COVID-19

The COVID-19 pandemic is having a significant impact on European regulatory activity. Many pharmaceutical companies are being directly and indirectly affected by this global situation and had to modify their working procedures and/or regulatory activities to respond to the demands. Likewise, many National Competent Authorities are carrying out a prioritisation of activities in order to cover the needs that the current situation demands.

The European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have assessed the situation and agreed on a number of measures to facilitate the management of marketing authorisations for veterinary medicinal products.

The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.

With this objective the European Commission, in collaboration with the network of Agencies, published questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic:

https://ec.europa.eu/food/sites/food/files/animals/docs/ah_vet-med_covid-19_qandas.pdf

The CMDv has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures :

https://www.hma.eu/fileadmin/dateien/Veterinary_medicines/CMDv_Website/COVID-19/CMDv_proposal_for_guidance_on_MR_DC_procedures_during_COVID-19.pdf)

Both documents will be updated and supplemented with additional information as appropriate.

Business continuity plan for the European medicines regulatory network

The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority for the European medicines regulatory network. EMA, together with EU Member States and the European Commission, has published a plan outlining principles for how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out during the ongoing COVID-19 pandemic.

For more information please refer to the joint HMA/EC/EMA press release here

More information EMA’s governance during COVID-19 pandemic