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    Variations

    25.04.2017
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    The variations to the terms of marketing authorisations for human and veterinary medicinal products are governed by the EC Regulation No 1234/2008.

    The Regulation is applicable for centrally authorised, MRP/DCP and national marketing authorisations.

    The use of the eAF (electronic application form) is mandatory from 1st January 2016 for all applications (human and veterinary MRP, DCP and national procedure applications for marketing authorisation, renewal and variations). Further details can be found on: http://esubmission.ema.europa.eu/eaf/index.html and CMDh website.

    EC Guidelines on the details of the various categories of variations

    CMDh guidance on variations

    CMDv guidance on variations

    Submission of safety variations following signal and PSUR assessment outcome


    How to submit a variation for Transfer of Marketing Authorisation?
    A Transfer of Marketing Authorisation (MA) from the existing Marketing Authorisation Holder (MAH) to a new MAH has to be submitted nationally (also for MRP or DCP) as type II variation no A.z – Transfer of marketing authorisation to different legal entity.

    Document requirements:

    1) Declaration stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements and the Transferee takes over all responsibilities (must be signed by both the Transferor and the Transferee).
    2) Contact details of the person responsible for communication between the MAH and State Agency of Medicines and letter of authorisation.
    3) Information on whether the pharmacovigilance system and Qualified Person for pharmacovigilance remain the same or are changed.
    4) Revised product information and the implementation date of the variation.
    5) Proof of establishment of the MAH in the EEA.

    Remarks:

    To introduce a new pharmacovigilance system of the new MAH a suitable variation should be submitted. For products registered through MRP or DCP, it is processed at MRP level.