General Questions

FAQs - General Questions

Each drug pack is equipped with a randomized (randomly selected) serial number which is encoded together with the batch number and expiration date in a two-dimensional GS1 Datamatrix barcode. This makes each medicine pack unique and traceable within Europe.

Before a drug is delivered to a patient, the serial number of the drug is checked (verified), read out and deactivated from a database. If the deactivated serial number appears again at a later point at a release point (e.g. a pharmacy),  a falsification is suspected. The medication is not delivered and there is no risk to the patient.

The project was requested by the representative associations of the pharmaceutical industry on the basis of the European Directive (Directive 2011/62 / EU and the delegated regulation 2016/161) and Swiss legislation, and is supported by all Foundation Council members of Refdata. The involved refdata representatives have actively participated in the project work so far.

The aim is that all the associations involved in the logistics supply chain, from production to product release to the consumer, participate in the establishment of an organizational structure for Switzerland. It consists of a Swiss Medicines Verification Organization (SMVO) and a system operating company (Swiss Medicines Verification System Operating Company (SMVS BG).) The Principality of Liechtenstein is also involved in this process and have a right to participate in the implementation.


The implementation takes place in 2 phases:


Phase 1
: Check-in: manufacturers have to be able to export into the EU zone (attach safety features to the package and upload data to the EU Hub)

Phase 2: Implementation in Switzerland and Liechtenstein by pharmacies, hospitals, SD doctors, homes and wholesalers etc., for drugs that are marketed in Switzerland or via Switzerland in Liechtenstein is currently still on a voluntary basis.

In Liechtenstein, the concept of "parallel marketability" applies. It states that both goods under EEA law and goods under customs contract law may be placed on the market in Liechtenstein territory. For drugs coming to Liechtenstein from the EEA region, testing is carried out via the control system implemented in Switzerland (SMVS).

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The SMVO acts as the governance body and defines the guidelines for implementation in Switzerland as well as the guidelines for the operation of the database system for the Operating Company (SMVS BG). Governance is also supplemented by official guidelines through swissmedic / BAG and by the European Medicines Verification Organisation (EMVO).

Here is a list of the most frequently used abbreviations and their explanation:

FMD – Falsified Medicines Directive (2011/62/EU)

EMVO – European Medicines Verification Organisation

EMVS - European Medicines Verification System

NMVO – National Medicines Verification Organisation

NMVS - National Medicines Verification System

SMVO – Swiss Medicines Verification Organisation

SMVS - Swiss Medicines Verification System

EMA -  European Medicines Agency

BOP – Business Onboarding Partner

MAH – Marketing Authorisation Holder

GTIN – Global Trade Item Number

LOT -  Lot/Batch Number

EXP – Expiry Date

Serial – Serial Number

The regulation concerns only RX drugs (Swissmedic for CH market). These products must be provided with safety features such as the 2D datamatrix code and a anti-tampering device.

Omeprazole is an exception, otherwise OTC drugs are not affected at the moment.

There will be different lists (white list, black list) in the countries. The relevant registration authority decides on the safety features. In Switzerland, swissmedic will be the responsible body for the list on the Swiss market. At the moment, there is no list for the Swiss market.

No, they are not affected and therefore do not have to participate either in the costs of the EMVO or in the costs of the SMVO / SMVS.

Pre-Wholesalers generally work on behalf of MAHs. The responsibility for the check-in or check-out process remains with the MAH and the organisations at the "point of dispense".

Switzerland could be misused as a "trading island" for counterfeit drugs. Therefore, products for the Swiss market must also be equipped with the security features (2D barcode with serial number and anti-tampering device).

It is assumed that the manufacturers also provide the Swiss market with products bearing the safety features as these products are running on the same production lines.

By implementing the EU guidelines in Switzerland, we contribute to an overall safer European system and reduce the risk that counterfeiting could come to our country and that Switzerland could be considered as a trading place for counterfeit medicines.

Further advantages: The patient safety can be additionally increased and processes along the supply chain and the medical processes can be automated. Furthermore, callbacks can be carried out much more efficiently and quickly, since the affected drugs are marked in the national system and displayed as blocked during the check-out process.

All manufacturers register as an OBP (On-Boarding Business Partner) with EMVO. This is called the "boarding process".  In addition, they must also register their national sales organizations (MAHs) with all National Medicines Verification Organizations (NMVOs) if they sell products in the relevant market.

Information is provided by the EMVO on its website https://emvo-medicines.eu.

registration en 

emvologo

 

 

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