The work of the SMVO is part of a series of measures that the European Union and the Swiss Federal Council have set out to protect patients against counterfeit medicines in the legal supply chain. The legal basis for this is the Falsified Medicines Directive 2011/62/EU, the Delegated Act (EU) 2016/161, as well as Art. 17a HMG and the associated ordinance. Art. 17a HMG will enter into force together with the Regulation, presumably in the course of 2019.

With the publication of the delegated act in the Official Journal of the European Union on February 9, 2016, the implementation period for the development of the system for authentication began and ends for the EU countries on February 9, 2019.

As of this date, pharmaceutical companies will only be allowed to market prescription drugs in Europe with two safety features. Prescription-only medicines may then only be handed over to the patient after successful authentication.

Further information can be found under the following links:


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