Safety features of medicinal products

Regulation (EU) 2016/161 on Safety Features

On February 9, 2019, the regulation of the European Commission (EU) 2016/161 of October 2, 2015, amendments to 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 (hereinafter referred to as “the Regulation”) entered into force.

The main scope of the Regulation is twofold. Firstly, all medicinal products subject to prescription shall bear safety features on their packaging (unless included in the list set out in Annex I to the Regulation). Secondly, the Regulation covers the establishment of repository systems covering the entire EU/EEA.

Further information will be provided as required by the Icelandic Medicines Agency, tel. +354 520 2100 or email [email protected]

Last updated: November 23, 2023
Var efnið hjálplegt Yes No

Hvað þarf að laga?