COVID-19 | EMA decided to extend the MLM Service

COVID-19 | EMA decided to extend the MLM Service

The European Medicines Agency (EMA), supported by pharmaceutical industry associations represented in the EudraVigilance Expert Working Group and by the Pharmacovigilance Risk Assessment Group (PRAC), decided to extend the Medical Literature Monitoring (MLM) service to cover substances used in products of interest in the COVID-19 context, in order to reduce the burden on the Marketing Authorisation Holders (MAHs) of these products and to mitigate the risk to pharmacovigilance activities.

Therefore, from 1 June 2020 the scope of the MLM service is being extended to cover also the following nine substance groups: EMTRICITABINE + TENOFOVIR; PREDNISONE; CHLOROQUINE; DARUNAVIR; RITONAVIR; IVERMECTIN; NITRIC OXIDE; FILGRASTIM; OSELTAMIVIR.

If your organization is a MAHs of one or more products containing one or more of the substances listed above, from 1 June 2020 you should no longer submit any ICSRs to EudraVigilance for any of these substances or substance combinations.

Asphalion’s pharmacovigilance team can support you with the screening of MLM service and the literature searches for your products. If need any help, contact us at

COVID-19 | AEMPS will carry out remote inspections of Good Practice in Pharmacovigilance
Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”