Belgium
Belgium launches single online portal for health data
05 June 2018 - Posted by: 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
16 May 2018 - Posted by: 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
09 April 2018 - Posted by: 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
23 March 2018 - Posted by: 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
06 March 2018 - Posted by: 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