After many years of preparation, the Falsified Medicines Directive (FMD) deadline of the 9th February 2019, has finally arrived.
The Falsified Medicines Directive (FMD) will be implemented tomorrow and all of the stakeholders that this legislation will affect should be ready for the changes that this will bring to the pharmaceutical industry.
Falsified Medicines Directive: Safety Features
To recap, the Falsified Medicines Directive legislation was first published in July 2011. The directive includes requirements for safety features to be placed at pack-level for certain prescription-only medicines.
These safety features include:
- An anti-tamper device (ATD)
- A 2D barcode which contains a unique identifier (UI)
This unique identifier should contain the following:
- Product code
- Serial number
- Batch number
- Expiry date of the product
The Falsified Medicines Directive delegated regulation states that '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.'
In order to verify a particular product the following steps must be carried out:
- The unique identifier must be authenticated and verified where possible.
- The anti-tamper device must also be verified.
FMD Verification Process
Verification is carried out using both a National Medicines Verification System (NMVS) and a European Medicines Verification System (EMVS).
Each European country will have a National Medicines Verification Organisation (NMVO) in charge of the national system. E.g. The Irish Medicines Verification Organisation (IMVO) will manage the Irish Medicines Verification System (IMVS). These systems will store the information surrounding known legitimate medicinal products.
When a product unique identifier (UI) is scanned, the attempt is made to verify the product. During this verification process, data is transmitted to the national system and cross-checked against the known products. If the product is not found in the national database, the check is then forwarded to the European Medicines Verification System (EMVS).
If a product is verified, it can then be decommissioned and its status changed in the NMVS from 'active' to 'inactive-dispensed'.
However, a product may not be found in either the national or European databases. Therefore, the product cannot be decommissioned successfully and an alert is generated. In this case, the product must be quarantined and investigated further to establish whether the product has been falsified.
FMD Verification & Wholesalers
As outlined below by the IMVO, wholesalers may need to verify products in certain circumstances.
"Pharmaceutical wholesalers across Europe will be required to verify medicines bearing safety features that pass through their warehouses in specific circumstances as set out in the Commission Delegated Regulation (EU) 2016/161. They will also have to decommission packs in certain circumstances, including when they are being supplied to specific customers as per Article 23 of the Delegated Regulation."
The IMVO provides the following guidance for wholesalers in Ireland:
"In summary, this means that wholesalers will be required to verify and decommission medicines bearing safety features prior to the supply to all those entities listed in (b)-(k) and also persons authorised or entitled to supply medicinal products to the public who are NOT a hospital or an in- or outpatient/day patient clinic or health centre under the management or control of a hospital, for example, GP surgeries. Hospitals and in- or outpatient/day patient clinic and health centres under the management or control of a hospital are required to verify and decommission medicines themselves prior to dispensing/administration.
Wholesalers are advised to review their customer database as soon as possible to determine which customers will require verification and decommissioning of medicines bearing the safety features prior to supply.
Article 23: “Member States may require, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions:
- (a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
- (b) veterinarians and retailers of veterinary medicinal products;
- (c) dental practitioners;
- (d) optometrists and opticians;
- (e) paramedics and emergency medical practitioners;
- (f) armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;
- (g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions;
- (h) prisons;
- (i) schools;
- (j) hospices;
- (k) nursing homes.”
As outlined by the PSI (Pharmaceutical Society of Ireland), there will be a 'pragmatic approach' to the adoption and implementation of the Falsified Medicines Directive.
The PSI indicates that the agreed approach is as follows:
- "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."
The above details give a high level overview of the Falsified Medicines Directive and its proposed implementation from the 9th February 2019. Additional resources regarding the Falsified Medicines Directive are available here should you require any further clarification.
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[i] The Pharmaceutical Society of Ireland: Pharmacy Practice: Falsified Medicines Directive: Medicines Authentication - Frequently Asked Questions, [Online], Available From: https://www.thepsi.ie/gns/Pharmacy_Practice/FalsifiedMedicinesDirective.aspx, [Accessed: 08/02/2019]
 The IMVO - Irish Medicines Verification Organisation, [Online], Available From: https://www.imvo.ie/information1/falsified-medicines, [Accessed: 08/02/2019]
 The Pharmaceutical Journal - Falsified Medicines Directive - FMD - How will it work? [Infographic], [Online], Available From: https://www.pharmaceutical-journal.com/news-and-analysis/infographics/falsified-medicines-directive-fmd-how-it-will-work/20204433.article?firstPass=false, [Accessed: 08/02/2019]