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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).

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).

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: 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.

Nitrosamines in medicinal products: report results of risk assessments for impurities

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.

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