In order to keep your products on the Finnish market you must sign an agreement with FiMVO. This is available here: https://www.laakevarmennus.fi/en/pharmaceutical-companies
If you have any queries, please do not hesitate to contact us: firstname.lastname@example.org
It is the marketing authorization holders who shall register and enter the agreement. However, representatives, manufacturers and parallel importers can enter the contract on behalf of their MAHs, by listing the MAHs in the contract, in appendix 2.
The fees are based on the FiMVO budget. FiMVO applies the flat-fee/MAH model recommended by EMVO. This means the number of MAHs on the Finnish market will affect the fee per MAH.
Please note that the fee is based on marketing authorisation holders, not marketing authorisations. If a company represents more than one MAH, the fee will be charged according to the number of MAHs.
The annual fee range estimation is 6 000 – 10 000 euro/MAH
The fee will be charged annually in January. However, the first payment was charged in August 2018 covering September – December 2018 and the annual fee for 2019.
The annual fee covers the yearly running costs of FiMVO. This includes the running costs of the Finnish Medicines Verification System (FiMVS), FiMVO’s share of the European Hub costs and FiMVO governance costs.
The setting up has been funded by pharmaceutical industry stakeholders by means of a loan. To be able to pay back these loans, FiMVO will charge a ramp-up fee from all MAHs. The ramp-up fee will cover for the costs of setting up the system in 2016-2018.
The ramp-up fee range estimation is 5 000 – 8 000 euro/MAH. It will be charged in two instalments, one half in January 2019 and the other half in January 2020.
If the MAH does not have serialised products on the market and does not intend to bring such products on the market, a contract and the resulting fees are not necessary.
This depends on how the companies have contracted between themselves. It is sufficient to pay the FiMVO fees only once, but it is the responsibility of the companies to decide who will list the MAH in the Annex 2 of the FiMVO contract.
If you already have a valid contract with FiMVO, you should update Appendix 2 to your current MAH list. If you do not have a contract with FiMVO, you should contact FiMVO at email@example.com for contract information.
In addition to the normal regulatory requirements, manufacturer/parallel importers must upload their product data onto the European hub. A prerequisite to this is to enter into contract with the European Medicines Verification Organisation (EMVO). This is called Onboarding, and you are referred to as Onboarding Partner (OBP). Detailed information and an explanatory step by step video can be found on the EMVO website.
Generally, no. It is the Marketing Authorisation Holder (MAH) who registers and enters an agreement with FiMVO. However, it can also be the representative of the MAH or the manufacturer who enters the agreement. In this case, the MAHs must be listed in Annex 2 of the agreement.
Yes, you can still include an EAN code on the pack. Please note that the EAN code may not hold contradicting information with the 2D matrix. E.g. the product code (GTIN) must be the same in both data carriers.