Pharmaceutical marking is much more than just ‘text on a package’. It is the last safety net between the necessary administration of a highly effective medicine and the risk of incorrect use or confusion.
This is precisely why national and European regulations stipulate precisely what must be stated on packaging, how it must be designed – and how each individual package can be clearly identified.
In practice, the marking acts as a two-stage protection system: firstly, it ensures that patients, pharmacies, clinics and specialist staff can clearly identify a product and use it correctly. Secondly, it protects the supply chain by making counterfeiting more difficult and speeding up recalls.
Standardised dosage forms such as blister packs (push-through packs) in particular demonstrate how strict the requirements are: essential information must be permanently, clearly legible and unambiguously displayed in a confined space. This is not an end in itself, but a consequence of the everyday risks associated with modern pharmaceutical supply. These risks include mix-ups, incorrect dosages, parallel imports, repackaging, logistics across multiple countries – and, unfortunately, attempts to smuggle counterfeit products into legal distribution channels.
In addition to traditional marking requirements, the EU has therefore also established security features and serialisation, which must be implemented on a mandatory basis in most areas from February 2019 onwards.
What must be included on blister packs
For medicinal products for human use, EU law specifies the information that must appear on the outer packaging (or, if there is no outer packaging, on the primary packaging). This includes the name of the medicinal product, strength, dosage form and, depending on the product, the INN/active ingredient. Information such as the batch number and expiry date, as well as a note that the product is only available from pharmacies and the marketing authorisation number, are also required.
In Germany, this is regulated very specifically in the Medicines Act (AMG) – including special requirements for blister packs. Section 10 AMG makes it clear that marking is not a ‘nice to have’ but a mandatory component of marketability. The following applies to blister packs: even if space is limited, key identification information must be reliably available on the blister itself – so that individual cavities do not become ‘anonymous’ once the outer packaging is removed. Because ‘legibility’ must not be a matter of interpretation, guidelines and QRD specifications supplement the legal requirements and define clear rules for design and comprehensibility.
With the Falsified Medicines Directive (FMD), Europe has added a digital security layer to marking. Since February 2019, many prescription medicines have carried a 2D data matrix code with a unique identifier and tamper-proofing. The code contains the serial number and other identifiers such as the product code, batch and expiry date, and is verified upon dispensing. This means that counterfeits and recalls can be identified in seconds – not in the laboratory, but directly in the process.
For manufacturers, this is more than just an IT project: print quality, legibility, inline verification, clean data handling and stable interfaces to serialisation and ERP systems are an integral part of regulatory compliance.
Bottom line: Marking is not a compulsory exercise, but rather a systematic risk mitigation measure – physically (plain text), organisationally (specifications & legibility) and digitally (serialisation & verification). Those who consistently combine these levels achieve exactly what counts in the pharmaceutical world – trust down to the last tablet.
You will find the right tools for marking cardboard boxes and blister packs here. Röltgen also offers blister punching and regrinding services.
