REKS NEWSLETTER

Updated 12.04.2023

EtMVS

In the Second Quarter, the EtMVS Core and Rep systems will be upgraded to version 2.0. Installation in the test environment (IQE) will take place in April. Installation in the production environment (PROD) is planned for May. Versions 3.0 and 4.0 are under development, with completion deadlines at the end of this year and in the second quarter of next year, respectively.

International cooperation

The meeting of the quality and technical working groups of the Arvato countries will take place on April 20-21 in Riga. Another session of the EMVO General Assembly will take place on May 11. On May 15, a workshop organized by EMVO for National Competent Authorities (NCA) will take place. The OPS Summit organized by EMVO will take place in Brussels on May 16-17. Summit is aimed at conducting technical discussions of the system. A healthcare symposium organized by Arvato will take place in Berlin on May 23-24.

MAH

Starting from the Second Quarter, REKS will start preparing and sending out invoices to Marketing Authorisation Holders (MAHs). Compared to the previous years, MAH’s do not need to submit a separate application for exception this year. The basis for determining the exception is the statistics issued by the Estonian State Agency of Medicine on the turnover of MAH’s serialised products of the previous year. If the MAH does not agree with the issued invoice, please first check the MAH annual fees on REKS’ website (they have not changed compared to 2022) and then please contact REKS in order to find out the reasons for the difference.

Alerts

In the First Quarter of 2023, the number of alerts sent in via REK-IS has been stable. Also, the number of automatically processed alerts by the REK-IS system. The majority of alerts are related to an unknown product code (PC_01), of which about ⅓ are medical devices where the verification is not needed to be carried out by the pharmacy. A large share of the latter is related to the 2D code of the devices used for blood glucose determination, which triggers an automatic inquiry into the EtMVS system.

Exception list and medicine verification

The Estonian exception list is created in cooperation between the Estonian State Agency of Medicine and REKS for medicines whose verification has been previously done, but the package gives an alert. In many cases, batches are placed in the exception list based on the information from the manufacturer or wholesaler. The first alert related to the exception can also come from the end user, as a result of which the manufacturer or another competent institution confirms its authenticity and the permission to be included in the list of exceptions. From the point of view of identification, a photo of the package taken by the end user is definitely important.

The Estonian list of exceptions is managed by the REKIS system. Every notification sent by the end user goes through an automatic exception checking. If the batch is on the list, REK-IS will send an automatic response about it. In this case, the end user does not need to document anything additionally and can rely on the REK-IS notification.

The end user can also check if the batch belongs to the exceptions list from the complete list on the REKS website. The given list is protected with a password for security reasons (if necessary, you can get it by contacting info[at]reks.ee). The end user may decide to skip the verification of the batches added to the exceptions list. However, for the monitoring process, in such cases, one should make a note so later it will be possible to understand why there were more packs sold on the basis of prescription than package deactivations in the system.

The third option is that the verification has been done, but the alert or notification is not sent to REK-IS. In this case, the end user must write down an explanation for each alert received, why the package with the alert was still issued to the customer.

REKS thanks all its partners for effective and pleasant cooperation and wishes you a beautiful spring!