Falsified Medicines Directive: Medicines Authentication

FMD Latest Information (16 May 2022):

Phase 6 of ‘use and learn’ commenced on 9 May. This means all alerts generated by wholesalers must be investigated, and suspected falsification ruled out, before the relevant packs may be returned to saleable stock or supplied. The ‘use and learn’ period will end on 30 May for all pharmacies and hospitals. All alerts generated by pharmacies and hospitals must be investigated, and suspected falsification ruled out, before the relevant packs may be supplied.

The data from the Irish Medicines Verification System shows that the current decommissioning rate in Ireland is low and inconsistent by comparison with other EU States. We ask all pharmacists to ensure that they scan and decommission each medicine that they dispense. Support or help needed is available from the IMVO or your software provider to ensure to can meet these obligations.  

The PSI is contacting superintendent pharmacists directly about their current compliance levels. In the interests of patients, we have directed all superintendent pharmacists to review the practices in their pharmacies in relation to FMD to ensure full and consistent compliance with the requirements of this safety legislation.

It remains the responsibility of pharmacy owners and superintendent pharmacists to ensure that the legal requirements of FMD are being met within their pharmacies to ensure the continuity of safe supply of medicines to patients.

Falsified Medicines Directive and national implementation

In 2011, the European Commission published a new directive, 2011/62/EU, known as the Falsified Medicines Directive which amends EU Directive 2001/83/EC on Human Medicinal Products.  The purpose of this Directive is to introduce a coordinated and IT-enabled system of measures across Europe designed to protect the medicines supply chain against the risk of falsified (or counterfeit) medicines. These measures are intended to enhance patient safety by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and by introducing new rules to, more rigorously, regulate the supply chain.

The Commission Delegated Regulation (EU) 2016/161 (‘Delegated Regulation’) was published by the Commission in February 2016. This legislation sets out detailed rules for the safety features appearing on the packaging of medicinal products for human use. It supplements the Directive and sets out exactly what manufacturers, wholesalers and persons authorised to supply medicines to the public need to do to ensure that the medicines supplied to patients are authentic.

The publication of the Delegated Regulation was accompanied by the publication of documents including a Q&A document from the EU Commission.

The Delegated Regulations on Safety Features came into effect across Europe on 9 February 2019. Irish legislation giving effect to Commission Delegated Regulation (EU) 2016/161 commenced on 8 February 2019.

You can review PSI communications to pharmacists on FMD:  

What are the Safety Features?

The Delegated Regulations require all EU pharma companies (originator companies, generic companies and parallel distributors) to place ‘safety features’ on the packaging of medicinal products which consist of:

  1. An anti-tamper device so the person supplying it can be sure it hasn’t been interfered with. (Such devices are already common on many medicines but will be mandatory for most medicines in future).
  2. A special 2D barcode containing information about the medicine, known as unique identifiers. Embedded in this barcode will be a product code, serial number, batch number and expiry.
Tamper proof seal and 2D barcode

The Delegated Regulation set an implementation deadline of 9 February 2019 and manufacturers must ensure medicines released to the Irish market after this date have the required safety features.

What are the implications for Pharmacists and Pharmacies?

Under the Delegated Regulation ‘a person authorised or entitled to supply medicines to the public’ must verify the safety features on the packaging of medicinal products upon supply of the medicines.

Therefore, all pharmacists and pharmacies must ensure that the following actions are taken for all medicines supplied to patients: 

  1. the unique identifier, contained in the 2D barcode, must be authenticated by scanning and decommissioning; and
  2. the anti-tamper device must be checked to ensure that it is intact.

To be able to scan and decommission the 2D barcode on a pack, pharmacies must have a scanner with associated software in place and be registered with the Irish Medicines Verification Organisation (IMVO) and connected to the Irish Medicines Verification System (IMVS).

The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland. All pharmacies, wholesalers, MAH’s and manufacturers are required to register with the IMVO.

IMVO has produced guidance for pharmacists on the implementation of FMD requirements which is available on the IMVO website, including details of introductory webinars for pharmacists. IMVO has also made the webinars available for download and has provided additional guidance to pharmacists on where to go for support, and has sent out guidance on scanning to all pharmacies. This includes a video on how to scan correctly as well as details of how to check that your scanner is configured correctly and if not, how to fix it.

Any pharmacy not registered with IMVO should contact IMVO as a priority to complete registration and connect to the IMVS.

National approach to implementation from 9 February 2019

Following discussions at a national and European level with all stakeholders, all stakeholders involved decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the ‘go live’ date of 9 February 2019. 

The purpose of this has been to ensure the continuity of safe supply of medicines to patients while all parties in the supply chain implemented the relevant requirements and gained a better understanding of how the new system works and how to incorporate the requirements within their own business processes. 

The agreed approach is: 

  • All medicinal products released by the pharmaceutical companies for the Irish Market after 9 February will bear the safety features as required i.e. a tamper proof seal and 2D barcode. 
  • All stakeholders (manufacturers, wholesalers, pharmacies and hospitals) involved must register with IMVO and connect to the IMVS (repository), as required. 
  • During the initial period of operation, the system will be considered to be in ‘use and learn’ phase including alert management. Pharmacies must scan medicines bearing the safety features. If an alert or any other unexpected message is flagged pharmacies should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved. 
  • All alerts generated by your FMD system upon scanning a pack during this ‘use and learn’ phase will be forwarded by the system to the IMVO, the HPRA and the pharmaceutical companies so that they can be investigated and monitored. 

Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA and not supply the pack. The HPRA can be contacted by email to qualitydefects@hpra.ie or using the HPRA’s online reporting system (select the online form 'Medicine Quality Issue/Defect').

While the system is currently in a 'use and learn' phase, the PSI reminds pharmacists that they are legally required by this EU legislation to verify the safety features on the packaging of medicinal products and decommission the product

from the IMVO repository by scanning the relevant barcode and checking the anti-tamper device before they are supplied to patients. Pharmacists’ full co-operation and participation in scanning and decommissioning of all relevant products, and checking anti-tamper devices is extremely important to enable the full and effective implementation of the national system and also to allow pharmacists time to incorporate this new additional safety measure into the dispensing process in your pharmacy. 

Ireland is now moving to full implementation of our obligations under the Directive and the phased end of the ‘use and learn’ period is planned over the next months, with full implementation to take effect from 30 May 2022. This table outlines the phased approach to May 2022. 

Click below for more information

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  • What prerequisites must be met to end 'use and learn'?

  • What are the requirements for hospitals?

  • Where can I get further information?