Falsified Medicines Directive: end of transition period and beginning of monitoring activities

date: 30/08/2019

The transition period for the implementation the Falsified Medicines Directive (FMD) ends on September 1, 2019. From that time, alerts will be centrally evaluated and the FAMHP will start the monitoring activities through which violations and non-conformities will be followed up. 

From February 9, 2019, most of the prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed.

Circulars 644 and 647 provided practical guidelines on the roll-out of the verification system. The memoranda set a transition period until September 1, 2019. In the interim, mutual efforts of the stakeholders have led to a stable system and a significant reduction in the number of false alerts. Thus the system will come into full effect from September 1, 2019.

Central evaluation of alerts
False alerts can always be prevented by scanning the packaging by the pharmacy, wholesaler or manufacturer. So it is not always about a falsified medicine. Double scans or known problems with the coding of the expiration date can emit alerts. After consultation between the FAMHP and the BeMVO, it was decided that the BeMVO will filter and evaluate alerts in the first line. Pending the evaluation, a package that alerts can be delivered by the pharmacist or distributed by a wholesaler-distributor. If the alert cannot be explained by a known cause, the FAMHP will investigate this further.

Thus it remains very important that pharmacists scan all delivered packages to guarantee correct traceability. These are medicines that are not delivered by prescription and yet must bear a two-dimensional matrix code (such as for possible reimbursement). In this way, the pharmacist can take their responsibility if a problem is detected by the BeMVO and the FAMHP and where necessary, contact the patients who received the medicines as quickly as possible to recall them. The pharmacist thus remains responsible for the delivered medicines.

Control actions and follow-up of violations and non-conformities
The FAMHP will organize monitoring activities in the fall to inspect the correct use of the verification system in all affected sectors, in production, distribution and delivery. The FAMHP will use risk analysis for this, in which non-use of the system, the system not being connected, upload of incorrect information or not uploading certain information can lead to an investigation and inspection on site if necessary. When FAMHP inspectors detect violations, these will be followed up. Sanctions can range from official notifications of fines to legal action. If actors involved have fundamental problems fulfilling their obligations, they must notify the FAMHP as quickly as possible.

The system has already effectively been proven in another member state that it can intercept falsified medicines. It is therefore logical and essential that all affected parties make the necessary efforts to fulfil their legal obligation. So that patients get the authentic medicines to which they have a right.

Last updated on 17/09/2019