FiMVO Newsletter 4-2018

Less than one hundred days until medicines verification - are you ready?

There are less than sixty working days until the official start of the new regulation for medicines verification. The supply chain has been feverishly preparing for medicines verification for a few years. Although much has been done, open issues and questions still remain

Almost all countries medicines verification systems are operational and ready to receive pack data from the pharma industry. The Finnish system has been operational since summer. Almost all wholesalers and some pharmacies are already connected.

Is the pharmaceutical industry ready?

So far, unfortunately very little data has been uploaded onto the system. We currently have about 40 marketing authorization holders in our system. In Finland, there are just over 300 marketing authorization holders, so the vast majority are still missing. The situation is no better on a European level, as a truly significant number of companies are also missing from the Hub's central database.

It is very likely that a large number of packs will be released before 9 February 2019 which will not be serialised. Such packs may be on the market until the end of their expiry. If a company plans to release a large number of such packs, it would be very useful to inform the wholesalers. Sudden large quantities can pose logistical challenges and the wholesalers want to prepare for this.

About 30 pharmacies are currently connected to the Finnish medicines verification system, some of which are actively piloting the system. At present, more than half of the scans (verification / decomissioning) fail. The majority of unsuccessful scans are due to the fact that pharma companies have not uploaded their unique identifier data to the system. We strongly encourage companies to ensure that data is uploaded to the system as soon as possible! Please note that this should be done also retrospectively.

When system alerts are enabled, packs which do not have data uploaded on the system will cause an alert in the wholesaler or pharmacy. Such packs can no longer be dispensed to the patient after 9.2.2019.

Pilot experiences show that the pharma industry should also pay attention to the quality of the data in the system. The product codes, GTINs, must be correct, and the data in the system must match the information on the pack. Based on the experience so far, this is not always the case. Such packs will also cause an alert.

Process descriptions under progress

Alert handling and other exceptional cases are currently causing some concern and debate. FiMVO is preparing a process description that answers questions such as alert handling. In some areas, finalizing the process still requires The Finnish Medicines Agency Fimea’s perspective.

The process description has been developed in cooperation with all supply chain stakeholders and will be piloted before the introduction of the system. Process descriptions are also being developed on a European level. As much as possible, European processes will be taken into account in the Finnish processes as well.

We will publish the process descriptions as soon as possible.

Report exceptional cases to FiMVO

There are packs on the market that have been serialized according to requirements outside the EU.   Mainly this concerns packs manufactured in India, whose serialization markings look externally the same as EU serialisation. If a company has such packs, it is advisable to contact FiMVO as soon as possible. This pack information can be passed on to pharmacies and wholesalers, so they do not cause confusion in the supply chain.

FiMVO should also be notified of all other exceptional cases. It is known that there will be packs in the supply chain with a 2D matrix and whose information has been entered into the medicines verification system. However, there is no anti-tampering device on the packs. In order to ensure that such packs do not cause confusion in the supply chain after February 2019, it is advisable to pass on the information to the wholesalers and pharmacies.

The supply chain's readiness for medicines verification

Our goal is that all pharmacies will be connected to the Finnish medicines verification system by the beginning of December. Pharmacies will introduce the system gradually by the beginning of February.

The three largest wholesalers are already connected and the missing wholesalers will be switched on as soon as possible.

In the case of hospital pharmacies and dispensaries, connection will stretch until the end of January. It is likely that all units will not be connected by the beginning of February.

Have you already signed a contract with us?

As far as end-users of the system, especially hospital pharmacies and dispensaries are concerned, we still lack a significant number of contracts.

The medicines verification system can not be used without the end user having a valid contract with FiMVO. Without this, medicines can not be dispensed after 9 February 2019. If your organization does not yet have an agreement with us, please contact us as soon as possible (katriina.newton-kolehmainen@fimvo.fi).