Insights | December 3, 2018

Mandatory safety features of medicinal products for human use become applicable in February 2019

Pursuant to the Delegated Regulation of the European Commission (2016/161), packaging of medicinal products put on the Finnish market and intended for human use must include safety features from 9 February 2019. The Regulation is based on Article 54a of Directive 2001/83/EC on the Community code relating to medicinal products for human use. The aim of the features is to increase product safety and traceability and to prevent circulation of counterfeit medicines. February 2019 marks the end of a 3-year transition period given for the adoption of the new requirements.

The safety features must be added to all prescription medicinal products as well as to medicinal products not subject to prescription if they are mentioned in the Delegated Regulation.  Detailed instructions are provided in the Regulation. The safety features are a package-specific unique identifier (both machine and human readable) and an anti-tampering device. The unique identifier enables verification that the product is authentic and allows tracking and identification of individual packages. The anti-tampering device can verify if the packaging has been tampered with. The identifiers must be checked in all phases of the supply chain.

Fimea should as a point of departure be notified 90 days before the amendments are made. However, when it comes to the anti-tampering device, no separate 90-day notification is needed if the layout of the label does not change. No notification is needed for unique identifiers either if they fulfil the more detailed criteria set out by the Finnish Medicines Agency (see link below).

More detailed instructions are available from Fimea and updates of product information can be submitted to Fimea. Read more here.