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    Reminder to marketing authorisation holders and manufacturers of medicines concerning the rules of safety features

    01.02.2019
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    The manufacturers are to ensure that since February 9, 2019 all prescription medicines released for sale or distribution in the EU are carrying the safety features (the unique identifier and the anti-tampering device).

    In order to ensure the availability of medicines, the marketing authorization holders must sign contracts:

    • with the European Medicines Verification Organisation to enable the upload of the required data on the  unique identifier to the  repository system
    • with the National Medicines Verification Organisation (who are responsible for setting up the national repositories) in the Member State where they market their medicinal products. In Estonia, the organization is the Ravimite Ehtsuse Kontrolli SA (REKS).

     

    As of now, it is known that many manufacturers have not yet uploaded sufficient data to the repository system but the packages of medicinal products with safety features are already available at pharmacies. We already have problems with the availability of medicines in Estonia and the situation will only get worse if the obligations have not been fulfilled on time. In order to ensure patient care, it is of utmost importance that contracts are signed and the data is uploaded into the repository system. We ask the manufacturers and marketing authorisation holders to hurry with it and pay attention to the fact that the uploaded data is correct and complete.

    See also:

    https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/ 2018_letterstakeholders_safetyfeatures_en.pdf