Icelandic Medicines Agency
Safety features of medicinal products
Safety features on the packaging of medicines for human use are intended to prevent falsified medicines from entering the legitimate supply chain. They allow an individual pack to be identified, its authenticity to be verified and any tampering with its packaging to be detected.
There are two types of safety feature:
A unique identifier, which allows an individual pack to be identified and its authenticity verified.
An anti-tampering device, which indicates whether the packaging has been tampered with.
Safety features must appear on the outer packaging of the medicine or, where there is no outer packaging, on the immediate packaging.
Which medicines must bear safety features?
Prescription medicines for human use must generally bear safety features. The medicines and categories of medicines listed in Annex I to Regulation (EU) 2016/161 are exempt.
Non-prescription medicines generally do not bear a unique identifier. However, certain non-prescription medicines listed in Annex II to Regulation (EU) 2016/161 must bear safety features.
The Icelandic Medicines Agency does not grant exemptions from the requirements for safety features for medicines that must bear them under the applicable rules.
Exempt medicines
The requirements for safety features generally apply to medicines that have a marketing authorisation and fall within the scope of the rules on safety features. These requirements therefore do not apply in the same way to exempt medicines.
However, a pack of an exempt medicine may bear safety features, for example where the medicine is authorised and subject to prescription in the EEA country for which the pack was originally intended. Such a pack can be verified and decommissioned through the European Medicines Verification System (EMVS).
If the unique identifier on a pack of an exempt medicine has already been decommissioned, an exemption must be requested for the pack to be released onto the Icelandic market.
Exempt medicines from the UK and other countries outside the EEA
The United Kingdom is not part of the European Medicines Verification System. However, packs from the UK may bear a two-dimensional barcode even though information about the pack is not available in the European Medicines Verification System.
The same may apply to exempt medicines from other countries outside the EEA that bear a two-dimensional barcode. Scanning these packs may therefore produce error messages or indicate that the product code, batch number or serial number is not recognised by the system.
If the pack information cannot be verified, check whether the packaging shows any signs of tampering, whether the medicine has expired and whether the anti-tampering device is intact and undamaged.
If there is any suspicion that the pack has been tampered with or that the medicine is falsified, it must not be dispensed. The matter must be reported to the Icelandic Medicines Agency in accordance with its guidance on defective and falsified medicines.
Known issues with packs from outside the EEA
Scanning packs from the UK
When packs from the UK are scanned, the response from the medicines verification system may vary depending on the information encoded in the two-dimensional barcode and whether that information is recognised by the European Medicines Verification System.
A new product code that the system does not recognise
If a pack bears a product code (PC) that the European Medicines Verification System does not recognise, the message “Unknown product code” is displayed. The system code is 41020000 and the alert code is #A1. No alert is logged. The same response may occur when scanning exempt medicines from countries outside the EEA.
The product code is recognised, but the batch number or serial number is not
If the pack’s product code is recognised by the European Medicines Verification System but the batch or serial number cannot be found, the message “Unknown serial number. Batch not found.” may be displayed. In this case, an alert is logged. The system code is 41020002 and the alert code is #A2.
The serial number is missing from the two-dimensional barcode
If the two-dimensional barcode does not contain a serial number, scanning the pack produces a message indicating that a serial number is required. The system code is 41020000 and no alert is logged.
Pack information recorded only in the UK system
If the pack information was recorded only in the UK medicines verification system, a message may indicate that the product code or batch is unknown, or that an error occurred when communicating with another country’s system. The system code is B1020001, the EMVS error code is #A22 and no alert is logged.
Further information can be requested through the Contact us function on the Icelandic Medicines Agency’s website.
Unique identifier and two-dimensional barcode
The unique identifier must be encoded in a two-dimensional Data Matrix barcode on the medicine’s packaging.
The unique identifier must contain:
A product code that identifies the medicine
A serial number unique to the individual pack
The batch number
The expiry date
A national reimbursement or identification number, where applicable
The product code and serial number must also appear on the packaging in human-readable format. This requirement does not apply where the sum of the two longest dimensions of the packaging is 10 cm or less. Where the size of the packaging permits, this information must be placed as close as possible to the two-dimensional barcode.
The product code and serial number must appear on the same side of the packaging. Wherever possible, the batch number and expiry date must also appear on the same side or as close to this information as possible.
Appropriate abbreviations, such as PC, SN, Lot and EXP, may be used to identify the information, provided their meaning is clear and unambiguous.
A two-dimensional barcode on a medicine’s packaging does not automatically constitute a safety feature. The information encoded in the barcode determines whether it constitutes a unique identifier under the rules on safety features.
The medicines verification system
Unique identifiers on medicine packs are verified through the medicines verification system, which forms part of the European system for verifying medicines.
Lyfjaauðkenni ehf. operates the Icelandic medicines verification system. Companies and other parties that need to connect to the system must contact Lyfjaauðkenni regarding technical integration, access and use of the system.
