February 9, 2019 is an important date for the pharmaceutical industry. From that date, the obligation to affix a unique identifier to packages of medicinal products and to secure the package against opening took affect. This obligation is imposed by the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83 / EC of the European Parliament and of the Council by laying down detailed rules concerning safety features placed on the packaging of medicinal products for human use. The introduced novelties, combined with the database system collecting information on medicinal products from the territory of the European Union, are intended to prevent the presence of falsified medicinal products in the legal distribution chain.
What is medicines serialization?
One of the aims of the Counterfeit Directive is to create a European database system through which pharmacies, wholesalers and other entities supplying medicines to patients will verify the authenticity of medicinal products before dispensing them. Original prescription medications are serialized and entered into the European EU HUB system, where all serialized products are stored. Before dispensing the medicines to the patient, the pharmacist scans the code, verifies and deactivates it in the system using a special 2D Matrix code scanner. If the verification is positive - the pharmacist may issue such a medicament to the patient. However, if the code verification is negative, the system will notify it with an alert that this medicine may have been counterfeit. The pharmacist cannot give it to the patient and starts the procedure of re-checking the origin of the product.
What does the 2D Matrix code contain on medicines?
The code contains information about the batch number of the medicinal product, the serial number of the specific package, the product code and the expiry date of the product. So it is a unique code for each product packaging that cannot be repeated.
What to look for when buying medications?
The code given during product serialization is not the only security feature. What we should also pay attention to when buying drugs is a small sealing label, also known as ATD, or anti-tempering device. It is an additional protection against tampering with the drug packaging, so that it cannot be opened and, for example, its contents cannot be changed. Such a seal ensures the safety of the medicines, because when it is broken, it can be seen that the package has already been opened, that the label has been torn off, and even when it is re-affixed, we can see that the package has already been tampered with. It is worth emphasizing that we are talking only about prescription medication. This does not apply to dietary supplements and over-the-counter medications, the so-called OTC.
Who is responsible for the protection of medicines?
ATD sealing labels and assigning an identifier in the form of a 2D Matrix code are the responsibility of drug producer. Thanks to this, we have full identification of a medicinal product throughout the entire distribution chain, from the manufacturer to points of sale - medical wholesalers or pharmacies. However, if we buy medicines from suspicious sources, we are not sure whether it is the original product and what its composition is.
In the area of serialization, Prespack provides software that manages the production process and communicates data to the central repository of EU HUB serialization data. This software was developed with the purpose of serializing the packaging of Marketing Authorization Holders (MAH), but also Marketing Authorization Holders, for Parallel Import (PI MAH). Prespack has tested and implemented all serialization procedures with success and has successfully provided the service to all of its customers.
If you need more information about the Prespack serialization process, please contact us. We will answer all your questions.