News FAMHP

From May 1, 2018 the FAMHP is simplifying a number of procedures for homoeopathic and (traditional) herbal medecines with the intention of streamlining the process and reducing the administrative load for companies and the government.

The European Medicines Agency (EMA) is reviewing the quinolone and fluoroquinolone antibiotics. At its March 2018 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) decided that it would be of benefit to engage the wider EU public in this review.

Brexit has led to a larger number of files relating to changes in Reference Member State (RMS). A new template has accordingly been developed to streamline this process.

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.

In 2017, FAMHP saw a 37% increase in the number of side effects reports received. This remarkable progress is an encouraging sign of ongoing improvements in the safety profiles of medicines; however, FAMHP would still like to encourage all health care professionals to report more side effects.

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.

On March 23, 2018, the royal decree (RD) dated February 23, 2018 was published in the Belgian Legal Gazette that amends two previous decrees: the RD dated June 17, 2013 regarding the packaging, labelling and delivery of magistral and officinal preparations for cough and colds and the decree from the regent dated February 6, 1946 containing the regulation on the storage and sale of toxic substances.

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.

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