A Q&A document has been made available by the European Commission to provide guidance to MAHs, including clarifications regarding the regulatory expectations and flexibility for COVID-19 treatments.
Speed-up of the marketing authorization
The coordination group:
- promotes the use of zero-day mutual recognition procedure/repeat use procedure to expand national marketing authorizations to new Member States (MS)
- allows MS to authorize a medicinal product already authorized in another EU MS
When no centralized/relevant national marketing authorization exists, other possibilities are:
- compassionate use
- authorization of the distribution of an unauthorized medicinal product according to Article 5(2) of Directive 2001/83/EC
Exceptional change management process (ECMP)
To avoid supply chain/manufacturing disruptions due to COVID-19 pandemia and to ensure continuity of crucial medicines for treatment of COVID-19 patients, an exceptional change management process (ECMP) is made available to MAHs.
The ECMP will permit the swift implementation of suppliers and/or manufacturing/control sites changes to reduce the risks of shortages, deferring the full assessment of the variation.
If MAHs are facing difficulties to perform the quality controls foreseen in the marketing authorization due to the COVID-19 pandemic scenario, they can contact the competent authorities and present as a variation procedure an adapted control scheme based on a risk-based approach.
Regulatory Pharma Net is fully available to provide support for the practical implementation of these special procedures.