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Flash VIG-news : Marketing stop of Depakine (sodium valproate) 300 mg/5 ml syrup - beware of medication errors

Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 28 2025. However, Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As this drink is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.

Applications for revisions to the register of pharmacies can from now on be done online

In Belgium, any authorisation for the opening, merger, transfer, temporary and permanent closure of a pharmacy open to the public must be registered in the FAMHP's register of pharmacies. In addition, any change, such as a different pharmacist in charge, an additional cadastral plot or the acquisition of a pharmacy, must be reported to the FAMHP. From now on, the FAMHP's new online application can be used for this purpose.

Publication of a guidance for the implementation of a self-checking system related to the installation and maintenance of medical devices used in the diagnosis and treatment of sleep apnea syndrome outside the hospital

Pursuant to the Royal Decree of 24 October 2024, the FAMHP has approved a guide explaining in detail all the aspects that actors in the service and technical home assistance (STHA) sector must take into account to correctly set up a self-checking system. This guide includes a set of obligations.

Notification procedure for advertising of medicinal products for veterinary use to the public

On 1 January 2025, the Royal Decree of 22 September 2024 on advertising of medicinal products for veterinary use will come into force. That Decree describes the mandatory notification procedure prior to the distribution of any advertisement for a medicinal product for veterinary use to the general public.

Register for the Seventh Vigilance Day

On 12th December 2024, the Vigilance Division of the FAMHP will organise the seventh edition of Vigilance Day. This year, we are opting for a webinar.

Significant increase in the number of Belgians who have registered their will to make a donation of human body material in 2023

The Orgadon annual report provides quantitative data on the donation of human body material in Belgium since 2020. In 2023, the number of declarations of explicit consent increased considerably, while the number of declarations of opposition showed a slight increase.

Limited availability of intravenous infusion fluids: recommendations for physicians (specialists) and (hospital) pharmacists

The Federal Agency for Medicines and Health Products (FAMHP) was notified on 15 October 2024, by the company Baxter of the limited availability of certain infusion fluids for intravenous (IV) administration until 31 December 2024. Indeed, Baxter's largest manufacturing facility in North Cove (North Carolina, United States of America) was severely affected by Hurricane Helene.

Important call to clinical trial sponsors: transfer clinical trials to the CTR as soon as possible

From 31 January 2025, only the Clinical Trials Regulation (EU) 536/2014 and its delegated acts will apply, as stipulated in Article 98 of the regulation. The FAMHP calls on sponsors to transfer clinical trials to Regulation 536/2014 as soon as possible.

Deadlines for the submission of dossiers during the end-of-year period

During the end-of-year period, the FAMHP will be closed from Wednesday 25 December 2024 to Wednesday 1 January 2025. Deadlines have been set for the submission of different types of dossiers.

The FAMHP once again takes part in the global campaign for safer use of medicines

Today sees the start of the ninth edition of #MedSafetyWeek, a global campaign running from 4 to 10 November 2024, bringing together 107 organisations from 94 countries. This year's theme is the importance of using medicines correctly in order to prevent adverse effects and to report them if they occur.

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