Market Authorisation Holders
CONNECTING WITH EtMVS
MAH’s whose products have been uploaded to the EtMVS or MAH’s who wish to upload their data need to have a contract with REKS. With the contract, MAH needs to pay the annual fee to REKS according to the Commission’s Delegated Regulation number (EU) 2016/161, article 31 clause 5, which regulates that MAH’s will pay the annual fee to uphold and manage the system.
To sign the contract, please contact REKS by email info(at)reks.ee. REKS will provide the contract template and information for the next steps.
EtMVS ANNUAL FEES
The annual fee and exceptions will be decided by the Board of REKS each year no later than in the fourth quarter. The exceptions will depend on the turnover. From 2023, MAH does not need to apply for the exception with a separate submitted form. The invoices will be issued based on the turnover statistics gathered by the State Agency of Medicines.
The invoices will be issued in the second quarter. If the recipient of the invoice wishes to dispute the level of exception that is issued (based on the turnover), it is possible to do so within 2 weeks of receiving the invoice.
The annual fees will be published on REKS’ website and MAH’s in contract will be informed by email. The invoices will be issued on the second quarter.
TERMINATION OF MAH AGREEMENT
To terminate the contract with REKS, we kindly ask the MAH to send an email with the following content to info(at)reks.ee: “Please terminate the contract of MAH XXX contract number 4.2-2XX.XX from dd/mm/yyyy.” Please also provide a reason for the termination. The email sender, or at least in the copy of the email, should be the person who signed the contract, that is, the MAH’s legal representative with the right to sign. The annual fee already paid shall not be refunded upon termination of the contract.
INQUIRIES REGARDING THE PRODUCTS UPLOADED TO EtMVS
MAH’s who wish to check the data upload to EtMVS or ask information about the EtMVS can do so by emailing to info(at)reks.ee.
Data in EtMVS system is not for public use and only the owner of the data or supervisory authority can require information about it from RKES. Due to the above, REKS will only provide information about EtMVS data to a person who:
- has MAH signature/representation rights;
- has been designated as a contact person in the contract with REKS;
- as been submitted to REKS in writing by the aforementioned persons as an authorised person, in respect of whom the name, e-mail address, telephone number and position have been indicated.
It is possible for MAH to name a designated wholesaler. This definition gives the wholesaler the opportunity not to verify given MAH medicines, as the wholesaler can confirm it is in the controlled supply chain.
Further details on these functions are described in the EMVO Master Data Guide (Master Data Guide).