Belgium

Belgian report shows limited success in screening of health insurance funds

Veerle Pissierssens

A recent report from the Belgian Court of Audit reportedly shows that the information that health insurance funds must disclose pursuant to the requirements set in the 2016 “Future Pact” (Toekomstpact), which mainly pertain to internal inspections and accountancy, is too fragmented and therefore of little use. The report also recommends granting inspection services access to Read More

New directive on GMP transposed into Belgian law

Tine Carmeliet

On 20 July 2018, the Royal Decree of 27 June 2018, which implements Commission Directive 2017/1572 as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (GMP Directive), was published. The decree should have been implemented on 31 March 2018, when the GMP Directive entered into force. While the Read More

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