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Q1:                What are the fees based on?

A1:       The fees are based on the FiMVO budget. FiMVO applies the flat-fee/MAH model recommended by EMVO so the number of MAHs on the Finnish market will affect the fee per MAH. Currently there are approximately 300 MAHs on the Finnish market.

Please note that the fee is based on marketing authorization holders, not marketing authorisations. If a company represents more than one MAH, the fee will be charged according to the number of MAHs.

Q2:      How much are the fees?

A2:       Annual fee                                                                                In 2019 the annual  fee is 6 800 euro/MAH

The fee will be charged annually in January.

Set-up fee                                                                                 5 900 euro/MAH

The set-up fee will be charged in two instalments (one half of the set-up fee) in 2019 and 2020.

Q3:                What are the two different fees?

Q3:                There is an annual fee and a set-up fee. 

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 set-up fee will cover for the costs of setting up the system in 2016-2018. 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 set-up fee from all MAHs.

Q4:                What is the FiMVO invoicing period?

A4:       FiMVO will invoice annually in the beginning of the year.

            All MAHs registering until the end of 2019 will have to pay the full amount of the annual fee.
                     

FiMVO must be informed of the MAH invoicing details in the FiMVO-MAH contract Appendix I. Please note that the MAH is responsible to keeping the invoicing details up to date.

Please note we apply a 30 days term of payment set out in the contract.

1/2020 onwards

Estimated annual fee range 5 000 – 10 000 euro/MAH.

The fee will be charged in January each year.

New MAHs registering in and after January 2020 will be charged from the registration quarter onwards.  

 

Time of registration

Fee

January- March

Full annual fee

April – June

3/4 of annual fee

July-September

2/4 of annual fee

September – December

¼ of annual fee


                     

Q5:      If a company will not have serialized packs on the market after February 9th 2019 but still has unserialised packs on the market, will fees be charged?

A5:       If the MAH has no other serialised products on the market and does not intend to have such products on the market, a contract and the resulting fees are not necessary.

 

Q6:      If an MAH is represented by multiple companies, who is responsible for the fees?

A6:       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.

Q7:                What should be done if a new MAH enters or leaves the market?

A7        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: info@laakevarmennus.fi .

 

If you have any further questions, do not hesitate to contact us!

Communications Assistant, Katriina Newton-Kolehmainen: katriina.newton-kolehmainen@fimvo.fi