EU: New Delegated Regulation on safety features published

31 March 2016

On 9 February, the Commission published the Delegated Regulation on the safety features for medicines for human use – the last, but certainly not the least of several legislative measures the Commission set out to implement the Falsified Medicines Directive.
As a result of the Regulation, applicable as of 2019, medicines will be systematically authenticated before being supplied to patients, preventing the dispensing of falsified medicines and the accidental dispense of expired or recalled medicines. The European pharmaceutical supply chain will be digitalised, with a repositories system connecting manufacturers, wholesalers, pharmacists and hospitals (Health-EU Newsletter, 10 March 2016).
Click here for the full focus article.
Click here for Commission Delegated Regulation (EU) 2016/161.
Click here for more information about falsified medicines legislation.
Click here for more information about the NVC E-Course Pharmaceutical Packaging.

If you have any questions about this subject, please contact us:, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.