Guidance

Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports

Published 5 April 2024

Applies to England, Scotland and Wales

1. Disapplication of FMD safety features and encoding of pack information under UK law

From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. EU FMD safety features will therefore not apply to parallel import licences.  PLPI licence holders must still ensure packs are decommissioned correctly and cannot re-enter the EU supply chain. Any 2D barcode encoding an alphanumeric character sequence (as referred to in EU Regulation 2016/161) that has been uploaded to the European repositories system should be fully removed or covered.  Packs must comply with the requirements in section 6 of the Windsor Framework guidance on labelling and packaging requirements.

A separate variation is not required to remove the FMD label details from PLPI artwork.

2. Decommissioning of imported packs

Since 1 January 2022, packs have been decommissioned on export from the EU. See Commission Notice 2021/C 27/08.

 PLPI products that are re-packed in the UK must be decommissioned either during the re-packing process or before being exported to the UK.

PLPI products that are re-packed within the EEA, must be decommissioned prior to the re-packing process and export to the UK.

From 1 January 2025, PLPI licence holders must ensure imported packs are decommissioned correctly and cannot re-enter the European supply chain.

3. Guidance on checking Italian and Greek FMD compliant stock

There are two countries (Italy and Greece) that are yet to implement the 2D barcode UI system. Italian and Greek products are exempt from the Falsified Medicines Directive requirement to carry an FMD Unique Identifier for verification of the authenticity of the pack. This is because Italy and Greece already have a verification system in place. Their systems make use of a two-part label in which the top part can be removed for reimbursement purposes.

Where the 2D barcode UI is not in use it is the responsibility of the licence holder importing the product into the UK to identify falsified, stolen or recalled stock, including those that have already been decommissioned.

3.1 Italian stock

The Italian Medicines Agency (AIFA) have issued updated guidance on the security label used by Italy, the ‘bollino’.

This system uses a serial number on a 2-layered adhesive sticker/label which can be tracked via a central database and must be applied to each pack. The upper label is removed upon dispensing in Italy leaving a voided area and strip containing the repeated serial number.

The complete Italian bollino label (2 layers) must be present on the outer carton of packs exported from Italy. Furthermore, the exported packs should bear a nullification mark (e.g., an “ESPORTAZIONE” stamp or a cross over the barcode).

The MHRA have been made aware of packs that do not have the full 2 layers of the bollino label or packs on which the bollino has been falsified and is not of the correct appearance. AIFA state that both a missing bollino or products bearing a falsified bollino should be considered as a falsified medicine and reported.

If there are anomalies with missing bollino or bollino labels showing different features from those described in the guidance document, please contact medicrime@aifa.gov.it, who will check the legitimacy of the products.

Legitimacy of labels can also be checked using the Italian Ministry of Health’s drug package verification website.

Italian Medicine Agency guidance (PDF, 3.61MB, 2 pages)

3.2 Greek stock

Greece operates a similar, two-layer system where the unique identifier (pack serial number) is placed upon an authenticity sticker carrying a linear GS1 128 serialised barcode plus an EAN 13 product barcode. The labels fluoresce under UV light and have holograms of varying designs embedded within them. As with the Italian system, the adhesive top layer sticker would be removed when the product is dispensed in Greece to reveal an exposed area where it was once located.

Example of a Greek FMD barcode.

These barcodes are decommissioned in the Greek system upon dispensing or export. The Greek National Organisation for Medicines (EOF) has also developed and disseminated through its website a software application which can be used for tracing individual product packs.

The link below can be used to check if specific stickers are valid and correspond to the physical medicinal products that they are affixed to:

Authenticity label check

4. Reporting suspected falsified medicines

Any falsified medicines identified should be reported through the Yellow Card reporting system [Report a FAKE or Counterfeit]. For FMD applicable Prescription only Medicines (POM) products containing the Unique Identifier (UI) 2D bar code the following information is needed: A report of an alert for one of these packs should include:

• the alert number in the following format: “GB-xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx” and the following details from the pack itself:
• GTIN
• serial number
• batch id
• expiry date

Ideally this would be with images of the pack showing all 4 elements in human readable format AND the 2D barcode. The alert could be generated for any of the following codes upon verification or decommissioning:

• NMVS_FE_LOT_03
• NMVS_FE_LOT_12
• NMVS_FE_LOT_13
• NMVS_NC_PC_01
• NMVS_NC_PC_02
• NMVS_NC_PCK_19
• NMVS_NC_PCK_22

For FMD applicable products without a Unique Identifier (UI) 2D bar code from Italy or Greece the following is needed:

• supplier details
• product particulars
• photographs (to include the side where the adhesive stickers / labels should have been present
• date received

5. Further information

Please send any general enquires in relation to FMD Safety Features to: FMD.GMPenquiries@MHRA.gov.uk. Do not use this email address to report suspected falsification – refer instead to the Yellow Card reporting system.

See further guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework.