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    Requirements for signatures

    27.03.2015
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    The following documents must be signed by the applicant. Hand-written signatures, digital signatures and mechanical (scanned) signatures are acceptable) for the documents listed below

    • Application for marketing authorisation
    • Application for renewal of marketing authorisation
    • Application for variation to marketing authorisation
    • Letter of access to Active Substance Master File
    • Letter of authorisation for communication on behalf of the applicant/MAH
    • Informed consent letter of marketing authorisation holder of authorised medicinal product for Article 10c ‘informed consent’ applications

    The following documents are required with original signature or digital signature (in accordance with the Digital Signatures Act)

    • Withdrawal letter of a marketing authorisation application
    • Withdrawal letter of an application for renewal of marketing authorisation
    • Withdrawal letter of a marketing authorisation

    Withdrawal letter of a variation application may be submitted as an e-mail attachment.