Market Authorisation Holders

Market Authorisation Holders

               Updated 02.05.2019

ALERT HANDLING
At the moment, Estonia has soft implementation period.

Pharmacies and hospitals will need to alert REKS, if the pack status is “active” then at the moment, they can release it. However, if the pack is “inactive state”, they cannot be released, and they have to inform REKS and the Estonian State Agency of Medicines. These institutions will investigate the situation.

If wholesaler gets an alert, they will need to notify MAH to investigate the reasons. The pack must be put into quarantine and can’t be released before MAH gives feedback. Wholesaler can only deliver the package with written letter from MAH confirm that product (GTIN) and batch is correct. When MAH responses to the wholesaler, REKS kindly requests to be added in CC (help@reks.ee).

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@reks.ee

MAH AGREEMENT
The key steps to be undertaken to comply with the new requirements include:

  • Identifying what products are in scope of the new requirements and require safety features (as defined in Article 2 of the Commission Delegated Regulation (EU) 2016/161).
  • Changing packaging to include safety features and having it approved by the regulatory authority.
  • The Manufacturers need to upgrade production lines to apply the unique identifiers and anti-tamper device.
  • Onboarding to the EU Hub which is managed by European Medicines Verification Organisation (EMVO) to be able to upload product data to the EU Hub – see EMVO website for details of onboarding process which has both contractual and technical elements.
  • Uploading unique identifier data that has been placed on packs to the EU Hub. The data will then transfer from the EU Hub to the national repository for the market where the packs are intended to be sold.
  • It is important to ensure that the uploading of data for products distributed in Estonia, is done after the Estonian National Medicines Verification System is connected with the EU Hub.
MAH contract with REKS
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@reks.ee to receive the contract template with further instructions.

  • The contract has appendices where the contract signer can name the represented MAH’s and their information.
  • If you need to update the contract (e.g. appendices, invoice information etc.) please contact with info@reks.ee.

    FINANCIAL MODEL
    REKS Supervisory Board has agreed on the flat fee with four different exceptions for the MAH’s operating on the Estonian market as follows:

    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@reks.ee.

     

    Back to Top