• Increased safety for patients
    Increased safety for patients

    New EU-wide safety features for medicines also increase patient safety in Switzerland.

  • Efficient detection of counterfeits
    Efficient detection of counterfeits

    Using unique serial numbers and bar code scanners, drug packs are identified and counterfeits are safely detected.

  • Investment for more security
    Investment for more security

    For all stakeholders in the health care sector: drug manufacturers, pharmaceutical wholesalers, hospitals, pharmacies, doctors and patients.

  • Optimal protection of the supply chain
    Optimal protection of the supply chain

    New security features: Serialized packs and additional manipulation protection for legally produced medicines increase the supply chain security.

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 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 sitituation 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 planned for 2020. 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 ensuring that the future ordinance provides for a binding implementation of Art. 17a HMG.
More about SMVO.

The role of the ivolved organisations and persons

The involved organizations, such as pharmacies, hospital pharmacies, doctors, pre-grosslists, 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.

 

Stabilization Phase agreed
The EU Counterfeiting Directive came into force on 9th of February 2019. In order to ensure a smooth start and a high supply level, a "stabilisation phase" was agreed for the first 6 months from 9. of Febuary 2019. During this period, all persons and organisations involved have the opportunity to identify and rectify any process and application problems. Data, software and handling problems should not lead to further consequences.

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