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    Legal Base

    The work of SMVO is in the context of a series of measures specified by the European Union and the Swiss Federal Council to protect patients against counterfeit medicines in the legal supply chain. The legal basis for this is the Anti-Counterfeiting Directive 2011/62/EU, the Delegated Regulation (EU) 2016/161, as well as Art. 17a HMG and the associated Ordinance. Art. 17a HMG will enter into force together with the regulation.

    Status of the implementation in Europe

    With the publication of the Delegated Regulation on 9.2.2016 in the Official Journal of the European Union, the implementation period for the establishment of the system for authenticity verification has started. It ended for EU countries on Feb. 9, 2019.

    As of this date, pharmaceutical companies may only release medicines subject to verification for marketing in Europe with two safety features. Since then, prescription drugs may only be dispensed to patients after successful authenticity verification.

    Status of the implementation in Switzerland

    On Sept. 11, 2017, the Swiss parliament passed Art. 17a HMG to implement the Medicrime Convention. The legislative article is to enter into force at the same time as the "Ordinance on the Individual Identification Marks and Safety Devices on the Packaging of Medicinal Products for Human Use". The public consultation on this regulation has been closed since 5.2.2020.

    Due to the corona pandemic, the responsible Federal Office of Public Health (FOPH) experienced delays in the further processing of the ordinance, namely the consultation report of the Federal Council and the adjustments in the ordinance in line with the consultation results are not yet available.

    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 - for mandatory in the ordinance on "individual identification features and safety devices on the packaging of medicinal products for human use".

    With the use of existing data sources and existing regulatory standards by all stakeholders, as well as with the linking of the National Verification System to the European Medicines Verification System, there will be rapid progress and cost savings because there will be no need to create new systems from scratch.

    It is to be hoped that the FOPH will now make rapid progress in the creation of the regulation, and that appropriate implementation deadlines will be set and the implementation costs adequately taken into account. Then nothing will stand in the way of the entry into force of Art. 17a HMG at the same time as the ordinance.

    Because the data in the SMVO can also be used for other purposes under certain circumstances, such as the management of supply bottlenecks for medicines, the completion of the SMVO represents an important step in the digitization of the Swiss healthcare system.

     

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