Belgium

Belgium launches single online portal for health data

Tine Carmeliet

At the initiative of the Minister for Social Affairs and Health Care, on 8 May 2018, the Belgian government announced the launch of a single online portal for health data entitled “MaSanté – MijnGezondheid“. The portal aims to provide citizens with an easily accessible overview of all existing health data (including their personal data) and Read More

Belgian Federal Agency for Medicines and Health Products launches new medicines database

Eveline Van Keymeulen

The Federal Agency for Medicines and Health Products recently launched a new medicinal product database containing information on all medicinal products for human and veterinary use authorised in Belgium. This includes medicinal products that have a valid marketing authorisation, registration, authorisation for parallel import or temporary authorisation for use in Belgium. The database includes a Read More

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