Falsified Medicines Directive: Medicines Authentication

FMD Latest Information (21 June 2022):

The 'use and 'learn' period for the Falsified Medicines Directive (FMD) in Ireland is ended as of Monday, 30 May 2022. 

S.I. No. 270 of Medicinal products (safety features on packaging) Regulations 2022 was signed into legislation by the Minister of Health on 1 June 2022. This legislation makes verification and decommission of medicinal products a legal requirement. The Department of Health and the PSI are consulting on improving FMD compliance in pharmacies and are drafting legislation to invoke regulatory enforcement measures.

The Falsified Medicines Directive (2011/62/EU) is a patient safety initiative that introduced new requirements to prevent falsified medicines from entering the medicines supply chain. From February 2019 safety features have been required on prescription medicines packaging, enabling the packs to be authenticated as genuine prior to supply to patients. 

Pharmacies, hospitals and wholesalers may not supply packs that generate alerts when scanned unless the alert has been fully investigated and a root cause has been found and falsification ruled out. It is 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.

The PSI is monitoring the performance of pharmacies and we will continue to engage, explain and encourage compliance with this legislation. We will engage directly with pharmacies and pharmacists where there is a concern as to their compliance.

Detailed guidance and ongoing support is available to pharmacies from the Irish Medicines Verification Organisation (IMVO), including what to do if there is an alert to be dealt with. The Irish Institute of Pharmacy and IMVO have recordings of webinars they have hosted and these may also be helpful. Communications from the PSI to pharmacists and pharmacies about their roles and responsibilities in line with this legislation are available below.


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. A pragmatic, phased approach to the implementation of the legislation was taken with a 'use and learn' phase from February 2019 to May 2022. 

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 must pharmacists and pharmacies do?

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.

All pharmacists and pharmacies have a legal obligation to check the safety features on the packaging of medicines and ensure that the following actions are taken before supply to patients: 

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

Following the initial phased introduction of the legislation ('use and learn'), from Monday, 30 May 2022 packs cannot be supplied until the root cause of an alert has been established and falsification ruled out. Pharmacists must provide support for alert investigations, in particular, identifying if there is a root cause within the pharmacy. 

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, MAHs 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.

Depending on your requirements, support is available from the IMVO, or by contacting your pharmacy's FMD software provider.

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’s online reporting system (select the online form 'Medicine Quality Issue/Defect') should be used or email qualitydefects@hpra.ie.

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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?