The European Innovation Network (EU IN) has launched phase 2 of the simultaneous national scientific advice (SNSA) pilot project. SNSA can be used when an applicant wants to obtain national scientific advice from more than one national competent authority (NCA) at the same time. The format is designed to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicines Agencies (HMA), phase 2 of the SNSA pilot project will run for a two-year period until the end of 2024. Phase 2 incorporates an optimised procedure to maximise the benefits for both applicants and competent authorities.
During the end-of-year period, the FAMHP will be closed from Monday 26 December 2022 through Friday 30 December 2022. Deadlines have been set for the submission of different types of dossiers.
PRAC November 2022 – Measures for Janus kinase inhibitors, modified product information of mRNA COVID-19 vaccines Comirnaty and Spikevax, and addition of warning to the product information for ustekinumab (Stelara)
During its November 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. Furthermore, the PRAC recommended to add heavy menstrual bleeding to the product information as a side effect of the mRNA COVID-19 vaccines Comirnaty and Spikevax, and to add a warning to the product information for ustekinumab (Stelara).
The global MedSafetyWeek runs from 7 to 13 November 2022. During this annual social media campaign, the FAMHP is also encouraging everyone to report suspected adverse reactions to medicinal products.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified vaccine Nous-209 for the treatment of colorectal tumors. The public consultation runs from 15 October 2022 to 14 November 2022.
PRAC October 2022 – New measures for terlipressin-containing medicines and change to product information for combination of medicines with codeine and ibuprofen
During its October 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended new measures for terlipressin-containing medicines and has also recommended a change to the product information for codeine with ibuprofen combination medicines. The PRAC also discussed direct healthcare professional communications (DHPCs) containing important safety information for terlipressin-containing medicines and Imbruvica.
The European Commission's new Delegated Regulation (EU) 2022/1518 adds two drug precursors to the list of scheduled substances. The regulation entered into force on 3 October 2022.
Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents
Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.
Ozempic: recommendations for doctors (specialists) and (hospital) pharmacists due to limited availability
There is limited availability of the medicine Ozempic (semaglutide-based solution for subcutaneous injection) due to an acute increase in demand. This limited availability will certainly last until early 2023. Experts from the FAMHP's Unavailability Task Force give recommendations.
The FAMHP wants to warn consumers in Belgium not to use TKTX ointment, an illegal pain-relieving cream. It is mainly used to alleviate pain when applying a tattoo, permanent make-up ... TKTX ointment is not licensed in Belgium or Europe and therefore no guarantees can be given with regard to the composition, safety, quality or efficiency of this illegal medicine.