Making prescription-only medicines safer against counterfeiting is the aim of the implementation of the Delegated Regulation (EU) 2016/161. This will be accompanied by new EU-wide security features for pharmaceutical packaging and a comprehensive data storage system for all EU and EEA member states.

All EEA member states are connected to the EU-Hub

The national systems of all EEA member states and of Liechtenstein/Switzerland are connected to the EU-Hub since 9 February 2019. From now on, counterfeiters will no longer be able to smuggle their - sometimes life-threatening - imitations of medicines into the legal supply chain.

Legal situation in Switzerland

In order to guarantee an equivalent level of protection against counterfeit medicines in Switzerland, Art. 17a of the Swiss Medicines Act (HMG) stipulates that this should be integrated into the Swiss Therapeutic Products Act. The entry into force of this article together with the corresponding ordinance is expected during 2023. Contrary to EU law, the attaching of safety features and their examination in accordance with Art. 17a HMG is still voluntary. More about the legal base in Switzerland.

The role of the SMVO

The "SMVO Swiss Association for the Verification of Medicinal Products" (SMVO) was founded on 4 April 2018 with the aim of establishing a national data repository for Switzerland and Liechtenstein. The association is also committed to ensure that the future ordinance provides for a binding implementation of Art. 17a HMG. More about SMVO.

The role of the involved organisations and persons

The involved organisations, such as pharmacies, hospital pharmacies, doctors, pre-wholesalers, wholesalers, blistering service providers and software providers, play an important role in this. A summary of the relevant roles and responsibilities can be found here.