News - page 2 - Healixia

February 22, 2023

Healixia award 2023: nominations

The Healixia Award is a new yearly tradition that was introduced in 2022. As a community of professionals, it is important to keep up with what is happening within our sector, in all the different domains we represent. Via this award, we want to honor a professional who made or makes a major contribution to our life science eco-system in Belgium and the mission of our organization.

February 22, 2023

Mandatory application for export in the event of unavailability of essential medicines

De federale regering heeft een koninklijk besluit genomen waardoor de uitvoer van geneesmiddelen tijdelijk kan worden beperkt. Het besluit laat toe een de export in geval van onbeschikbaarheid te onderwerpen aan een voorafgaandelijke toelating, als het over essentiële geneesmiddelen gaat en aan bepaalde voorwaarden is voldaan.

Le gouvernement fédéral a pris un arrêté royal autorisant une restriction temporaire à l'exportation de médicaments. L'arrêté permet de soumettre les exportations en cas d'indisponibilité, lorsqu'il s'agit de médicaments essentiels et si certaines conditions sont remplies, à une autorisation préalable.

Source: FAMHP

February 22, 2023

Five new drug precursors added to list of scheduled substances

The European Commission's new Delegated Regulation (EU) 2023/196 adds five drug precursors to the list of scheduled substances. These are substances that can be used to produce fentanyl or amphetamines. The trade, possession and use of these substances are subject to governmental supervision. The regulation enters into force on 20 February 2023.

Source: FAMHP

February 14, 2023

IFAPP Today newsletter - February 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of February 2023.

January 27, 2023

End of the validation procedure for SARS-CoV-2 antigen self-tests

The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.

Source: FAMHP

January 27, 2023

PRAC January 2023 - recommendations for Janus kinase (JAK) inhibitors and information about Zolgensma

Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
EMA’s safety committee (PRAC) has further reviewed measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Source: FAMHP

January 17, 2023

IFAPP Today newsletter - January 2023

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of January 2023.

January 12, 2023

COVID-19: Audit Hospitals re-estimates hospital care not provided

Deze audit onderzoekt de niet-uitgevoerde ziekenhuiszorg en gecumuleerde potentiële zorgachterstanden vanaf het begin van de pandemie tot en met de zesde golf (van mei 2021 tot en met mei 2022).

L’audit porte sur les soins non effectués et les retards accumulés dans les hôpitaux depuis le début de la pandémie jusqu’à la sixième vague incluse (de mai 2021 à mai 2022).

Source: FAMHP

January 10, 2023

IFAPP virtual training workshop: Introduction to the new EU Clinical Trial Regulation

From 31 January 2023 all clinical trials with medicines must be authorised, handled and reported according to the rules lined out in the Regulation EU No 536/2014 (Clinical Trials Regulation).

January 10, 2023

Indexation of hospitality amounts, fees to apply for Mdeon visum and sponsoring virtual and hybrid meetings.

As from January 1st, 2023, a number of novelties will take effect regarding the amounts for hospitality, the amounts of the fees to apply for an Mdeon visum and the sponsoring of virtual and hybrid meetings.