On 9 February 2016, the European Commission published Commission Delegated Regulation (EU) No. 2016/161, supplementing Directive 2001/83/EC of the European Parliament and of the Council, by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (“Delegated Regulation”).
It is recalled that, to prevent the entry of falsified medicinal products into the supply chain in the European Union (“EU”), the Falsified Medicines Directive (Directive 2011/62/EU) introduced certain obligatory safety features on the packaging of medicinal products for the purposes of determining their authenticity and impede the distribution of falsified medicinal products. The purpose of the Delegated Regulation is, therefore, to detail the characteristics of the obligatory safety features for medicinal products introduced by the Falsified Medicines Directive. The safety features consist of two elements placed on the packaging of a medicinal product:
- a unique identifier; and
- a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device).
A number of the requirements introduced by the Delegated Regulation are discussed within this briefing.