BfArM - Federal Institute for Drugs and Medical Devices
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If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
Risk Assessment Procedures
Here you will find information on the risk assessment procedures including national graduated plan procedures (“Stufenplanverfahren”). This list is compiled in a chronological order according to the date of the most recent update.
After clicking on the "search all risk assessment procedures" button, the total amount of all risk assessment procedures can be searched in the website search.
Active substance: bromocriptine
In its notice of 27 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission of 30 October 2014 regarding medicinal products containing bromocriptine.
Active substance: vgarious (in Germany parenteral iron sucrose)
The BfArM has provisionally ordered the suspension of the above-mentioned generic drug approvals in its decision of October 7, 2020.
Active substance: Pholcodine
The European Commission made its final legally binding decision on March 06, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European risk assessment procedure under Article 107i of Directive 2001/83/EC on medicinal products containing pholcodine.
Active substances: colistin | colistimethate sodium
Based on the review of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission decided on 16 December 2014 to update the product informations of medicinal products containing colistin and colistimethate.
Active substance: pseudoephedrine
With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.
Active substance: quinine
In its letter dated 19 December 2013, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has initiated a written hearing regarding the risk of serious haematological reactions, especially thrombocytopenias, associated with medicinal products containing quinine in the indication "treatment and prevention of nocturnal leg cramps".
Active substance: quinine
The BfArM issues information on a national graduated plan procedure ("Stufenplanverfahren") regarding the active substance quinine for the indication nocturnal leg cramps.
Active substance: ranitidine
The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of all holders of marketing authorisations for medicinal products containing ranitidine.
Active substances: acitretin | adapalene | alitretinoin | bexarotene | isotretinoin | tazarotene | tretinoin
The BfArM requires pharmaceutical companies to report annually all pregnancies reported in connection with the use of acitretin, alitretinoin and isotretinoin.