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

On 22 November 2017, the European Commission adopted new guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). ATMP manufacturers must ensure compliance with these guidelines no later than 22 May 2018.

The guidelines seek to reflect the rapid technological and medical advancements being made in the field of ATMPs (i.e. gene therapies, somatic cell therapies and tissue engineered products), such as decentralised manufacturing for autologous products, automated production, outsourced reconstitution, and gene editing technologies such as CRISPR and immunomodulators. Currently, these new technologies must comply with the general GMP guidelines set out in Volume 4 of The rules governing medicinal products in the European Union. However, these products are often developed in an academic or hospital setting under quality systems different to those typically required for the manufacture of conventional medicinal products.

Continue Reading New guidelines on GMP for Advanced Therapy Medicinal Products

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