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Symposium on working with and for the patient

The patient is one of the most important partners for the Federal Agency for Medicines and Health Products (FAMHP). In response to this, two symposia have already been organized regarding working with and for the patient.

Use of the OTC QRD template for medicines delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946

As of 1 January 2019, the holders of a marketing authorisation (MA) must use the OTC version of the QRD template for drugs delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946.

Safety report for ophthalmologists and patients for the ocular implant Raindrop Near Vision Inlay from the manufacturer Revision Optics

The FAMHP wants to notify ophthalmologists and patients of a safety report from the American government, the Food and Drug Administration (FDA) on the ocular implant Raindrop Near Vision Inlay from the manufacturer Revision Optics. At this time there is no information that the ocular implant was also distributed in Belgium.

Recognition of the FAMHP by the American Food and Drug Administration (FDA)

The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.

Give your opinion on a genetically modified vaccine against respiratory syncytial virus (RSV) infections

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified ChAd155-RSV vaccine from the company GlaxoSmithKline Biologicals. The purpose of this trial is to provide critical information on the safety, reactogenicity and immunogenicity profile of the ChAd155-RSV vaccine in infants, as well as on the risk of vaccine-induced enhanced RSV disease after vaccination. The public consultation runs from 26 November 2018 to 26 December 2018 inclusive.

Make medicines safer by reporting side effects in children or during pregnancy or breast feeding. The FAMHP again participates in an international campaign to emphasize the importance of reporting side effects.

The campaign will run from the 19th to the 23rd of November and is part of an awareness week of 32 drug authorities from the EU, South America, the Middle East and Australia.

Update on the new Clinical Trial Regulation pilot project

The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium.

Publication of the update of the Guidance for submission of CTA initial dossiers, substantial amendments and end of trial notifications to the FAMHP

Submission of dossiers and documents to the Research and Development Division (human use) of the FAMHP via the CESP is compulsory since 1 October 2018. Today, the FAMHP publishes version 1.2 of the guidance.

Antibiotic Awareness Week: working together to reduce anti-microbial resistance.

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”.

PRAC October 2018 – Recommendation to restrict the use of fluoroquinolone and quinolone antibiotics

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.

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