FiMVO Newsletter 1-2019
The beginning is finally here!
Implementing the medicines verification system has been a long, and admittedly sometimes tedious, project. But now we are finally approaching the magical date of 9th February.
Are we ready?
The Finnish system FiMVS is technically set up and functioning. We’ve had some hiccups but most of them have been solved quickly. Implementing such a huge IT system is bound to create a few more bumps but we’ve laid actions so we’re ready to act promptly.
The Finnish medicines supply chain has also agreed on communications principles and we are all working together to ensure concise and quick communication.
Implementing medicines verification will require the supply chain to look at its processes to make sure we can react quickly to possible problems. FiMVO has published a process documentation which will be updated regularly as we gather more experience.
You can find more information about the technical situation, on-boarding and verification processes below. We’ll also tell you about our soft launch approach.
We strongly encourage pharma companies to makes sure they upload data in the system as soon as possible. Please also make sure that you take good care of data integrity!
For the pharmacies, hospital pharmacies and dispensaries as well as wholesalers our message is to start using the system as soon possible. It’s vital we have everything set before the implementation date.
It’s been a long way getting here but the beginning is finally here!
Current situation with FiMVS
The latest production version was installed on 23.1.2019 and this will see us through to 9.2.2019. This release includes corrections to the previous November 2018 release, and the main changes are related to automatic alert handling and NCA reports.
The IT-company applications for the Finnish FMD project has all been tested except one, (which will still happen before the 9.2.2019 deadline) and all applications are in production. All private pharmacies have been connected to the system and the new pharmacy applications have been installed, but unfortunately there are still only quite few active private pharmacies in the FiMVS. Hospital pharmacies and dispensaries are technically ready to be connected to the system but only about 30 % of those are active. All wholesalers have been connected and 4 of the 6 are already active.
Pharma company uploads, both master data and batch data, have increased after the New Year, but at the moment there is still quite a lot of missing information. This can be seen because about 30 % of transactions in pharmacies create an alert in the system. Alerts are mainly either due to Unknown product code or Missing batch data. About 50 % of the pharma companies which have a contract with FiMVO have started to upload data into our system.
Medicines verification processes and the launch of FiMVS
We have published an updated version of the FiMVS Process Descriptions document in Finnish and in English on our web pages. We have also presented these processes to marketing authorization holders and end users and their IT suppliers in two separate workshops.
In order to ensure an uninterrupted medicines supply throughout the whole supply chain we have, together with the representatives of the supply chain, agreed on certain operating procedures which are not according to the above-mentioned process description document. These procedures will be implemented from 9 Feb 2019 onward and until we have gained more experience on the functioning of FiMVS and the amount of system alerts. During this so-called soft launch, certain system alerts caused by missing or incorrectly uploaded data will not be considered as indicative of a potential falsification by pharmacies, hospital pharmacies and dispensaries. The same applies also to wholesalers with regards to supplies according to Art. 23 of the Delegated Regulation (EU) 2016/161 or returns from pharmacies, hospital pharmacies, dispensaries and other wholesalers according to Art. 20 (a) of the DR. Due to the new operating procedures implemented by the supply chain, it is possible to ensure that these alerts have not been caused by batches released from 9 Feb 2019 onwards.
Distributors in Finland have agreed to verify at least one pack from each new serialized batch they receive as part of their incoming inspection. In the case of an alert, the distributor would initiate a deviation investigation due to a potential falsified medicinal product. The batch in question would not be transferred to saleable stock before the potential falsification had been ruled out as a result of the investigations performed.
By this above-described operating procedure the occurrence of the following system alerts can be prevented for batches released 9 Feb 2019 and onwards:
- unknown product code (product master data has not been uploaded in FiMVS/EMVS)
- batch data missing (product pack data has not been uploaded in FiMVS/EMVS)
- expiry date mismatch (expiry date encoded in the 2D data matrix does not match the expiry date uploaded in FiMVS/EMVS)
Since the occurrence of the three above-mentioned system alerts has been prevented by the previously described operating procedure for batches released from 9 Feb 2019 onwards, and FMD and DR are not binding for batches released before 9 Feb 2019, these three system alerts may be disregarded by pharmacies, hospital pharmacies and dispensaries, unless there is reason to believe the product is falsified. Likewise, wholesalers may disregard these system alerts if they concern supplies according to Art. 23 of the DR or returns from pharmacies, hospital pharmacies, dispensaries and other wholesalers according to Art. 20 (a) of the DR, unless there is reason to believe the product is falsified. Any of the previously mentioned system alerts alone do not indicate that the product may be falsified.
All other system alerts must be investigated as potential falsifications by all supply chain actors according to NCA guidance and regulations and own approved SOPs. These system alerts include:
- unknown serial number
- batch number does not match the serial number
- pack is inactive (dispensed, sample, free sample, destroyed, stolen)
- property is already set on pack (only alerts if pack is not found in FiMVS)
- alerts concerning undo transactions
During the soft launch, supply chain actors will monitor the performance of FiMVS and system alerts, and perform corrective actions, if required. When it can be ensured that missing or incorrect data of batches released prior to 9 Feb 2019 do not cause any unnecessary system alerts, the soft launch may be discontinued after a joint decision by FiMVO and the supply chain actors. From that point on, all system alerts will be treated as potential falsifications.
The soft launch does not mean that pharma companies are exempt from uploading data to the EU Hub. In order to ensure a working supply chain all serialized data must be loaded retrospectively.
Have you already signed a contract with us?
If you are an MAH who has not yet signed a contract with FiMVO, please make haste! Please also note that if you have not paid the first (and only) invoice we have sent out so far you will not be able to use our system.
We are in a good position with our end-users of the system, and are only lacking a small amount 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).
Invoicing
Ramp up fees will be confirmed in Q1. Invoicing details can be found on our website: https://www.laakevarmennus.fi/en/fimvo-invoicing-details
Contact us:
General Manager: Maija Gohlke Kokkonen - maija.gohlke-kokkonen@fimvo.fi
Operations Manager: Tero Vesa - tero.vesa@fimvo.fi
QA Manager: Teijo Yrjönen - teijo.yrjonen@fimvo.fi
Communications Assistant: Katriina Newton-Kolehmainen - katriina.newton-kolehmainen@fimvo.fi
LinkedIn: https://www.linkedin.com/company/fimvo-finnish-medicines-verification-o…
Twitter: @fi_mvo