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    Exemptions to the labelling and package leaflet obligations in Estonia

    18.05.2017
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    The package leaflet (PIL) and the package labelling of the medicinal products marketed in Estonia must be in Estonian.

    In exceptional cases, State Agency of Medicines may grant exemptions from approved packaging, if

    1) the medicinal product is no intended to be delivered directly to patients (hospital-use only or vet-use only medicinal products) or
    2) medicinal products with the same active substance and of the same strength are not distributed in Estonia and ensuring the continuous supply of the medicinal product is important from the point of view of human or animal health.

    The medicinal product in the European Economic Area (EEA) language packaging intended to be distributed in Estonia must otherwise comply with the terms of the marketing authorisation issued in Estonia (except the language of the package labelling).

    To apply for the exemption in the national language requirements, the marketing authorisation holder (MAH) must send the State Agency of Medicines a signed application to receive authorisation to distribute medicinal products in packaging of another member state of the EEA in Estonia. You can find the application form here.

    Each case is individually assessed, but the following information must accompany every application: language of the package labelling, reasons for the medicinal product to be distributed in packaging of another member state of the EEA and the number of packages to be exempted or the time limit intended for the exemption. A mock-up for the intended packaging to be used while the product is not available in approved packaging must also be forwarded to the State Agency of Medicines. The MAH can also apply for a permanent exemption in the national requirements of the labelling and PIL.

    It is equally important to ensure the safe use of the medicinal products distributed in foreign language packaging. For medicinal products intended to be delivered directly to patients, the Estonian-language PIL has to be added to each package. This can be done at the manufacturing site specified in the MA documentation or under agreement with the State Agency of Medicines, by another activity licence holder for manufacturing of medicinal products.

    For hospital-use only or vet-use only medicinal products, adding a printed PIL is not required. In these cases, the MAH must inform the hospital pharmacies/healthcare institutions/veterinarians who use this medicinal product, that the medicinal product is distributed in packaging of another member state of the EEA and send them the latest updated version of the PIL as well as the reference to the PIL in the Register of Medicinal Products electronically.

    Over-stickering of a foreign language packaging with a sticker in the national language can be accepted subject to the same conditions, i.e. the medicinal product is no intended to be delivered directly to patients or medicinal products with the same active substance and of the same strength are not distributed in Estonia.

    It is also possible to over-sticker the packages of centrally authorised medicinal products, but the process of over-stickering must be done at the manufacturing site specified in the MA documentation and must be co-ordinated with the European Medicines Agency (EMA).

    The European Medicines Agency has published the guidance on exemptions to labelling and package leaflet obligations for centrally authorised products.

    The signed application form should be sent to documentation@ravimiamet.ee