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Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally

Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. The FAMHP is now sending these documents in digital format by e-mail. Marketing authorisation holders can still request paper versions.

The FAMHP calls for regularisation of stool banks as establishments of human body material

The FAMHP invites establishments of human body material to apply for regularisation as stool banks. The term "stool" is no longer excluded from the scope of the law of 30 October 2018 on human body material. Establishments carrying out activities on faecal material as described in this law are subject to the implementing Royal Decrees and should apply for regularisation as stool bank.materiaal zoals beschreven in deze wet zijn onderhevig aan de uitvoeringsbesluiten en moeten zich regulariseren als stoelgangbank.

Killapods is considered to be a medicinal product

Based on the risk to the consumer, the Joint Commission’s Chamber for products for human considers Killapods nicotine pouches medicinal product by function.

Coronavirus – Evaluation of the use of saliva samples as an alternative to sampling via a deep nasal swab to detect SARS-CoV-2, the virus that causes COVID-19

Because of the benefits to both patients and healthcare professionals, a study on the use of saliva samples as an alternative to sampling via a deep nasal swab (nasopharyngeal) to detect SARS-CoV-2 using molecular detection tests (PCR) was launched on 28 May 2020.

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.

Illegal skin whitening agents confiscated in Brussels

More than 1 800 illegal skin whitening agents were confiscated in seven shops in a coordinated action in Brussels. The vast majority are skin whitening agents containing corticosteroids which are very popular among the African community. The substances can cause severe side effects such as infections, scarring or adrenal gland insufficiency.

Watch out for identity theft for the illegal obtention of drug precursors

The FAMHP was confronted with a case of identity theft whereby company details where abused for the illegal obtention of drug precursors.

Brexit: European Commission reminds enterprises to be well prepared

Brexit is coming very shortly. And it will have great consequences for many Belgian companies.

Brexit: application of European drug precursors legislation

When the United Kingdom (UK) leaves the European Union (EU) this will have consequences for the trade in drug precursors. Different scenarios are possible.

Survey of external satisfaction

The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.

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