Council of Europe Convention, revision of the Therapeutic Products Act

After Parliament approved the "Federal Decree on the Approval and Implementation of the Council of Europe Convention on the Falsification of Medicinal Products and Medical Devices and on Similar Crimes Dangerous to Public Health" - the Medicrime Convention - on 29.09.2017 and adopted Article 17a of the Therapeutic Products Act (nHMG), the Medicrime Convention was ratified by Switzerland on 25.10.2018.^[1]

 ^[1] BBl 2017 6301, https://www.coe.int/en/web/medicrime/the-medicrime-convention

Database system with connection to the EMVS

According to Art. 17a nHMG, the pharmaceutical industry must introduce a database system for the serialisation and deactivation of prescription-only medicinal products at its own expense. From the outset, it was important for Switzerland to be able to join the EU's Falsified Medicines Directive (FMD) for the protection of patients and as an important pharmaceutical supplier in Europe, in order to be able to guarantee safety standards in the pharmaceutical sector without duplication. This was achieved with the connection to the European Medicines Verification System (EMVS).

Mandatory serialisation for prescription-only medicinal products

The adoption of the motion by Councillor of States Erich Ettlin 22.3859 "Master plan for digital transformation in the healthcare sector. Use of legal standards and existing data" of 26 September 2023 by the Federal Parliament, the affixing and verification of safety features and devices on the packaging of prescription-only medicinal products for human use was declared mandatory - as in the EU.

Work on the ordinance is ongoing

In 2024, the Federal Office of Public Health (FOPH/BAG) resumed work on the ordinance on the unique identifiers and safety devices on the packaging of medicinal products for human use after an initial consultation had already been carried out in 2019, the continuation of which had been interrupted by other priorities due to the coronavirus pandemic.

The implementation process and schedule are expected to be as follows:

Figure: Provisional timetable for the entry into force of Art. 17a TPA and the Ordinance on the unique identifiers and
safety devices on the packaging of medicinal products for human use

The SMVS accompanies and supports all involved parties during the implementation process.

Reliable planning basis

Marketing authorisation holders, pharmacies, self-dispensing medical practices, hospitals, wholesalers and other healthcare facilities in Switzerland that dispense prescription-only medicines now have a reliable basis for planning the application of safety features and the uploading of packaging data to the already productive Swiss Medicines Verification System (SMVS).

Smooth connection of end users to the SMVS

It is now a matter of using the time until the legal and regulatory provisions come into force to integrate the necessary technical and procedural adjustments for the serialisation of prescription-only medicines into the internal, periodic adjustment processes as far as possible.

SMVS cooperatively supports and assists end users and their software partners to ensure a smooth connection to the SMVS. The implementation of further benefits is also conceivable, such as FEFO "First Expired, First Out" or the automatic check of the dispensability of medicines.

Upload serialised packs to the EMVS

It is important that all marketing authorisation holders upload already serialised Swiss packs to the European Medicines Verification System (EMVS) now. This will prevent unnecessary alerts. By doing so, MAHs will support the smooth introduction of the database system for all users.