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Regulatory Focus™ > News Articles > 2 > Falsified Medicines: European Commission Says Most Member States are Assessing Penalties

Falsified Medicines: European Commission Says Most Member States are Assessing Penalties

Posted 26 February 2018 | By Zachary Brennan 

Falsified Medicines: European Commission Says Most Member States are Assessing Penalties

The European Commission has published a report finding that EU member states have satisfactorily strengthened their laws to assess penalties for companies falsifying medicines, active substances and excipients.

A total of 26 (of 28) member states have introduced changes to their legislation setting up imprisonment, fines and/or administrative sanctions (e.g. the revocation of licenses or seizure/withdrawal of unlawful products from the market) for such falsified medicines.

For example, maximum prison sentences for the falsification of medicines range from one year (in Sweden, Finland and Greece) to 15 years (in Austria, Slovenia and Slovakia), and maximum fines range from €4300 in Lithuania to €1 million in Spain to unlimited in the UK.

And 21 member states have made sure that the manufacture, distribution, brokering, import, export and sale at a distance of falsified medicines all attract criminal penalties.

“Member States’ transposition of Article 118a of Directive 2001/83/EC is satisfactory,” the report says in its conclusion. “To further reinforce measures in place and strengthen their overall effectiveness, certain Member States could consider introducing additional criminal penalties or administrative sanctions in relation to falsified medicines, active substances or excipients.”


In 2011, the European Parliament and the Council adopted the Falsified Medicines Directive to better address increasing concerns regarding falsified medicines in the legal supply chain.

The directive will introduce mandatory safety features on prescription medicines beginning February 2019 (unless exempted), strengthens good distribution practices and requirements for wholesale distributors, reinforces rules on importation, controls and inspections of active substances and their manufacturers, and established an EU-wide logo as of 1 July 2015 to allow the identification of legal online retailers of medicines.

In order to ensure effective enforcement of these provisions, Article 118a of Directive 2001/83/EC requires member states to “lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and [to] take all necessary measures to ensure that those penalties are implemented. The penalties must be effective, proportionate and dissuasive.”


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