Source: European Parliament
The COVID-19 pandemic was an unprecedented public health crisis which required facilitation of the development, authorisation and deployment of COVID-19 vaccines and treatments.
It was in this context that vaccine manufacturers requested a temporary derogation from serialisation requirements on the outer packaging of their vaccines to ensure continuous supply of the vaccine in the critical stage of the pandemic.
The derogation was granted, upon consultation with Member States under clearly specified conditions, including the obligation to report immediately any relevant incidents to ensure accountability and reconciliation of distributed products.
The derogation was granted on the basis on Article 63(3) of Directive 2001/83/EC[1] without prejudice to the manufacturer’s liability.
It should be also pointed out that the continuous monitoring of the quality, safety and efficacy of medicines was organised independently and not impacted by waiving the serialisation requirement.
Each batch was tested prior to its release by Official Medicines Control Laboratories of the Member States. Moreover, in the EU, a robust pharmacovigilance system is in place to collect and assess potential adverse drug reactions (ADRs).
EudraVigilance, the European database managed by the European Medicines Agency, compiles all ADR reports. Moreover, healthcare professionals were required to report ADRs for each patient following COVID-19 vaccination.
- [1] http://data.europa.eu/eli/dir/2001/83/oj