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, 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 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.

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 9February 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 9 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.

Click below for more information

Expand all

  • National approach to implementation from 9 February 2019

  • Phased Ending of FMD Use and Learn Period

  • What are the requirements for hospitals?

  • Where can I get further information?