Pharmaceutical labels are not simply stickers affixed to products, but genuine information and safety tools for healthcare professionals and patients. As well as complying with strict regulations, they must ensure clear and effective communication, thereby contributing to the proper use of medicines.
In this article, we take a detailed look at the mandatory requirements for pharmaceutical labels, the technical specifications that must be met and the innovative solutions that improve product safety and traceability.
Contents
Introduction: the role of pharmaceutical labels
Mandatory information on drug labels
Types of label for the pharmaceutical sector
Marking and serialisation of medicines
Technical and safety requirements for pharmaceutical labels
Conclusions
1. Introduction: the role of pharmaceutical labels
Drug labels not only identify the product, they are also of vital importance to patient safety and regulatory compliance. Drug labelling plays a crucial role in the pharmaceutical industry, ensuring that product information is clear, legible and compliant with safety and traceability standards. As well as providing essential information to patients and healthcare professionals, pharmaceutical labels must meet strict technical and regulatory requirements to ensure safe use and protection against counterfeiting.
In this article, we will look in detail at the mandatory information that must appear on drug labels, the different types of labels used in the industry, the marking and serialisation process and the technical requirements needed to ensure reliable and secure labels.
2. Mandatory information on drug labels
Under current legislation, all medicines must be labelled with the following essential information:
Name of the medicinal product
Name of the medicinal product, including its international non-proprietary name (INN) where applicable.
Trade name of the product (if applicable).
Pharmaceutical form and strength
Tablets, capsules, oral solution, injectable solution, etc.
Quantity of active ingredient per unit dose (e.g. 500 mg per tablet).
List of excipients
Specification of all ingredients, with particular attention to those which may cause allergic reactions.
Route of administration
Clear indication of the method of administration of the medicinal product (oral, topical, injectable, etc.).
Warnings and precautions for use
Specific information on possible side effects or associated risks.
Warning symbols for prescription or high-risk medicines.
Batch number and expiry date
Essential for product traceability and safety.
Must be clearly visible and printed with resistant inks.
Storage conditions
Information on the ideal temperature and humidity to guarantee the stability of the medicinal product.
Unique identification code (Data Matrix or barcode)
Used for serialisation and traceability of the drug throughout the distribution chain.
3. Medicines labelling: types of label for the pharmaceutical sector
Depending on the use and type of medicine, there are different labelling solutions:
Types of labels | Characteristics |
Self-adhesive labels | Easy to apply, it is ideal for bottles, blisters and cans. They must be resistant to moisture and solvents. |
Booklet labels (multi-page) | Perfect for medicines with a lot of information to enter or for multiple languages. |
Labels resistant to low temperatures | Used for medicines stored at very low temperatures, such as vaccines, which must be resistant to humidity. |
Tamper-evident labels | With security systems to ensure product integrity to prevent counterfeiting and guarantee the authenticity of the medicine. |
4. Marking and serialisation of medicines
The serialisation of medicines is an essential measure in the fight against counterfeiting and to ensure product traceability. This process is based on the application of unique identification codes to each pack of medicine.
Serialization process
Allocation of a unique code
Each parcel receives an identification code that complies with international standards (e.g. GS1 Data Matrix).
Printing and verification
The code is printed directly onto the label using inkjet or laser technology.
Optical verification systems ensure that the code is legible and accurate.
Database entry
The code is uploaded to a central database for tracking throughout the supply chain.
Traceability and verification by healthcare professionals
Pharmacists and healthcare professionals can scan the code to verify product authenticity and traceability.
5. Technical and safety requirements for pharmaceutical labels
Pharmaceutical labels must meet strict technical requirements to guarantee safety, legibility and durability. Here are a few key aspects:
Materials and adhesives
They must be resistant to the environmental conditions typical of pharmaceutical storage (humidity, temperature, chemical solvents).
The adhesive must guarantee perfect adhesion to the surface of the container without the risk of unintentional peeling.
Printing technologies
Digital printing for advanced personalisation and high resolution.
Hot stamping or screen printing to add security features such as holograms.
Security and anti-counterfeiting
UV-reactive or thermochromic inks.
6. Conclusion
Pharmaceutical labelling is not just a question of compliance, but an essential element in guaranteeing the safety, traceability and reliability of medicines.
Thanks to our experience in this field, we are able to provide pharmaceutical labels that comply with current regulations, with tailor-made solutions for every need.
If you would like to know how to improve the labelling of your pharmaceutical products, contact us for a personalised consultation.
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