Falsified Medicines Directive: Medicines Authentication – Frequently Asked Questions

The EU has introduced additional measures across Europe designed to protect the medicines supply chain against the risk of falsified (or counterfeit) medicines.

Please find below further information on these requirements and the implications for pharmacists and pharmacies:

What is the Falsified Medicines Directive?

In 2011, the European (EU) Commission published a new directive, 2011/62/EU, which is known as the Falsified Medicines Directive. This Directive amends EU Directive 2001/83/EC on Human Medicinal Products and introduced new measures to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines.

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 a number of documents including a Q&A document from the EU Commission.

The Delegated Regulations on Safety Features comes into effect across Europe from the 9th February 2019.

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

When are medicines required to have safety features?

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

Packs without safety features already on the market before 9th February 2019 may continue to be supplied by pharmacists until their expiry date, unless recalled before then.

Initially many products in pharmacies and hospitals will not have safety features on the packaging. The number of products with safety features on the packaging will increase over time as medicines come through the supply chain.

What are the implications for Pharmacists and Pharmacies?

According to 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.

From 9th February 2019, if a medicinal product package has safety features on it:

  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 be registered with the Irish Medicines Verification Organisation (IMVO) and connected to the Irish Medicines Verification System (IMVS).

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 9th February

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

This approach aims to ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.

The agreed approach is:

  • All medicinal products released by the pharmaceutical companies for the Irish Market after 9th 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 should be registered with IMVO and connected 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 should 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 (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.

See also this communication to pharmacists issued on 5th February.

What are the requirements for hospitals?

Under the EU directive, hospitals are considered “Healthcare Institutions” and are required to verify the safety features on medicinal products. The Directive provides for healthcare institutions to scan and decommission products at an earlier point to assist with local logistical arrangements. The HSE is leading centrally on the introduction of the Falsified Medicines Directive in public hospitals. The HSE has a central contact point and ask anyone affected by FMD to send your questions / concerns to: FMD.support@hse.ie. The Private Hospitals Association has also been working with the Department of Health stakeholder group to prepare the private hospitals for introduction of FMD: info@privatehospitals.ie.

Where can I get further information?

Irish Medicines Verification Organisation (IMVO)
The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland and the vast majority of pharmacies, wholesalers, MAH’s and manufacturers have registered with the IMVO. IMVO have contacted all pharmacies with details of how to register with the IMVO and connect to the national repository system. Further information 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.

Health Products Regulatory Authority (HPRA)
The HPRA website has information and updates about the Falsified Medicines Directive, relevant to its stakeholders.

The Irish Pharmacy Union (IPU)
The IPU continues to assist its members in getting ready for the 9 February deadline and has published articles, reports and frequently asked questions providing more information on the Falsified Medicines Directive on its website (IPU Member access).

Health Service Executive
For pharmacies in public hospitals and clinics, the HSE has established a project team to co-ordinate the Falsified Medicines Directive implementation across the health services, and will be managing communications within the HSE. The HSE's October Newsletter contains useful updates on their preparations for the Falsified Medicines Directive. If you have any questions on the Falsified Medicines Directive implementation in the health services, please email FMD.support@hse.ie.