Updated 30.09.2020

Summary of the Test Period

In the period 22.06-12.07, REKS in cooperation with end users and the Estonian State Agency of Medicines, conducted a test period to map possible problem areas at the end of the transition period. REKS also tested the new alert management system REK-IS, which enables to speed up the alert management procedure and ensures an immediate response to end users 24/7.

Approximately 50% of the alerts received through the alert management system REK-IS during the test period were processed automatically. A more detailed summary of the test period is available on REKS’ website*:

The reflections and suggestions of the test period by the end users were also reflected in webinar in August, which can be viewed on REKS’ website: REKS also prepared a new shot guide for users, which is primarily intended for printing; the State Agency of Medicines also supplemented its instructions. Instructions can also be found on REKS’ website:

*all links mentioned in this section have unfortunately information only in Estonian.

The End of Implementation Period

As of September, the implementation period regarding the medicine’s verification ended in Estonia. The main changes in this regard are as follows: all alerts raised are processed by REKS. Medicines that raised an alert must not be dispensed by the end user until the reason for the alert has been established. As the only exception, according to the guidelines of the State Agency of Medicines, it is permitted to dispense the last package if the dispenser is convinced of the safety of the product and ensures patient data in case it becomes necessary to recall the dispensed medicinal product.

Alert management system REK-IS

Due to the need to make the alert management process as operational as possible and to ensure the rapid dispensing of medicines, REKS developed software that allows immediate information on medicines confirmed as exceptions (if the alerts is forwarded through the alert management system) and the end user to decide on dispensing. In addition, the system provides the end user with an additional e-mail that meets the required documentation of the alert case.

At the moments REKS has published information about the exceptions on its website, which will be waived in the future and the corresponding information will remain available through the alert management system.

In the 3rd quarter, the end user information systems were interfaced with the alert management system. To date, approximately 50% of end users of the main information systems have signed a contract or are in the process of signing an interface agreement. REKS has contacted all users and informed them about the possibilities of joining the procedural system. If the end user does not want or cannot create an automatic interface for technical reasons, the functionalities of REK-IS alert management system (automatic response, etc) are also possible if the alerts are sent to REKS via a web form (available via the REKS website).

The usage of the alert management system is a free of charge for all REKS partners.

Renewal of MAH contracts

Due to the changes in the financial model approved by the REKS Supervisory Board in June, the MAH agreements will be renewed. The need arises from lowering the rate of annual fees below the level provided for in the agreement. The procedure to apply for exceptions has also been made more flexible. During the third quarter, REKS has send out a new contract form with the necessary information to all marketing authorisation holders who are REKS’ contract partners.

REKS thanks all its partners for successful and pleasant cooperation and wishes a beautiful autumn!

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