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    Notification for marketing authorisation holders (hereinafter - MAH): date of approval of variations, updated after comments received

    29.10.2020
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    Taking into account MAHs’ comments and necessity to ensure smooth supply of medicinal products authorised via mutual recognition or decentralised procedures (hereinafter - MRP/DCP), the following dates should be indicated in section 10 of the Summary of Product Characteristics and section 6 of the Package Leaflet (hereinafter - PI):

    • Type IA variations – implementation date of Type IA variation should be stated as the last revision date of PI. The MAH is responsible for indicating the correct date in PI;
    • Type IB variations - RMS approval date should be stated as the last revision date of PI. The date would be amended by the Agency during the review process of the national translation of PI;
    • Type II variations - RMS approval date should be stated as the last revision date of PI. As there is a national phase foreseen, the MAH is responsible for indicating the correct date in PI.

     

    Possible exceptions:

    • If changes are related to the transfer of MAH and transfer affects change of the name of the 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.
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    This concerns only national, not common texts.

    The format of the date should be according to the QRD template.

    This agreement has been concluded by mutual collaboration and agreement between all Baltic Agencies to ensure common and harmonized approach.

    MAH’s are kindly reminded that this agreement and harmonized approach is applicable for MRP/DCP procedures, where Baltic States are involved.

     

    This agreement will enter into force on the 1st of November 2020.

     

    Dear marketing authorisation holders! Thank you for your comments and active participation in the harmonisation process.

    Baltic agencies greatly appreciate it.

    Most of the comments were related to Type IA variations as well as general activities to indicate the RMS approval date for Type IB and Type II variations.