News FAMHP

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Coronavirus: the FAMHP continues to supply essential medicinal products for intensive care and provides hospitals with daily updates

The FAMHP is addressing the concerns of healthcare professionals. To cope with the difficulties in supplying medicinal products, FAMHP experts are in constant contact with hospital pharmacies and are working tirelessly to find solutions. There is currently no shortage of medicinal products preventing the treatment of COVID-19 patients in Belgium.

COVID-19: electronic files submission

Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.

Coronavirus: no shortage in medication supply, FAMHP closely monitoring the situation

Following the coronavirus epidemic (COVID-19), experts at FAMHP are actively monitoring the potential impact on the availability of medication and medical devices in Belgium. The FAMHP is also supporting the European Medicines Agency (EMA) in developing COVID-19 vaccines.

PharmaStatus: a new online application on the availability of medicines

The FAMHP launches PharmaStatus, the new online application that collects information about the availability of medicines in Belgium and makes it public. Current information will help patients, doctors, pharmacists and the pharmaceutical industry to limit the impact of unavailable medicines.

The fight against anti-microbial resistance continues: the Belgian BAPCOC 2019 antibiotics guide is available on the CBIP website

As recommended by the Belgian Health Care Knowledge Centre (KCE), a new step in the fight against anti-microbial resistance has been taken: the 2019 edition of the Belgian Antibiotic Policy Coordination Committee (BAPCOC)’s antibiotics guide is available online on the Belgian Pharmacotherapy Information Centre (CBIP) website.

Holders of marketing authorizations must check their data in the EMA’s article 57 database

The Vigilance Division of the FAMHP has found encoding errors in the article 57 database of the EMA. The FAMHP is asking holders of a marketing authorization for a medicine to carefully check that their registered data are correct.

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.

Good manufacturing practices for medicinal products available in French and Dutch

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.

CESP: updated privacy notice for GDPR

CESP (Common European Submission Portal), the European online system to exchange information between applicants of authorisations and competent authorities will have an update on 29 June 2018 to conform to the new General Data Protection Regulation (GDPR).

Information sessions on auto control of the sector of medical devices - 8th September and 2nd October 2017

The Directorate-General INSPECTION of the FAMHP organises two information sessions on Friday 8th September and Monday 2nd October 2017 in the Storck room, SPF Emploi, 1 rue Ernest Blerotstraat, 1070 BRUSSELS.

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