Market Authorisation Holders

Market Authorisation Holders

Updated 08.07.2020

ALERT HANDLING

At the moment there is soft implementation period in Estonia, so there is no separate procedure for all alerts that have been generated, and there is no need for quarantine if the handler is convinced that it is not a falsified medicine and that its dispensing is in accordance with the Estonian State Agency of Medicine’s guidelines.

If necessary, REKS will contact the Marketing Authorisation Holder (MAH) / manufacturer in order to determine the cause of the alert. On the recommendation of EMVO, MAH should respond within 2 working days to the NMVO’s request. We kindly ask the MAH to provide further notice for the longer response time.

If MAH has any doubts about the occurrence of an alert or its causes, please forward it to help(at)reks.ee. It is not necessary to send separate alert summaries as this information is available for REKS from the system.

In alternative, end users can verify the product from list which is available on REKS’ webpage (for example, Indian packages or the products released before February 9th 2019) https://www.reks.ee/menetlus/

As a preventive measure, MAH can inform REKS about any packages that might cause alerts in advance by e-mail help(at)reks.ee

MAH AGREEMENT
All MAHs need to sign contracts with REKS, which gives MAH the right to use the Estonian National Medicines Verification System and gives an obligation to cover the costs related to it.

Please contact info(at)reks.ee to receive the contract template with further instructions.

If you need to update the contract (e.g. appendices, invoice information etc.) please contact with info(at)reks.ee.

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

In order to make possible information requests more operative, but at the same time still ensure that any sensitive information does not fall into the hands of third parties, REKS can issue information about the products uploaded by MLH to EtMVS by e-mail to persons who are:

  1. has MAH signature/representation rights;
  2. has been designated as a contact person in the contract with REKS;
  3. 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..

DESIGNATED WHOLESALERS
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).

FINANCIAL MODEL
MAH’s operating in Estonia who handle serialised medicines are required to pay a flat fee for the use of the database.

Change in financial model

In June, Board of REKS approved a new financial model, according to which the annual fees for MAH’s will decrease from 2021. The new annual fee rates will be published on REKS webpage no later than in January. As an important change, the payment will no longer be made in the form of advances for the following year, as was necessary when the system was launched, but for the current year. Thus, REKS will issue invoices for 2021 in the second quarter of 2021. In 2020, no invoices will be issued to MAH’s.

In connection with this change, it is also necessary to renew all contracts with MAH’s in order to reduce the level of some annual fees below the minimum currently set in the contract (for exemptions). REKS will contact all MAH’s during the second half of the year.

The annual fee rates for 2020 are as follows. There are four exemptions to the charges.
2020 annual fee:

    • I    Flat fee        –   8 000€ – turnover over 100 000 €
    • II   Exception 1  – 6 000 € – turnover between 50 000 – 99 999 €
    • III  Exception 2 –  3 000 € – turnover between 8 000 – 49 999 €
    • IV Exception 3  –  1 000 € –  turnover between 1 000 – 7 999 €
    • V  Exception 4  –  100 €   –    turnover between 0 – 999 €

    2020 annual fee for MAH whose turnover is less than 3000 € can be reduced to 100€.

    If you want exception for 2020, please contact info(at)reks.ee.

 

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