Distributors and vendors of category 1 or 2 chemicals must require the buyer to provide a customer declaration of specific use. This is legally required by Regulation (EC) No 273/2004 and aims to protect trade in drug precursors (substances that can be used to make drugs).
The availability of appropriate antimicrobial medicines gives doctors more options to provide the best treatment to their patients. Its availability is also important in the fight against antimicrobial resistance. Arikayce is an antimicrobial that was recently marketed in Belgium.
During its December 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has concluded its review of medicines containing pholcodine and has recommended the revocation of the European marketing authorisations for these medicines.
For several years, health authorities in European countries have noted a worrying increase in pregabalin abuse. Here are some reminders of the risks of misuse, abuse, and addiction with pregabalin.
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.