Falsified medicines: reporting obligations
For centrally authorised medicines, the European Medicines Agency (EMA) coordinates the exchange of information on (suspected) falsified medicinal product notifications.
A (suspected) falsified medicine is any medicine with a false representation of its:
- identity, including its packaging and labelling, and the name, composition and strength of any of its ingredients including excipients;
- source, including its manufacturer, country of manufacturing, country of origin and its marketing authorisation holder;
- history, including records and documents on distribution channels used.
Marketing and manufacturing authorisation holders are obliged to report to EMA if they detect any (suspected) falsification of a centrally authorised medicine that could pose a risk to public and animal health.
In addition, marketing authorisation holders of centrally authorised medicines should notify the national competent authorities of the Member States or third country authorities where the suspected falsified product is distributed.
EMA maintains a reporting system consisting of the falsified medicinal product report template . Marketing and manufacturing authorisation holders are required to use this template to notify EMA of:
- suspected and confirmed falsified medicines;
- suspicious offer(s) received.
The requirement covers notifying EMA of a confirmed incident of falsification flagged by the safety features repository system, as required by Article 37 of Commission Delegated Regulation (EU) 2016/161. The repository is part of an end-to-end medicines verification system introduced by the Regulation. For more information, see 'Legal framework' on Falsified medicines: overview.
For full instructions on how to report a falsified medicine to EMA, see:
For a (suspected) falsification of a nationally authorised medicine, marketing and manufacturing authorisation holders should notify the relevant national competent authority(ies).
Parallel distributors who identify a (suspected) falsified medicine should liaise directly with the marketing and manufacturing authorisation holders, to enable confirmatory testing of a sample of the suspicious units.
EMA has a coordinating role between the marketing authorisation holder and the impacted national competent authority(ies).
On being notified of a (suspected) falsified medicine, EMA informs the concerned national competent authorities, who are responsible for investigating the supply chain and deciding on any market action.
EMA also informs the parallel distribution network about confirmed falsified products or medicine theft. It does so proactively, in order to prevent reintroduction of illegal units into the supply chain.
If a notified event presents a serious risk to public and animal health, national competent authorities inform each other through the rapid alert system.
EMA is responsible for maintaining a rapid alert list of contact points, which includes national competent authorities in EEA Member States, the European Commission and international partner regulatory authorities and organisations.
For more details, see: