Market Authorisation Holders

Market Authorisation Holders

Updated 08.10.2020

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.

If MAH signed a contract with REKS before September 2020, due to the change of financial model (more down below) these contracts need to be changed. If you have not received a new contract yet, please contact info(at)reks.ee. The exact changes in the contract can be see HERE.

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 MAH 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.

 

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