Newsletter

REKS 4th QUARTER 2020 NEWSLETTER

Updated 23.12.2020

Processing of alerts

As of 16.12, 860 alerts has been processed by REKS, of which 626 or 73% were automatic, which means an immediate response to the end user and the possibility to dispense the medicine immediately.

  • 12 alerts waited at this point for a response from MAH
  • 16 alerts waited at this point for a response from the end user
  • 2 alert waited at this point for a response from the State Agency of Medicines

 

  • All figures are as of 16.12.2020 and will change within days depending on how quickly the response are sent

As of December, 87% of end users have entered into an agreement to use REK-IS. REK-IS allows the end user to receive immediate feedback on a medicinal product on the exceptions list and also to cover the required documentation needs related to an alert. Use of REK-IS is free for all end users. A few end users have announced that they will not use the solution with an information system interface. In the case of the latter solution, REKS kindly requests to send in the alerts via REK-IS web form, which can be found at REKS’ webpage. In this case, all the functionalities of REK-IS are available and the notification is also received immediately for the medicinal product included in the exceptions list.

Security audit

A security audit of REKS was performed in the period of November – December. The audit found REKS processes and the medicines verification system to comply with the requirements of ISO 27001:2013.

Renewal of MAH contracts

In the third quarter, REKS sent out renewed contracts due to the financial model change. By the end of the year, about 50% of the contracts have been renewed. REKS kindly reminds you that according to the updated financial model, MAH can apply for the exception from the 2021 annual fee during the first quarter. The exceptions application must be submitted by March 31st 2021 at the latest. More detailed information on annual fees is also available on REKS’ website https://www.reks.ee/en/mah-flat-fee/.

REKS thanks all its partners for successful and pleasant cooperation and wishes happy holidays!

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