Strictly regulated labels on medicine packages combat falsified medicines

Many of the labels are intended for healthcare professionals. These are used to help combat falsified medicines. Only a few labels in addition to the mandatory ones can be displayed on the outer and inner packaging of medicinal products.

Medicine users will find the information required for the safe and correct use of the medicine on the package. However, some of the labels are intended for professional use.

Why do medicine packages have strange numbers and abbreviations on?

The number sequences and abbreviations of letters are essential, as they enable all the professionals handling the medicine, such as pharmacists, to identify the medicine.

When you pick up a prescription medicine prescribed to you by your doctor, the pharmacist first scans the 2D-code on the outer packaging of the medicine. It contains a large amount of information.

The pharmacist will also check the Nordic product number series, the Vnr. The Vnr is a six-digit code used to identify a single medicine package at all stages of its distribution.
 

How does traceability labelling combat falsified medicines? 

The number sequences and individual serial numbers are used to prevent falsified medicines from ending up on the market among legal medicines. This certificate method is called serialisation

In serialisation, each legal medicinal product is saved in the EU pharmaceutical database. When a medicine goes from the factory through the wholesaler to the pharmacy and from there to the patient, the professional handling the package at each stage ensures that the medicine is exactly what the package codes say it is. 

In Finland, falsified medicines are not a problem, but they have been found at many foreign pharmacies. Falsified products are skilfully manufactured, and without an EU-level system of serialisation, a much larger number of falsified medicines would end up in public use. 

If you want to avoid falsified medicines, do not buy medicines from foreign pharmacies and do not order them from foreign online shops – even websites that look like genuine internet pharmacies. You may receive a product containing a completely different substance than the one you ordered. In the worst case, you may end up with a product that poses a risk to your health.

Who can you contact if you suspect that you have purchased a falsified medicine product? 

If you suspect that the medicinal product you have bought is falsified, please contact the Finnish Medicines Agency Fimea. You can report suspected falsified products via the Internet, for example.
 

What labelling other than that required by the authorities may be included on medicinal packages? 

Package labelling may also contain the same information that is provided on the summary of product characteristics (SPC) and package leaflet. The difference between the two is the target audience: the SPC is intended for healthcare professionals while the package leaflet is for consumers. The package leaflet can be found inside the medicine package. 

In practice, there is very little space to fit any additional information on the package labelling. However, if there is space, mandatory labelling can be supplemented, particularly for self-care products, with more specific dosage guidelines. 

It is permitted, although not mandatory, to mention on the outer package labelling the user group of the medicinal product, for example that the product is intended for children. 

Additional labelling mainly concerns nutritional supplements which are not medicinal products. This often includes whether the product is sugar-free, lactose-free or gluten-free. One example of additional labelling is that when Orion celebrated its 100th anniversary in 2017, the packaging of many of Orion’s nutritional supplements and cosmetic products displayed Orion’s centenary logo. 

Is there a difference in the requirements for the outer and inner packaging?  

The outer packaging and the inner packaging, which is directly in contact with the medicinal product, are mainly subject to the same labelling requirements. One exception is braille, as information printed in braille is mandatory on the outer packaging only. If the medicinal product is sold without outer packaging or protective casing, the mandatory information must be provided in braille on the product’s packaging. 

The inner packaging may, in some cases, display less comprehensive labelling than that required on outer packaging. This type of less comprehensive labelling can be seen on blister packs of tablets or capsules, for example. At minimum, the packaging must provide the trade name, the name of the active pharmaceutical ingredient, the strength and pharmaceutical form of the medicinal product, the name of the marketing authorisation holder and the expiry date and the batch number of the medicinal product.

 

The expert interviewed was Pernilla Holmqvist, Development Manager and Team Leader at Orion Pharma.

Text: Essi Kähkönen

24 January 2022

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