The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.
Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication
Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.
Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.
The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.
PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines
During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.
Based on the risk to the consumer, the Joint Commission’s Chamber for products for human considers Killapods nicotine pouches medicinal product by function.
Nitrosamines in medicinal products: deadlines for submitting risk assessments, the results of confirmatory tests and the MA adaptation
Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments must be reported via the particular web form, before 31 March 2021 for chemical medicinal products and before 1 July 2021 for biological medicinal products. MA (marketing authorisation) variations must be submitted before 26 September 2022 (chemical medicinal products) and before 1 July 2023 (biological medicinal products).
Coronavirus and the fight led by the FAMHP: the FAMHP carries out hundreds of controls and inspections to ensure the compliance and safety of medicines and health products
Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly and have devoted a lot of resources to monitoring medical devices delivered to Belgium and imported medicinal products.
Nitrosamines in medicinal products: templates and web forms for submitting the results of confirmatory tests
Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments (step 1) must be reported via the particular web form before 1 October 2020. Another particular web form is available for submitting the results of the confirmatory tests (step 2).
Coronavirus: newly updated guidelines for verifying the compliance and suitability of surgical face masks
The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. These guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) advises patients and citizens not to use unregulated cell therapies, which may be unsafe or ineffective.