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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.

The following persons are available for questions related to the SMVO or the project management:

Nicolas Florin
nicolas.florin@smvo.ch
Telefon +41 79 357 9386           
Erwin Zetz       
erwin.zetz@smvo.ch
Telefon +41 76 322 5681

 
Please use the contact form for you inquiry.

The operation of the entire verification system is ensured by the European Medicines Verification Organization (EMVO) and National Organizations (NMVOs). The financing of the system is largely supported by the pharmaceutical industry. The European and national organizations operate according to "Not for Profit" (NPO) principles.

The following organizations and systems must be financed to run the whole system:

  • The EMVO (European Medicines Verification Organization) is financed by the European stakeholder associations.
  • The EMVS (European Medicines Verification System) is funded with contributions from OBP (Onboarding Partners). In the operational business, contributions from national verification organizations are added.
  • The SMVO (Swiss Medicines Verification Organization) is to be founded at the beginning of January 2018. In a first step, funding is provided through national stakeholder associations. In addition, contributions will be made by SMVS (Swiss Medicines Verification System).
  • The national SMVS (Swiss Medicines Verification System) is financed by the MAHs.

The company-specific costs for the installation of the safety devices and the establishment of the check-in and the check-out are the responsibility of the individual company.

The amount of contributions to the SMVO and SMVS will be announced in due course.

All SMVO stakeholder associations can actively contribute to shape the processes during the pilot implementation phase. The processes will be designed in cooperation with the stakeholders and work will be planned and executed from the implementation team. It is planned to establish appropriate workgroups where pharmacists, doctors, hospitals or wholesalers can participate and contribute. 

The data contained in the individual platforms belong to the user who generates this data during his activity in the verification system.

The data generated by the issuing office (doctor's office, hospital or pharmacy) (e.g. the scanned GTIN, serial number) are used exclusively for the de-activation of the delivered package in the local system or in the EU hub. No personal data will be stored. Data owners can use the data for their purposes (e.g., for warehouse management).

The system is operated in accordance with these requirements and compliance with these requirements is ensured by means of appropriate safety precautions, a quality management system, as well as by appropriate controls by the national authorities and the EMVO.

First of all, the manufacturer loads the product data into the EU system (check-in).

The EU regulations clearly define when a product is to be deactivated (check-out). This happens at the end of the supply chain, when a drug is delivered to the patient. Then the product is checked for its authenticity by the service provider (pharmacy, hospital, doctor's office, etc.)  and the product will be deactivated in the database system.

The end-to-end verification process is supplemented by "risk-based verifications" e.g. at wholesalers. A risk-based verification can be performed in the case that a wholesaler has not received the product from the original manufacturer or from a pre-wholesaler. For example, when he receives the goods from another wholesaler, or as a return from a pharmacy.

If the product is affected by a callback, the code is deactivated and marked as «recalled».

One year after the expiry date, the code is automatically deactivated.

The following data is stored:

Basic data:

  • The master data (product code, form, dosage, target market), the MAHs, lot / batch number, expire date and serial number of the products are stored in the EMVS (EU hub).
  • In the National System (SMVS), registered user data of the service providers are registered for the check-out process.

Transactionional data:

  • The EU Hub is notified when a product has been disabled.
  • The national system stores when a product has been deactivated. Recognized counterfeits are also stored.

It is important that the data always belong to the one who created it and is not passed on, except for example. for official purposes in the event of a forged counterfeit. A third use of data is not possible.

No, the systems are verification systems for serialized drugs.

NTIN stands for National Trade Item Number. In Switzerland, NTINs (prefix 7680) are as unique as GTINs.Compared to a GTIN, the Swiss NTIN contains the 5-digit Swissmedic approval number. The difference to a GTIN is that its definition, lifecycle and allocation are determined by the refdata foundation.

This timeline is not binding for the implementation in Switzerland, as the corresponding legal base is not yet entered into force in Switzerland. The Principality of Liechtenstein must await the process of taking over the act in order for this regulation to become valid. For the overall project, the connection of the Principality of Liechtenstein would be a very good pilot project.

It it expected that medicanal packs bearing the security features will soon be available in Switzerland.

The following abbreviations are recommended:

Abbreviation

Definition

Comment

GTIN

Global Trade Itrem Number

The "unique identifier" required by the EU includes the Product Code and the Serial Number.

In Switzerland, a GTIN is used to identify the Product.

EXP

Expiry Date

LOT

Lot/Batch Number

SN Serial Number

Beispielanordnung Barcodes Schweiz

Example: Pack with EAN-13 barcode and GS1 Datamatrix barcode with recommended Human Readable Interpretation (HRI) next to the 2D Barcode.

Basically yes, but for printing related reasons, this approach is not recommended as it can lead to shifts in the print output, which can lead to defective production. It is recommended to provide the corresponding abbreviations together with the Datamatrix code.

With regards to the submission to swissmedic for changes to the packaging materials, the status is as follows:

  • Swissmedic has expressed its intention to move away from the existing mechanisms and obligations for the submission of amendments requiring approval and reporting as part of the amendment of the regulations to the revised Medicinal Products Act, and to reintroduce the EU Regulation in Switzerland.
  • A finale statement by Swissmedic is still pending.
  • In the EU, the path is clear for EMA-approved products. However, the country-specific implementation of decentralized products does not appear to be quite uniform. CMDh, the Co-ordination Group for Mutual Recognition and Decentralized Procedure, is seeking pragmatic solutions.

No, EAN-13 is a symbology, a data carrier, or a scannable barcode that contains the GTIN as encoded information.

In the future, the EAN-13 will be replaced by a GS1 Datamatrix barcode, where the GTIN, Lot / BatchNumber, ExpiryDate and Serial Number can be encoded.

The Global Trade Item Number (GTIN) is a globally unique product number that is built according to the standards of the global GS1 organization. The GTIN is one of the EU-recognized product identification numbers, which serve as the basis for the unique identifier.

The number assignment is based on the Healthcare GTIN allocation rules. Further information on the GS1 system can be found at www.gs1.ch/gesundheitswesen.

Yes. During a transitional period, this is also recommended to ensure that processes that do not yet support 2D barcodes continue to work.

The Swissmedic number must either be printed in human-readable form on the pack or printed in a 1D barcode with the 7680 prefix in a human-readable form.

Beispielanordnung Barcodes Schweiz

Example: Swissmedic Number with Prefix 7680 encoded in the EAN-13 barcode

Swissmedic Nummer Beispiel 2

Example: Swissmedic Number (stand alone)

No. A product must be clearly identifiable. Two different GTINs would lead to problems in all handling processes.

Beispielanordnung Barcodes Schweiz

Good Example: Identical GTIN or NTIN in the EAN-13 barcode and in the Datamatrix barcode

No. An NTIN is a valid identification number according to GS1 standards and does not necessarily have to be changed. Changing the NTIN to GTIN would have an impact on the supply chain processes and should only be done once the impact has been analyzed and it can be ensured that existing processes continue to run smoothly.

The first point of contact for manufacturers is the website of the European Medicines Verification Organization (EMVO): www.emvo-medicines.eu.

 

The data format for the upload is not publicly available. This information is provided to the manufacturers in the context of the so-called boarding process. Please contact EMVO to get more information about the boarding process.

Das europäsiche Verifizierungsnetzwerk

The European Verification Network

 

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