News FAMHP

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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 and New safety information for healthcare professionals for Zolgensma

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.

Important for clinical trials sponsors: mandatory use of E-Submission Food Chain platform for clinical trials with genetically modified medicinal products

Since 1 October 2022, all Summary Notification Information Format documents submitted with applications for clinical trials with medicinal products, entirely or partly composed of genetically modified organisms covered by Directive 2001/18/EC for deliberate release, must be submitted through the E-Submission Food Chain platform.

Point of contact at authorisation holders for the supply and availability of medicinal products

The FAMHP reminds marketing authorisation holders for medicinal products for human use to register a single point of contact (i-SPOC) for the supply and availability of medicinal products through the IRIS platform of the EMA.

New Clinical Trial Regulation: new transition phase, possible delays in the processing of substantial modifications, and information sessions for sponsors

The new Clinical Trial Regulation 536/2014 (CTR) entered into force on 31 January 2022. This new regulation on clinical trials applications of medicines for human use aims to simplify administration and harmonise legislation within the European Union. On 31 January 2023, a new transition phase will start and from then on all initial clinical trial applications have to be submitted via CTIS. The FAMHP is organising two information sessions on the clinical trials regulation.

FAMHP reminds of need for customer declaration for buyers of category 1 or 2 chemicals

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).

New antimicrobial medicine available in Belgium: Arikayce liposomal

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.

PRAC December 2022 – Recommendation of withdrawal of pholcodine medicines from European market

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.

Flash VIG-news: Pregabalin (Lyrica and generics): risks of misuse, abuse, and dependence

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.

Simultaneous national scientific advice pilot project: launch of phase 2

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.

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