Status as of April 2024
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".
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.
Serialization becomes mandatory
The Ettlin motion was referred to the Federal Council by Parliament on September 26, 2023. According to its wording, the serialization of prescription-only medicines is to be made mandatory in Switzerland - as in the EU. The FOPH has communicated the following implementation process and timetable up to the opening of the second consultation on the ordinance on Art. 17a TPA:
Figure 1: Expected timetable for entry into force Art. 17a, TPA
From this, the SMVO concludes that the entry into force of the law and the ordinance could take place on 1.1.2026. A transitional period will probably be set until all products have to be serialized and decommissioned by the dispensing bodies.
Better planning basis for marketing authorization holders
Marketing authorization holders now have a basis for planning the application of safety features and the uploading of packaging data to the already productive National Medicines Verification System (NMVS) of Switzerland and the Principality of Liechtenstein.
This also applies to the end users of the system, such as pharmacies, medical practices with self-dispensing, hospitals, wholesalers and other healthcare facilities affected by Art. 17a TPA.
Smooth connection of end users to the NMVS
Together, we now need to use the time until the mandatory requirement comes into force to implement practicable solutions for the serialization of prescription-only medicines in Switzerland. We will support end users and their software partners in ensuring a smooth connection to the NMVS. Additional added value such as FEFO "First Expired, First Out" or automatic verification of the dispensability of medicines are conceivable.
Systematically upload serialised packs to the EMVS
To prevent unnecessary alerts for end users, it is important that all Swiss packs that have already been serialized are uploaded to the EMVS. This will support the smooth introduction of the NMVS in Switzerland and an error-free process in the overall European system.