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The battle against anti-microbial resistance (AMRI) is one of the greatest challenges for our society according to the World Health Organization. Diseases are transferred from humans to animals and vice versa, so actions must be taken for prevention and fighting AMR in both the human and veterinary sector, and even on the level of the environment. This is why the FAMHP, together with all of the authorities involved, are committed to an inter-sector strategy in the battle against AMR, according to the principle of “One World One Health”.

During its meeting of October 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.

During the Christmas holidays, the FAMHP will be closed from Monday 24 December 2018 until Tuesday 1 January 2019 included.

The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XI from 9 to 15 October 2018. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were carried out at the Zaventem and Bierset airports.

Give your opinion on a clinical trial with a genetically modified medicinal product for the treatment of hemophilia B. The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AMT-061 from the company uniQure biopharma B.V. The purpose of this trial is to demonstrate the efficacy of AMT-061 for the treatment of moderate to severe haemophilia B and to further describe its safety aspects. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AVXS-101 from the company AveXis, Inc. The purpose of the trials is to evaluate the safety, tolerability and efficacy of AVXS-101 for the treatment of spinal muscular atrophy. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.

European medicines authorities have placed the Chinese company Zheijiang Huahai under increased supervision and the Indian company Aurobindo Pharma is no longer allowed to supply irbesartan to EU member states.

The European Medicines Agency (EMA) published the eighth ESVAC (European Surveillance of Veterinary Antimicrobial Consumption) report on the sale of antibacterials for veterinary use in 2016.

Until today, the good manufacturing practices (GMP) for medicinal products were only available in English. As of now, the GMP will be available in French and Dutch on the FAMHP website.

The FAMHP would like to remind consumers and patients about a recall by Reckitt Benckiser of Durex Natural Feeling Extra Lubricated condoms and Durex Real Feeling latex-free polyisoprene condoms. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.