Anti-tampering device
An anti-tampering device indicates whether a medicine’s packaging has been tampered with. It must therefore be designed so that any opening of or tampering with the packaging can be detected.
The standard ÍST EN 16679, Packaging – Tamper verification features for medicinal product packaging, may be used as a reference when designing an anti-tampering device.
Responsibilities of marketing authorisation holders
Marketing authorisation holders are responsible for ensuring that medicines covered by their authorisations comply with the applicable requirements for safety features.
The requirements for safety features apply in addition to other requirements for the packaging and labelling of medicines. Marketing authorisation holders therefore remain responsible for ensuring compliance with all applicable requirements for the immediate packaging, outer packaging and package leaflet.
The requirements for safety features do not change the language requirements for information on the immediate or outer packaging or in the package leaflet.
Repackaging and replacement of safety features
When a medicine bearing safety features is repackaged or relabelled, continued compliance with the requirements for safety features must be ensured.
If a safety feature has been removed or covered, the authenticity of the medicine and the integrity of its packaging must be verified before the feature is replaced. The replacement safety feature must comply with the applicable requirements and allow verification that the medicine is authentic and that its packaging has not been tampered with.
Repackaging and relabelling must also comply with other applicable requirements concerning manufacturing, marketing authorisations, labelling and distribution.
Verification and decommissioning of unique identifiers
Those supplying medicines bearing safety features to the public must verify the safety features and decommission the pack’s unique identifier in the medicines verification system.
Pharmacies
Pharmacies must be connected to the medicines verification system. When supplying a medicine bearing safety features, they must verify the safety features and decommission the pack’s unique identifier.
Healthcare institutions
Healthcare institutions must have access to the medicines verification system. They may verify the safety features and decommission the unique identifier after the medicine comes into their possession and before it is supplied to the public, provided the conditions set out in the applicable rules are met.
Verification and decommissioning by wholesalers
Wholesalers must verify the safety features and decommission the unique identifiers of medicines before supplying them to certain parties authorised to purchase medicines wholesale.
This applies to supplies to:
Doctors and dentists purchasing medicines for professional use
Veterinarians purchasing medicines for professional use and for sale through veterinary dispensaries
Universities and other research institutions conducting research on medicines
Residential and nursing homes that are not operated by a healthcare institution
The Directorate of Health purchasing routine vaccines and influenza vaccines
The wholesaler must ensure that the safety features have been verified and the unique identifier decommissioned before supplying the medicine to the parties listed above.
When only part of a pack is supplied
When only part of a pack is supplied and its unique identifier has not already been decommissioned, the safety features must be verified and the unique identifier decommissioned when the pack is first opened.
When the medicines verification system is unavailable
If technical problems prevent verification and decommissioning of the unique identifier, the identifier must be recorded and the anti-tampering device checked to ensure it is intact before the medicine is supplied.
The pack must be verified and its unique identifier decommissioned in the medicines verification system as soon as the technical problems have been resolved and the system is available again.
Reactivating a unique identifier
A decommissioned unique identifier may be restored to active status only if all the following conditions are met:
The change is made by a person covered by the same authorisation or entitlement and operating at the same premises as the person who decommissioned the identifier.
The change is made within ten days of decommissioning.
The medicine has not expired.
The pack has not been recorded as recalled, withdrawn, intended for destruction or stolen, and the person making the change is not aware that the pack has been stolen.
The medicine has not been supplied to the public.
If the unique identifier cannot be restored to active status because these conditions are not met, the medicine must not be returned to saleable stock.
Suspected falsification or tampering
If there is reason to believe that a medicine’s packaging has been tampered with, or verification of the safety features indicates that the pack is not authentic, the medicine must not be supplied.
Suspected falsified medicines must be reported to the Icelandic Medicines Agency without delay. Further information on reporting defective and falsified medicines is available on the Icelandic Medicines Agency’s page.
Further information
Safety features on the packaging of medicines for human use are governed primarily by 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 for the safety features appearing on the packaging of medicinal products for human use; Regulation No. 140/2019 on safety features appearing on the packaging of medicinal products for human use, as amended; the Medicinal Products Act No. 100/2020; and Regulation No. 545/2018 on marketing authorisations for proprietary medicinal products, their labelling and package leaflets, as amended.
The European Commission’s guidance, Safety features for medicinal products for human use – Questions and Answers, is also taken into account.
Links to further information
European Commission information on falsified medicines (ec.europa.eu)
European Commission questions and answers on safety features (Version 11, November 2018) (ec.europa.eu)
Icelandic Medicines Verification Organisation (ICEMVO) (lyfjaaudkenni.is)
Letter from EMA, CMDh and HMA to stakeholders on the implementation of the medicines verification system, 9 February 2019 (hma.eu)