Marketing Authorization Holders
MAH
Interfacing with the Estonian database - EtMVS
A MAH whose medicines have been uploaded to the Estonian Medicines Authenticity System (EtMVS) or who wishes to upload data to the system must conclude a REKS contract. Under the contract, the MAH must pay an annual fee to REKS in accordance with Commission Delegated Regulation No (EU) 2016/161, Article 31(5), according to which the costs of administering this system are borne by the MAH.
To sign a contract with REKS, please contact info(at)reks.ee. REKS will send you a draft contract and information about the next steps.
How the EtMVS System Works and Annual Fees
The Medicines Authenticity Verification System is funded through annual fees paid by marketing authorization holders. These fees enable REKS to cover the administrative and development costs of the entire information system. The REKS Board approves the base rate (flat fee) for annual fees and, based on the implemented annual fee system, also the amounts of exemptions determined according to the marketing authorization holder’s turnover.
Processing of alerts
REKS will contact MAH if information from MAH is required to process a package that has received a warning. REKS initiates proceedings based on information received from end users.
Generally, REKS sends an email containing a link to the alert data, where MAH can also respond to questions submitted to them. The email is sent to menetlused(at)reks.ee. This is an automated email sent by the information system and cannot be replied to.
If the MAH has any questions or issues regarding packaging alerts, please contact help(at)reks.ee
REKS processes product alerts through the local alert management system REK-IS. Estonia has not joined the pan-European alert management system administered by EMVO.
All Estonian retail pharmacies are connected to the local alert system, and alert data is automatically transferred from the pharmacies’ information systems to the REK-IS system.
In addition, data can also be submitted via the REK website if necessary. The same system is used to manage Estonian Exceptions—a list of drug batches for which there are known and checked cautions in Estonia.
Article 33
(excerpt from the delegated regulation)
Uploading information to the database system
The marketing authorization holder or, in the case of parallel-imported or parallel-marketed medicinal products bearing a unique identifier equivalent to the requirements of Article 47a of Directive 2001/83/EC, the person responsible for placing such medicinal products on the market shall ensure that the information referred to in paragraph 2 is uploaded to the database system before the manufacturer places the medicinal product on the market or distributes it, and that this information is subsequently updated. That information shall be recorded in all national or transnational databases serving the territory of the Member State or Member States where the medicinal product bearing the unique identifier is intended to be placed on the market. The Center shall also store the information referred to in points (a) to (d) of paragraph 2 of this Article, with the exception of the batch number.