Article 118a of Directive 2001/83/EC requires Member States to lay down “effective, proportionate and dissuasive” penalties for those who are involved in the manufacturing, distribution, brokering, import and export of falsified medicinal products. On 26 January 2018, the European Commission published a report on how this requirement has been met by individual Member States, based on a detailed study performed by external contractors, empirica and  ZEIS, on behalf of the DG for Health and Food Safety.

The report indicated that 26 Member States had amended their legislation to accommodate new penalties for the falsification of medicinal products. The exceptions were Hungary, which changed its Criminal Code as a result of the Council of Europe Medicrime Convention, and Finland, which already had penalties in place before Article 118a took effect.

In 21 Member States, the manufacturing, distribution, brokering, import and export of falsified medicinal products attracts criminal penalties. In the remaining Member States (Bulgaria, Finland, Latvia, Romania, Poland, Sweden and Lithuania) only certain infringements are considered criminal.

Continue Reading Commission Survey on National Penalties for Breach of Falsified Medicines Rules in EU Member States

One of the obligations imposed on Member States under the Falsified Medicines Directive 2011/62/EU (FMD) is to put in place a medicines verification system by 9 February 2019. In the UK this is being managed by Securmed UK, a non-profit organisation established by the relevant supply chain stakeholders.

On 19 July 2017 Securmed UK announced that it had entered into a letter of intent with Arvato Systems GmbH to provide the IT platform that will underpin the UK’s medicines verification system. This represents a key milestone in the UK’s journey to meeting its obligations under the FMD and associated Delegated Regulation 2016/161.

Continue Reading Arvato to implement UK falsified medicines verification system