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
On 26.9.2023, the Federal Parliament passed the motion of Council of States member Erich Ettlin 22.3859 "Master plan for digital transformation in healthcare. Use of legal standards and existing data".
Among other things, the Federal Council was instructed to make the application and verification of safety features and devices - the same as in the EU - mandatory in the ordinance on individual identification features and safety devices on the packaging of medicinal products for human use.
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.