FiMVO Newsletter 3-2018
The first package has been piloted in the Finnish Medicines Verification System in a pharmacy
We have achieved a major milestone in the introduction of Finland's medicines verification system. On Thursday 13th September the first pack was piloted by a pharmacy. The unique identifier of the package, i.e. the serial number and product code, was successfully decomissioned from the system. We also tested the undo process. The system worked exactly as it should!
The first pilot was performed on Santen Oy's Taptiqom product, which is a medicine used for glaucoma. This was done at Pajamäki's pharmacy, whose information system is supplied by Receptum Oy.
"I'm really happy with this first pilot. Once again, we have taken a major step forward with the introduction of the medicines verification system," says Finnish Medicines Verification Organisation General Manager Maija Gohlke-Kokkonen. "Our aim is that the system will be fully operational before the deadline set by the Commission. This is a great step to go forward from," continues Gohlke-Kokkonen.
"Santen is proud to be the first company whose product was piloted in the Finnish medicines verification system. Medicines verification will further increase the safety of the pharmaceutical supply chain which will benefit the Finnish patient. By purchasing medicines from a legal pharmacy or online pharmacy, the patient can be confident about the authenticity of the medicine, "says Katri Outinen, Managing Director of Santen Oy.
"The introduction of a medicines verification system is a challenging task for the entire pharmaceutical supply chain. With good co-operation we have stayed on schedule. Our goal is that all our customers will be connected to the system by December, "says Mika Weckström, Head of Development at Receptum.
"Finnish pharmacists are ready to join the medicines verification system. Patients have always been able to trust the authenticity of medicines, as to this date no falsified medicine has ever reach a Finnish pharmacy," says Charlotta Sandler, Expert Pharmacist of the Finnish Pharmacy Association.
Contracting final hour!
All outstanding MAH contracts have been returned, and we have started our first invoicing round. MAH fees are being collected, covering the period of September 2018 – December 2019. Our next invoice will be sent in January 2019, which will cover half of the ramp up fee. The second half of the ramp up fee will be invoiced in January 2020. We will finalise the sum in December 2018, but the total cost is most likely to be between the previously announced
EUR 5 000 - EUR 8000.
Any MAHs needing to sign up with us should do so as soon as possible, we only have 5 months to go until 9.2.2019.
End User contracts are in the process of being returned, this should be ready by the end of October. We are still waiting for many contracts especially from the public and private dispensaries. Please send your contracts as soon as possible to ensure smooth sailing and an uninterrupted supply chain come 9.2.2019.
The medicines verification system can not be used without the End User having a valid agreement with FiMVO. Without medicines verification, medicines can not be delivered 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).
FMD in Finland will soon be in production
The Finnish medicines verification system has been in production since June 2018. The production release from Arvato Systems is 1.1 (current official release is 1.01.008.3). The EU Hub release was also updated to 1.4 on 20.8.2018.
This is the EU Hub’s final production release before 9.2.2019, but our Finnish system (FiMVS) will still update to version 1.2 before the end of this year. The actual release installation date will be around the end of November/early December 2018. This release will include intermarket transactions and product withdrawal.
Reports for the national competent authorities will be implemented in the 1.3 version and released in 2019, because the report descriptions are not finalized yet.
We have approximately 130 products in our system from about ten pharma companies. There are also batches for 20 products in the system. We are piloting the system with 8 pharmacies. After initial experiences, pharmacies will be connected to the system in batches. Our aim is to have all pharmacies connected by the end of November.
Quality Corner
The document Suomen lääkevarmennusjärjestelmä FiMVS (Finnish Medicines Verification System) v1.0 describing the processes of the medicines verification system was approved on 28 Jun 2018. The document has been created in cooperation with the different stakeholders with the aim of helping them to update their own internal processes and procedures. Because some changes and clarifications have already been identified in certain processes, the document will be revised and updated during this autumn and the aim is to publish the next version by the end of October. This version will be published on the FiMVO website.