13/14 March 2024
The European Commission, the European Medicines Agency (EMA) and the Heads of National Medicines Agencies (HMAs) have agreed on a number of measures to mitigate the impact of the problems and challenges caused by the COVID 19 pandemic.
One interesting outcome is the question and answer document on regulatory expectations, which is updated regularly. One Q&A addresses the role and responsibilities of Qualified Persons (QPs) and remote batch certification. And these may be possible in certain circumstances: "The remote batch certification is permissible under EU GMP rules, provided that the QP has access to all information necessary to enable them to certify the batch."
While the document acknowledges that some Member States may have additional or different requirements that preclude remote certification, it also states that "considering the current restrictions of travelling linked to the COVID-19 pandemic, the remote certification should be acceptable in all EEA Member States".
However, there are no uniform regulations in the EU Member States. In some, remote certifications by the QP are allowed, in some MS not (yet) and in others it is unclear. In the meantime, certain flexibility is emerging and it is advised to contact the competent authority/ inspectorate.