The EU Directive on Falsified Medicines (2011/62/EU) means that as of 9th February 2019 there must be new security measures in place on almost all prescription medicines. The verification system will work throughout Europe, with the aim to improve patient safety by preventing falsified medicines entering the legal supply chain.
Before the pharmacist can dispense the medicine to the patient, they must scan a 2D matrix on the medicine pack. The information in the matrix will be compared to a database, which will confirm to the pharmacist that the medicine is not falsified. The pharmacist will also check that the anti-tampering device on the pack has not been broken. Assuming all is ok, the pharmacist can then dispense the medicine and the patient can feel secure that it is genuine.
The process is quick and it’s unlikely the patient will notice the system at all in the pharmacy.
The pharmacy will also continue to sell medicines without the 2D matrix. The patient can rely on the safety of all medicines in Finnish pharmacies.
The system must be running by 9th February 2019. Many supply chain stakeholders are already using the system.
The rules cover almost all prescription medicines and a few non-prescription medicines. Non-prescription medicines will only require safety features where there has been a known incident of falsification and the product concerned is listed in Annex II to the Delegated Regulation. Veterinary medicines are excluded. More details can be found here: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf
The directive states that the pharmaceutical industry (original and generic manufacturers and parallel importers) will have to fund the establishment and operation of the pan-European verification system.
This means that every company wishing to have a product sold on the Finnish market after 9th February 2019 will have to pay an annual fee to FiMVO.
In order to keep your products on the Finnish market you must sign the 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: email@example.com
It is the marketing authorization holders who shall register and enter the agreement, but 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 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.
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: firstname.lastname@example.org .
In addition to the normal regulatory requirement, manufacturers/parallel importers must upload their product data onto the European hub. A prerequisite to this is to enter a contract with the European Medicines Verification Organisation (EMVO). This is called Onboarding, and you are referred to as Onboarding Partners (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.
You need to enter a contact with FiMVO, fill out a user agreement and send FiMVO a copy of your pharmacy permission.
Who signs the contract?
This is your internal decision as to who has authority.
If the signee represents more than one entity, all entities fall under one contact but must be listed in part 1 (ii). The contract should be signed by hand, scanned and sent as a pdf to email@example.com .
Each entity should fill out a separate user agreement in Word, no signature in necessary, and sent to firstname.lastname@example.org .
When a pharmacy owner leaves its pharmacy, they should send us an inactivation request. If they take up a new pharmacy, they must fill out the new pharmacy's End User Contract, the End User Agreement, and send a copy of their pharmacy license, a minimum of 30 days before the new pharmacy begins operation.
It is fundamental that any problems with the system must not disrupt delivery to the patient. The system has a buffering system, that will collect data if the system is not working. In emergencies a web based service can be used.
FiMVO are currently working on a process document which will be released soon and give insight to different problem situations.