Falsified Medicines Directive
The EU passed the Falsified Medicines Directive in 2011 to prevent falsified medicines infiltrating the legal supply chain and reaching European patients.
The directive requires medicine packs to carry special safety features.
These are:
- an anti-tamper device (e.g. foil seal, breakable cap)
- a barcode containing ‘unique identifiers’ (includes serial number) - the authenticity of the pack can be checked prior to dispensing.
This has been given effect in Irish law by S.I. No. 36/2019 - Medicinal Products (Safety Features On Packaging) Regulations 2019.
Requirements for hospitals
All medicines which fall under FMD and are supplied to patients must be checked for authenticity. This is achieved by checking that the anti-tamper device is intact and scanning the 2D FMD barcode. The data encoded in the barcode is checked versus the European database of medicines for authenticity and decommissioned from the European supply chain.
Hospitals with dedicated pharmacies and/or blood transfusion laboratories are classified as ‘Healthcare Institutions”. They must perform anti-tamper device checks and scanning of 2D FMD barcodes.
The Directive requires scanning to be performed as close to supply to the patient as possible. However, healthcare institutions can scan and decommission medicinal products on a ‘goods inwards’ basis at the time of delivery to overcome logistical issues. All affected HSE and HSE-funded healthcare institutions have been supplied with hardware and software to facilitate scanning on this basis.
Article 23 Sites
Certain sites without a dedicated pharmacy can avail of a derogation under Article 23 of the Delegated Regulation. Wholesalers are obliged to perform decommissioning on behalf of these sites.
A list of sites which can avail of the derogation can be found in section 5 (2) of S.I. No. 36/2019 - Medicinal Products (Safety Features On Packaging) Regulations 2019.
SOP for the verification and decommissioning of medicines using ezFMD to ensure Falsified Medicines Directive (FMD) compliance
To support hospital pharmacists healthcare institutions, the HSE, in collaboration with key stakeholders in the Department of Health, the Irish Medicines Verification Organisation (IMVO), and others within the medicines supply chain have developed a standard procedure for the verification and decommissioning of medicines using bespoke software, (ezFMD) to ensure compliance with the Falsified Medicines Directive (FMD).
The purpose of this SOP is to ensure compliance.
To achieve this it outlines the :
- the background behind FMD
- compliance requirements
- the software and hardware platform to ensure compliance.
It is a guide for updating site-specific SOPs relating to goods inwards and dispensing.
To obtain a copy of the FMD SOP or if you have any FMD-related queries, please contact FMD.Support@hse.ie.
FMD use and learn period ends in Ireland 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 ends for hospital pharmacies and laboratories on 30th May 2022. After this date hospitals 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 hospital pharmacies and laboratories on what to in the event of an alert and is available on the IMVO website (www.imvo.ie).
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
Monday to Friday 8am to 8pm
Saturday 9am to 6pm
Sunday and public holidays 11am to 6pm
HSE FMD Project Team
Queries re FMD: HSE.Support@ezfmd.com
