During its meeting of April 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines. The PRAC decided to further consider unmet medical need for hydroxyethyl-starch (HES) solutions for infusion and will discuss its recommendation at its May 2018 meeting.

As a result of the changes in the legislation on medical devices, the FAMHP has set up a web portal in order to facilitate registration. The transition period ends on 17th June 2018. From then on, all the operators that fail to register will no longer be able to legally carry out their activities.

The FAMHP publishes a new version of the medicinal product database containing all medicinal products for human and veterinary use authorised in Belgium. You can also find information about the availability or temporary supply problems of medicinal products.

The company Kela Pharma has indicated that, due to production issues, its Maniprex® 250 mg coated tablets and Maniprex® 500 mg film-coated tablets will be unavailable for an indefinite period once current stocks have been exhausted. The stock of Maniprex® 500 mg has already been exhausted, and Kela Pharma predicts, based on normal circumstances, that the stock of Maniprex® 250 mg will be exhausted by June 2018.

At federal level, the authorities concerned, including the FAMHP, are launching a new information campaign on nuclear risk, coordinated by the FPS Interior.

EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta on basis of evidence indicating risk of serious inflammatory brain disorders.

Market authorisation holders for medicines for human use must follow certain labelling and packaging guidelines. These guidelines are being amended.

The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018.

Last updated on 29/06/2017