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    Information for marketing authorisation holders: date of approval of variations

    30.09.2020
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    In order to harmonise the approval of variations of medicinal products authorised via mutual recognition or decentralised procedures and to ensure the smooth supply of medicinal products, experts from the Baltic agencies agreed on a single date of approval of IA, IB, II type variations. For changes involving Estonia and / or Latvia and / or Lithuania as the concerned member states, the reference member state’s (hereinafter - RMS) approval date will be indicated in section 10 of the Summary of Product Characteristics and section 6 of the Package Leaflet. It is the MAH responsibility to indicate correct date in above mentioned sections.

     

    Possible exceptions:

    • If changes related with transfer of MAH affect the name of medicinal product – date should be agreed nationally.
    • If there are several variations and MAH/Agency wishes one approval date – date will be the latest variation’s RMS approval date.

    It is planned that this agreement will enter into force on the 1st of November, 2020.

    Your suggestions and recommendations are welcome until 16th of October 2020 by e-mail to margit.plakso@ravimiamet.ee