SMVO response to the Ordinance on the unique identifiers and safety devices on the packaging of medicinal products for human use

Original response text:

The SMVO (Swiss Association for the Verification of Medicinal Products) expressly welcomes the mandatory implementation of serialization in accordance with Article 17a nHMG and the associated ordinance provided for in this draft.

In the view of the SMVO , the ordinance makes a significant contribution to increasing patient safety in Switzerland. At the same time, it acts as a catalyst for the urgently needed digitalization of supply and dispensing processes in the Swiss healthcare system.

As requested in the Ettlin motion (22.3859), the content of this revised ordinance has been adapted to the European Falsified Medicines Directive (FMD).

For methodological and legal reasons, the updated Regulatory Impact Assessment RIA) does not provide any additional insights. It is one-sided, as it is based on retrospective data and focuses exclusively on possible costs and negative effects of the regulation, while positive effects such as quality improvements, digitalization and patient safety are largely ignored. This ignores the fact that the investments in the system have already been made and that the required standards correspond to the global trend in the area of drug safety and traceability.

As a leading pharmaceutical location, Switzerland in particular cannot and must not ignore this international trend. On the contrary: with the SMVS and the expanded use of the underlying standards, Switzerland can play a pioneering role - for example through the complete digitalization of recalls or the intelligent use of data for the predictive control of supply chains and to improve security of supply.

Switzerland benefits from the EU's many years of experience in applying and improving the system. The SMVO supports stakeholders in Switzerland with the introduction and use of the SMVS.

With its extensive experience of European implementation, the SMVO is particularly committed to ensuring that errors can be avoided during implementation and operational use. The aim is to ensure the smoothest possible transition for those involved and to ensure the functionality and acceptance of the system right from the start.

The SMVO supports the Ordinance and its annexes in their entirety and advocates the swift entry into force of the Ordinance and Art. 17a TPA.