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Serialisation and traceability, the fight against counterfeiting continues

On 9 February 2019 Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC, on the Community code relating to medicinal products for human use, become effective.

The Directive was born out of the need to prevent the entry into the legal supply chain of falsified medicinal products and to contrast with efficacy the increasing number of counterfeited products on the market.

The term “falsified” refers to drugs containing ingredients whose quality is below the average, where some ingredients are missing or containing ingredients with an incorrect dosage, including active substances.

All these cases are a serious threat to public health.

The experience acquired in this field show that these medicines reach the patients not only through illegal channels, but also via the legal supply chain and this represents a risk for human health that may determine very serious consequences from their administration as well as a lack of trust by patients in front of the legal supply chain.

The European Medicines Verification System

It was therefore considered suitable to amend Directive 2001/83/EC to face such growing threat.

The European Medicines Verification System (EMVS) allows the tracking of the path of a drug from its manufacturing up to the purchase by the final consumer.

Each manufacturer is in fact requested:

  • to print a Data-Matrix code embedding a unique identifier, including in turn 4 key elements:
    • the manufacturer’s product code (GTIN, NTIN or a national market code, with no less than 50 characters);the batch number;the expiry date;
    • the Serial Number (either randomised, or numeric or alphanumeric);
  • to apply an anti-tampering seal on each sale pack.

These actions concern the so called “secondary packaging”, containing in turn an immediate packaging (the one in contact with the medicine itself).

Manufacturers are bound to upload unique information for each product via the European hub, that will transmit it to the respective national systems where the verification of the medicinal product will be performed.

Therefore, each European country (European Union, European Economic Area and Switzerland) shall implement a national verification system (NMVS, National Medicines Verification System) that will be instituted and managed by a National Medicines Verification Organization (NMVO).

Upon dispensation, in fact, a medicine pack is scanned, controlled and verified to ensure its authenticity. If the unique code reported on it contains the information present in the database, the pack is decoded and delivered to the consumer. If, on the contrary, a warning is displayed by the system, the pack will not be dispensed.

Italy has been granted with a 6-year exemption, as a national traceability system is already in place.

Serialisation” is to “traceability” as Europe is to Italy.

In view of the entering into force of the Regulation, scheduled in Italy in 2025, discussions are taking place between the stakeholders currently involved in the process: the Ministry of Health, the Ministry of Economy and Finance, the Italian Medicine Agency, and the IPZS (Istituto Poligrafico e Zecca dello Stato, the State Printer and Mint).

The idea is to preserve the positive peculiarities of our system as much as possible, and to consider a postponement of the regulation’s implementation process.

The current traceability system has been in use for many years and is well consolidated. For this reason, alternative options are under consideration: on one hand, an indefinite postponement of the regulation implementation, on the other the hypothesis, recently formulated by an IPZS study, to find solutions via a hybrid system that would not hinder the necessary harmonisation with the European regulation but at the same time would not lose the value of flow controls.

Di Renzo Regulatory Affairs can support companies within the drug traceability and serialization process: for more information you can contact us at bollini@direnzo.biz.

Written by: Alessia Del Duca and Giordana Mastrosanti on 02/03/2023

Foto di Thomas Breher da Pixabay