The Falsified Medicines Directive dates back to June 2011, when a proposal was adopted by the European Commission. At that point, the directive was primarily focused on regulating the supply chain and introduced: measures to tighten controls on the wholesale distribution of medicines; more robust rules regarding the control on starting materials and inspection of producers of active substances; and, a common, EU-wide logo to identify legal online pharmacies as well as to establish a notification system for entities offering to supply medicines to the public over the internet. All of these fall under the remit of the HPRA for regulation and compliance.
Subsequently, in 2016, a Delegated Regulation (DR), was published which introduced a new obligatory authenticity safety feature which must appear on the outer packaging of designated medicines and be used for authentication before being supplied to a patient. The DR came into effect in Ireland on 9 February 2019 and, as the HPRA has no regulatory reach over community pharmacy practice, falls to the PSI for regulation and compliance.
As a requirement of the DR, the Irish Medicines Verification Organisation (IMVO) was set up to deliver the national system (called the IMVS) and to approve the IT systems used in your pharmacies to connect to the IMVS.
Since February 2019, we have been in a ‘Use & Learn’ period, where you were required to authenticate packets by scanning them, but could continue to supply them to patients irrespective of the message back from the IMVS. From 30 May, the ‘Use & Learn’ period will end and you will be required to withhold a packet from supply if a red alert implies the pack might be falsified. More information is available in our FAQ.
With the End of ‘Use & Learn’ for FMD fast approaching, there are a number of areas that concern our members:
- General sentiment towards FMD
Our position with the Department of Health is very clear, this is simply not a priority for community pharmacies and without adequate resourcing for this process, we will only be able to allocate limited resources to this activity;
- How to manage alerts
IMVO is responsible for the IMVS which generates alerts, and any feedback should be provided to alert.support@imvo.ie;
- IT problems
IMVO approves all IMVS software and is best placed to provide advice on providers and take feedback on technical issues e.g., software running in incorrect mode, alerts not making sense, etc. You can contact IMVO on info@imvo.ie; and
- Correspondence from the PSI
If you receive correspondence from the PSI relating to scanning activity in your pharmacy our advice is you should reply to and acknowledge or clarify the scanning activity in your pharmacy, describe the disruption it adds to your dispensing workflow and the efforts you can make to maintain compliance.
For more information, visit our dedicated FMD page.
