Market Authorisation Holders
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
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.
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.
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:
- 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).
An exception application must be submitted by the MAH before August 1st each year.
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.