The Slovenian National Medicines Verification System will also be established (SiMVS) as part of the European medicines Verification System (EMVS), all based on and in accordance with Directive on Falsified Medicines 2011/62/EU of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain  of falsified medicinal products (Directive) and Commission Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Delegated Regulation).

In Slovenia, ZAPAZ (MVIS) will develop, test, establish, implement and maintain SiMVS.

For the establishment and maintenance of SiMVS (and involvement in the EMVS), MVIS needs adequate financial resources. In accordance with the Directive and the Delegated Regulation, the costs for the operation and maintenance of MVS, as well as the costs of financing of the implementation phase, are covered by the marketing authorization holders with validity for the relevant market. Marketing authorization holders for a medicinal product with effect on the territory of Slovenia (MAH) shall therefore bear the costs of SiMVS. MVIS will process the data only of those MAHs who will (directly or through is representative) conclude the cooperation agreement (Agreement) and fulfill the agreed obligations, including the obligation to pay the agreed fee(s).

MVIS has invested a lot of energy in negotiations with the supplier to ensure the lowest possible cost of the system, and it also undertakes in the future to maintain optimized operating costs. The amount of the fee is part of the MVIS’ financial plan, which is adopted and approved by the MVIS’Council consisting of representatives of the founders, i.e. Forum of International Research& Development Pharmaceutical Companies, EIG, Association of Slovenian Medicinal Products Manufacturers, Slovene Chamber of Pharmacies and Slovene Chamber of Commerce – Section of medicinal products wholesalers.

Regarding the level of fee, we explain as follows: The height of the annual fee for the years 2019 and 2020 includes, in addition to covering running costs of technology information and operating costs, also the amounts of borrowed and/or prepaid funds that have enabled, are enabling and will enable the implementation of SiMVS in 2016, 2017 and 2018. Fees for the year 2021 and further will no longer include the refunding of borrowed or prepaid funds and is therefore expected to be lower. However, in all years, the amount of annual fee depends on how much MAHs have entered into the Agreement and pay the agreed fee. Given the estimated assumption that the Agreement will be concluded with approximately between 140 and 170 license holders, the annual fee in the years 2019 and 2020 will be € 10,000 per year. Any surplus of funds will be transferred in the next years (2021 and later).

On the following link you can find the draft of the Agreement:

https://www.zapaz.si/wp-content/uploads/2018/01/MVIS-MAH-Cooperation-Agreement_ENG.pdf

In order to facilitate the planning and implementation of all activities, we would like the majority of all Agreements between MVIS and MAHs (or their representatives) to concluded until 30 June 2018, therefore a system of increases of the Annual Fee is also foreseen, which motivates MAHs to sign the Agreement and submit it to MVIS before June 30, 2018. To avoid any doubt, the moment of signing the Agreement has no effect on the dynamics of the annual fee, but only on the amount of annual fee, so that we recommend that you sign the Agreement and submit it to us (MVIS) as soon as possible, before June 30, 2018.

For additional information and assistance, we are available at office@zapaz.si or telephone +386 8 200 72 78.

Sincerely,

ZAPAZ (Medicines Verification Institute of Slovenia)

Mitja Pirman, director

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