On the implementation of the Falsified Medicine Directive (FMD) in Switzerland:
As part of the revision of the Therapeutic Products Act (TPA), a number of
measures defined. The specifications were made by the European Union
and the Swiss Federal Council and aim 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
TPA and the related ordinance, Art. 17a TPA.
These new regulatory requirements only affect RX drugs, i.e.
Medicine products assigned to Swissmedic Lists A and B.
Effects due to Corona
Due to the Corona pandemic, the FOPH is currently unable to issue any binding
statement when the ordinance on Article Art. 17a TPA will enter into force.
The FOPH has received the comments on the relevant consultation
Individual recognition features in the supply chain
identification features and safety devices on the packaging of
More information on the topic
A pseudo-randomized Serial number serves as a recognition feature
on each secondary packaging, which is printied by means of a GS1 DataMatrix barcode and an HRI (Human Readable Interpretation).
Parallel to this, a verification system is being set up in which the
manufacturers upload their serial number information before the products
come into the supply chain.
When dispensed at the pharmacy, hospital or doctor's office, the
Data element on the package checked against the verification system
and the respective package in the database as consumed
marked. This system allows testing at all stations
of the physical flow of goods and thus prevents the penetration of the
neat supply chain with counterfeit products.
The safety devices on the packaging include in particular
that in the future only packaging will be placed on the market
be allowed to be "tamper proof" (first opening guarantee), i.e. a
Packaging must be designed in such a way that it cannot be resealed.
The GS1 system allows medication and patient safety and
simplifies the documentation in clinical
information systems and increases the efficiency of the clinical
patient pathway and the supply chain.
- The GS1 system is the basis for the digitization of the
- GS1 identification keys are used to identify pharmaceuticals,
Patients, caregivers and locations clearly identified.
- With GS1 barcodes, identification and attributes are printed on every
Object made available in machine and human readable form.
- With the master data exchange standard GDSN (Global Data
Synchronization Network), master data can be shared across multiple parties and there is no need for time-consuming
- The GS1 EDI standard simplifies the digitization of the