisations, renewals or variations for medicines for human use.  Pharmaceutical companies should comply with these guidelines, which stipulate specific requirements for the packaging and labelling of medicines. The Read More

Belgium adopts new Royal Decree on biobanks

Veerle Pissierssens

The new Royal Decree on biobanks was published on 5 February 2018 in the Belgian Official Gazette.  A biobank stores human tissue and makes it available for scientific research only (that is, not for human use).  The decree, which implements the Law of 19 December 2008 in relation to obtaining and using human tissue in Read More

Belgium to strengthen role of e-health apps in patient healthcare

Veerle Pissierssens

The Belgian Minister of Health has announced in a press release that she is seeking to integrate mobile medical applications (e-health apps) into the Belgian healthcare system. In order to ensure the quality of such e-health apps and the safety of patients, these apps will be evaluated under a specific scheme (Evaluation Scheme) and some Read More

Belgium: Digital platform for medical files to be launched

Tine Carmeliet

In early January 2018, the Belgian Minister of Health published an announcement on the creation of a digital platform called the “Personal Health Viewer”. The goal of this digitalisation initiative is to engage patients in the management of their own health. In particular, the platform will enable patients to access their own medical file online and Read More

Belgium: New proposal to cease reimbursement of costly medicinal products after patent expiry

Tine Carmeliet

In December 2017, the Commission of Social Affairs of the Belgian Chamber of Representatives approved the Minister of Health’s proposal to cease the reimbursement of certain medicinal products which after patent expiry remain much more expensive than less costly alternatives. The proposal, which has not been published, must be formally approved by the Chamber of Read More