Counterfeit medicine

New counterfeit guidelines for medicines since 2019 – prevent counterfeit medicines

All medicines are subject to and require the highest level of security, but are repeatedly put at risk by counterfeiters. Counterfeit medicines can contain medicines with incorrectly declared, diluted or even missing ingredients. Deceptively authentic packaging or repackaging in original boxes misleads retailers and patients about the actual contents. Counterfeits are usually manufactured and sold much cheaper than the genuine original preparations. According to an estimate by the American FDA (Food and Drug Administration), over 10% of all medications in circulation worldwide are counterfeit. The possible consequences that result from this: Patients believe they are taking the right medicine and unknowingly take ineffective or even harmful substances or active ingredients, with potentially drastic consequences for their health. The anti-counterfeit guidelines for medicines required by the World Health Organization, which many countries are currently introducing, are long overdue - and rapid compliance is in the interest of all reputable pharmaceutical manufacturers. For several years now, legislators have been resolutely countering the dangers of counterfeit medicines for consumers and companies by issuing national and supranational counterfeit guidelines. By quickly implementing anti-counterfeiting guidelines, pharmaceutical manufacturers and packaging service providers can ensure that their products continue to be sold seamlessly and counterfeit cheap products (illegal medicines) are reliably removed from the market.

From 2019: Medicines only with 2D barcodes

From February 9, 2019, pharmaceutical companies will only be allowed to market prescription drugs with two new safety features on their packaging. Each package then needs an individual serial number and a seal that shows whether the packaging is intact. This includes a barcode, the so-called data matrix code, as an individual identification feature, which pharmacists have to scan when dispensing the medication. This ensures that the package in question is neither counterfeit nor stolen. In this way, the authenticity of a tablet pack can be checked. The aim of these European regulations from 2011 is to protect patients from counterfeit medicines. In addition, a new, central verification system should make it possible to track at any time which route each individual medication has taken before it ends up in the pharmacy. To do this, all drug data from the place of manufacture is transferred to a database with which all pharmacies, manufacturers and suppliers are ultimately connected and networked. According to the new EU regulation, if pharmacists hand out medication to the patient, they must check again to be sure whether the medication is genuine using the printed data matrix code. To achieve this, all German pharmacies must have a 2019D barcode scanner by 2 at the latest.

Sealing provides additional protection

For preparations for the German market, the code contains a serial number and a product code (with an integrated pharmaceutical central number), as well as the batch number and the expiry date. The information must also be printed in plain text. In addition, each package must be sealed to ensure that unauthorized removal – and possibly adulteration – cannot occur. The current EU regulation provides in great detail where and how the security features are to be applied and how the barcode data is stored - a sometimes not insignificant effort for pharmaceutical companies, as many internal processes are affected by the new serialization process, including the IT department, production and quality management.

Tamper-Evident closure for 2019: Special feature of the EU Counterfeiting Directive

The so-called tamper-evident closure is required for prescription medications in countries that are subject to the EU Falsified Medicines Directive from February 9, 2019. The seal makes subsequent manipulation of the packaged medication impossible and also prevents counterfeit medication from being hidden in the original packaging. Important is. that if the seal is damaged during sale or has already been opened, it may not be passed on to the customer.

With a few exceptions, only prescription preparations that have a 2D barcode printed on the package may be brought onto the market. Goods that are already on sale may be sold. For preparations for the German market, the code contains a serial number and a product code (with an integrated pharmaceutical central number), as well as the batch number and the expiry date. The information must also be printed in plain text. In addition, each package must be sealed to ensure that unauthorized removal – and possibly adulteration – cannot occur.

drug

A special DataMatrix code plus packaging sealing will ensure that medicines can no longer be counterfeited in the future.

Pharmacies have to convert now to be ready for 2019

The aim of the new drug counterfeit guidelines is to make it traceable at any time through the individual serial number with up to 20 characters. This means that it can be determined at any time what happened to a medication until it finally arrives at the pharmacy. From 2019 onwards, their task will be to do so again when dispensing a prescription product to a patient Authenticity and integrity must be checked – and this is mandatory for every medication packaging! As a result, all pharmacies must be open by 2019 be equipped with a 2D scanner at the checkout. By then, the software must be able to compare the recorded data from the 2D code with that in the manufacturer data pool via the Internet in the shortest possible time at the sales counter so that the package can be approved as genuine and handed over to the customer. A separate system was set up for pharmacies specifically for this purpose, through which anonymous requests and responses go to the manufacturer database. The serial number is then removed. Further use would trigger a counterfeit alarm.

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Different countries, different labeling of medicines

Pharmacy-2D_Barcode

All anti-counterfeiting guidelines require an individual product identification number on the respective medication. In addition, most of the guidelines include the expiry date for the medication, as well as a batch number and, if necessary, a serial number. However, the format in which this marking is done can vary greatly. However, human-readable plain text and a machine-readable barcode must always be included. The same applies to the type of product identification number - the GTIN format of GS1 is often required or an ID number in NTIN or country-specific formats is required (such as PPN in Germany, CIP in France, KDC in Korea, CNK in Belgium, AIC in Italy, etc.). The product identification number usually contains the following information: a country prefix, the company number, the article number and a check digit.

The National Trade Item Number (NTIN)

The National Trade Item Number (NTIN) is a globally unique 13-digit healthcare number. In Austria, the PZN is part of the NTIN (also known as the PZN EAN code). The structure of the NTIN (National Trade Item Number) with the Austrian pharmaceutical central number (PZN) can be seen in the following graphic:

NTIN code

Global Trade Item Number (GTIN)

GTIN codeCompared to the National Trade Item Number (NTIN), which can only be found on medication packaging, the Global Trade Item Number (GTIN), which can be found on all other products and packages, is different. The Gloabl Trade Numer is an identification number managed and assigned by GS1 that can be used to uniquely identify products and packages worldwide. It is the current name for the European Article Number (EAN), which was in use until 2009. The principles behind it are set out in ISO 28219 and ISO 22742. In practice, the GTIN is often equated with the barcode in which the number is encoded. It is correct that the GTIN is a unique identification number (which is defined independently of the data carrier). Typically, the GTIN is encoded into a barcode of the EAN/UPC type (ISO/IEC 15420). Other coding options include: B. Code 128 (ISO/IEC 15417), Data Matrix (ISO/IEC 16022) and Interleaved 2 of 5 (ISO/IEC 16390). In some cases, the GTIN is embedded in a data structure. The GS1 organization invented the terms GS1 DataMatrix and GS1 128 to identify the combination of code (data carrier) and data structure. The GS1 organization in the respective country is responsible for the award.