FiMVO Newsletter 1-2018
FiMVO Newsletter 1/2018
FiMVO Communications
As our deadline grows closer (less than a year!) we’re keen to keep up to date with all involved! A lot is happening and we all need to keep on the ball.
For this purpose, we have launched our LinkedIn site, hoping to widen our message reach. Following us on LinkedIn is one of the easiest ways to keep up to date with our news, and news we receive and want to share.
https://www.linkedin.com/company/fimvo-finnish-medicines-verification-organisation/
We are also regularly updating our website, working to make it easy to find what you need, be you an MAH, End User, Wholesaler etc.
https://www.laakevarmennus.fi/en
This month we will also be launching an FAQ page which we hope will help, especially with contract queries!
The Finnish Medicines Verification System will go into production in late May
The implementation of the Finnish Medicines Verification is moving ahead. The system is currently being tested. The production phase i.e. use in real life is scheduled to begin end of May 2018.
Testing of the Finnish system takes place in the system's test environment (IQE). Initially, tests have been carried out with a few pharmaceutical companies. The aim is to establish that information coming from the European central repository, the Hub, is moving correctly into our national system.
In addition, tests will be carried out with system end-users, i.e. wholesalers and pharmacies. At this stage, about ten pharmacies are involved in the testing. First tests with pharmacy IT-suppliers will be held in week 10.
Wholesalers and hospital pharmacies will test the system later in the spring.
After the test phase, in May (the exact date will be announced later), the system will be used in production, i.e. real-life use. In order to implement the system in a controlled manner, pharmacies and wholesalers will be on-boarded in the system step by step. Pharmaceutical companies, on the other hand, can start to use the system as soon as they are connected to the Hub and have serialised packages coming to the Finnish market.
Signing up with FiMVO
All Marketing Authorization Holders as well as System End Users (pharmacies, hospital pharmacies, dispensaries and wholesalers) must sign up with FiMVO in order to use the system. Please find more information about the singing up procedure on our website:
MAHs: https://www.laakevarmennus.fi/en/sign-fimvo
End Users: https://www.laakevarmennus.fi/en/node/91
Quality Corner
The Quality Management System (QMS) of FiMVO is nearly complete with just a couple of SOPs still being preparedand available only as drafts. The aim is to have the rest of the SOPs approved and finalised during the spring.
The next project will be to describe the main medicines verification processes together with the stakeholders. This will be done based on draft process descriptions prepared by FiMVO. A workshop has been planned for 12 March 2018 and invitations have been sent to stakeholder representatives. Process descriptions for processes that affect all supply chain actors are expected to be finalised by mid-April. This is before the Finnish Medicines Verification System (FiMVS) v1.1 will be taken into productive use.
Based on these process descriptions; pharmacies, hospital pharmacies, dispensaries and wholesalers will be able to assess the need for change in their own internal processes as a result of the introduction of FiMVS.