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The Federal Agency for Medicines and Health Products (FAMHP) is looking for doctors and pharmacists responsible for education who want to become members of the Oversight Committee on the advertising for medicines.

During its meeting of May 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for Xeljanz (tofacitinib). PRAC has issued restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs.

The FAMHP notifies marketing authorization holders (MA) of drugs for human use of the necessity of each change made to a file (= modules 1 through 5) being linked to an MA must be the subject of a corresponding variation or notification request.

Not all fees for drug packaging are subject to VAT. The Federal Agency for Medicines and Health Products (FAMHP) clarifies when VAT is applicable and when it is not.

On 20 May 2019, the law changing provisions regarding providing scientific and technical advice by the Federal Agency for Medicines and Health Products and regarding the financing of the Federal Agency for Medicines and Health Products (financing law of 2019) has been published in the Belgian Official Gazette. The new law changes a number of aspects of the function and financing of the Federal Agency for Medicines and Health Products (FAMHP).

The FAMHP has decided to no longer handle files on parallel import in the separate Parallel Import Entity of the Marketing Authorisation Division (variations and renewals). This decision was made to guarantee the analogy with reference drugs and to better follow up on procedures.

The Federal Agency for Medicines and Health Products (FAMHP) will send out invoices for most of its services from now on. Consequently, companies will no longer need to make advance payments when submitting files.

The FAMHP is working closely with the affected parties to find a solution for clinical trials which may encounter problems after Brexit.

The FAMHP points out to marketing authorisation (MA) holders and applicants the rules for harmonisation of SPC’s, labelling and patient information leaflets (PIL) in different countries. MA holders and applicants can find all new rules on the FAMHP website.

A new law states that full line wholesalers can only provision the Belgian marker, in the framework of their public service services. Medicines intended for the Belgian market can only be supplied to Belgian pharmacies or other wholesaler-distributors. Implementation decrees will supplement the law. For example, medicines that cannot be delivered for three days in a row are considered unavailable. The obligation to deliver from pharmaceutical companies to full line wholesalers will also be set on three working days.