Rules on prevention of falsified medicines - safety features

The EU has issued rules on prevention of falsified medicines that are to apply from 9 February 2019 (see namely Commission Delegated Regulation 2016/161).

Denmark has revised its Executive Order on Labelling etc. of Medicines (Danish language) to reflect the change in rules concerning safety features.

Some of the rules are a reiteration of the EU rules that already directly apply - however, they are included for practical purposes. It should be noted that Denmark has used its discretionary powers to allow for all types of medicinal products to have an anti-tampering device.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2018 Issue (Thomson Reuters).

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