Falsified Medicines Legislation

The European Union (EU) Falsified Medicines Directive amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introduces new rules to more rigorously regulate the supply chain. The main provisions of the Falsified Medicines Directive are: 

  • To introduce a new obligatory authenticity feature (referred to as a safety feature) which must appear on the outer packaging of designated medicines;

  • To introduce more robust rules regarding the control on starting materials and inspection of producers of active substances and excipients contained in medicines;

  • To introduce more robust controls on the wholesale distribution of medicines, including introducing controls for the first time on entities involved in brokering medicines;

  • To introduce a common, EU-wide logo to identify legal online pharmacies and to establish a notification system for entities offering to supply medicines to the public over the internet.

The falsified medicines legislative proposal was adopted by the Council and European Parliament in June 2011.

FMD 'use and learn' period ends in Ireland on 30 May 2022

The Falsified Medicines Directive (2011/62/EU) ‘(FMD’) introduced new requirements from February 2019 for safety features on prescription medicines packaging, enabling the packs to be authenticated as genuine prior to supply to patients.

FMD has been in a ‘use and learn’ phase in Ireland since February 2019 due, in part, to the impact of COVID-19 and Brexit. The use and learn phase ended for wholesalers on 9 May 2022 and for pharmacies and hospitals on 30 May 2022. After these dates, 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.

Detailed guidance has been developed for pharmacies, hospitals, wholesalers on what to do next if there is an alert and is available on the IMVO website.

For further information

IMVO

Queries re alerts: alert.support@imvo.ie

Queries re end-user registration/connection to the IMVS: registration@imvo.ie

Tel: +353 1 5715320

Website: www.imvo.ie

IMVO’s service desk opening hours – Mon-Fri 8-8; Sat 9-6; Sun/public holidays 11-6 

HPRA

Marketing authorisation holders and wholesalers can submit queries in respect of safety features to compliance@hpra.ie

Tel: +353 (1) 6764971

PSI

Queries: info@psi.ie

Website: https://www.thepsi.ie/gns/Pharmacy_Practice/FalsifiedMedicinesDirective.aspx

Tel: +353 1 2184000

HSE FMD Project Team

Queries re FMD: HSE.Support@ezfmd.com

Product recalls and FMD alert implications

MAHs and persons responsible for placing medicinal products on the Irish market are reminded not to decommission the unique identifiers on packs of batches in the event of a wholesale level recall of those batches in Ireland, and not to assign a recall status to those packs on the EMVS system during recalls to wholesale level. This is because decommissioning the unique identifiers and assigning a recalled status to those packs would result in alerts when pharmacies go to scan those packs during their dispensing operations.

Note that when recall actions are going to pharmacy and/or patient level in Ireland, the unique identifiers should be decommissioned, and a recalled status should be assigned to those batches.

European Commission Delegated Regulation for Safety Features on Medicinal Products for Human Use

The Commission Delegated Regulation (EU) 2016/161, that supplements Directive 2001/83/EC, with detailed rules for the safety features appearing on the packaging of medicinal products for human use, has now been adopted and was published in the Official Journal of the European Union on 9 February 2016.

The Delegated Regulation will apply in Ireland from 9 February 2019 (3 years after its publication).

The European Commission's Falsified Medicines webpage contains the link to text of the Delegated Regulation. 

The publication of the Delegated Regulation was accompanied by the publication of the following documents which can be accessed through the links provided below:

In addition the European Medicines Verification Organisation (EMVO) has asked competent authorities to communicate the following to manufacturers, importers and MAHs.

 

Irish Legislation

The following amendment Regulations concerning placing on the market, manufacture and wholesale of medicinal products have been signed by the Minister of Health and give effect to Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (also known as the Falsified Medicines Directive). 

  • Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. No. 162 of 2013)

  • Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 (S.I. No. 163 of 2013)

  • Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013
    (S.I. No. 164 of 2013)

The legislation concerning the application of fees by the HPRA has also been amended (see below) to include details of the fees which will be levied for the registration processes described in Directive 2011/62/EU.

Directive 2011/62/EC provides the basis of a number of implementation measures by the Commission. An overview is provided here.

The HPRA is working with a wide range of stakeholders, including the Department of Health, Customs and Excise, European Medicines Agency, European Commission and other national competent authorities on the implementation of the provisions contained within the new legislation.

Rules on importing active pharmaceutical ingredients into the European Union

The European Commission has published an information leaflet on the new rules on importing active pharmaceutical ingredients into the European Union.

 

Additional information