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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.

Killapods is considered to be a medicinal product

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.

EMA warns against use of unproven cell therapies

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.

Suspension of medicinal products containing ranitidine in the European Union

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the sale of all ranitidine-based medicinal products be suspended in the European Union. This is due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).

Coronavirus: Alternative Test Protocol (ATP) for surgical face masks

The FAMHP inspection services have noted that the surgical face masks offered do not have the declarations, certificates and test reports necessary according to European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed to ensure they can still be permitted for use as a surgical mask or comfort mask.

Coronavirus: the FAMHP seizes postal packages containing counterfeit and other illegal medicinal products against COVID-19

Criminal organisations are using the coronavirus pandemic to sell counterfeit medicinal products and other illegal medicinal products. The FAMHP asks patients to be prudent and be careful of internet deals.

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